Many people think that participating in a research study means they will get better treatment for their condition. While this may be true, it’s important to remember that a research study is conducted for research purposes—it does not ensure better or safer treatment.

Taking part in a study does not guarantee individual benefits to the participant in the form of newer or safer treatment. The contribution made by participating in a research study is to science first and to the patient second.

DBSA, its advisors, and consultants do not endorse or recommend the use of any specific treatment or medication. For advice about specific treatment or medication, patients should consult their physicians and/or mental health professionals.

To submit a study or research project for consideration, click here.

Depression Studies

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral NMRA-335140 versus Placebo in Participants with Major Depressive Disorder (Protocol #: NMRA-335140-301, Study name: KOASTAL-1)

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the effects of NMRA 335140 (formerly BTRX 335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA 335140 or a placebo). After the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an extension study (NMRA 335140 501).

Participants are restricted from taking psychotropic medications.

Active NMRA 335140 or matching placebo; 50-50 chance.

Contact
888-490-1011
explore@koastalstudy.com

Deadline for Enrollment: 12/31/24


A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Restriction: Use of all concomitant medications will be recorded in the patient’s eCRF. Drug name and dates of administration must be recorded for all prescription drugs, herbal products, vitamins, minerals, and over-the-counter medications. Any changes in concomitant medications will also be recorded in the patient’s eCRF. Any concomitant medication deemed necessary for the welfare of the patient
during the study may be given at the discretion of the Investigator, eg, limited, acute prescribed opioid use. However, it is the responsibility of the Investigator to ensure that complete details regarding the medication are recorded in the eCRF.

Placebo: Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.

Contact
Name: ITI Clinical Trials
ITCIClinicalTrials@itci-inc.com
www.MDDclinicalresearch.com
1-844-204-7745

Deadline: 10/31/2025


VENTURA-1 clinical research study is evaluating an investigational medication (oral tablet), added to an ongoing antidepressant for people in depression with loss of ability to feel pleasure.

The VENTURA-1 clinical research study is currently testing an investigational medication for people living with Major Depressive Disorder.

The VENTURA-1 study is enrolling adult and elderly participants up to 74 years of age with Major Depressive Disorder with moderate to severe anhedonia (loss of pleasure) to evaluate the efficacy of an investigational medication compared to placebo. Participants must have had an inadequate response to their current antidepressant therapy to qualify. The study lasts six weeks, and participants may choose to continue into a long-term open-label study following the VENTURA-1 study, which lasts 52 weeks.

Restriction: Participants will continue to take their antidepressant treatment.
Participants do not receive any other medication besides the study medication during the trial.

Placebo: Yes – there are 2 treatment group with equal chance of being put in either group:
1) Participants will receive the investigational medication tablets orally once daily for 42 days
2) Participants will receive matching placebo orally once daily for 42 days

Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Deadline: 2024-08-11


VENTURA-2 clinical research study is evaluating an investigational medication (oral tablet), added to an ongoing antidepressant for people in depression with loss of ability to feel pleasure.

Description: The VENTURA-2 clinical research study is currently testing an investigational medication for
people living with Major Depressive Disorder.

The VENTURA-2 study is enrolling adult and elderly participants up to 74 years of age with Major Depressive Disorder with moderate to severe anhedonia (loss of pleasure) to evaluate the efficacy of an investigational medication compared to placebo. Participants must have had an inadequate response to their current antidepressant therapy to qualify. The study lasts six weeks, and participants may choose to continue into a long-term open-label study following the VENTURA-2 study, which lasts 52 weeks.

Restriction: Participants will continue to take their standard mood stabilizing treatment.
Participants do not receive any other medication besides the study medication during the trial.

Placebo: Yes – there are 2 treatment groups with an equal chance of being put in either group:
1) Participants will receive 10 milligrams (mg) tablet of the investigational medication orally, once daily for 42 days
2) Participants will receive matching placebo tablet orally, once daily for 42 days

Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Deadline: 2024-10-27


Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)

This research study is testing a new type of electroconvulsive therapy (ECT) to see if it is a safe and effective method to rapidly reduce and treat depression. With this new type of ECT we decrease the strength of the electric pulse to see if that causes less memory side effects than regular ECT.  We use brain imaging to better understand how the new treatment affects the brain and how this relates to changes in depression or memory.This inpatient study is enrolling adults with major depressive disorder, ages 22-70. Participants will be free of other serious medical conditions and have tried other treatments and failed to improve. Research participation is 4- to 12 weeks and includes 7 sessions of the experimental ECT, brain imaging, transcranial magnetic stimulation (TMS) assessment, and memory and thinking assessments. All research participants can receive sessions of regular ECT if needed after the experimental ECT part is over.The study is conducted at the NIH Clinical Center in Bethesda, MD. There is no cost to participate, and compensation is provided. This study enrolls eligible participants from across the USA. Travel arrangements are provided, and costs are covered by NIMH (arrangements vary by distance). After completing the study, participants receive short-term follow-up care at the NIH while transitioning back to a provider.

Eligibility

  • Diagnosed with Major Depressive Disorder
  • Between the ages of 22-70

Deadline for Enrollment

01-01-2027

Contact
William T. Regenold
301-793-4897
william.regenold@nih.gov


Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)

Mood disorders are associated with significant financial and health costs for the United States, partially due to cognitive problems in these patients that can worsen disease course and impair treatment response. This study proposes to use smartphone-based technology to monitor cognitive problems in patients with mood disorders by linking brain network changes with predicted worsening of mood symptoms. The proposed study will provide evidence for using smartphone-based passive sensing as a cost-effective way to predict illness course and treatment response.

Multiple mood disorders are employed, in line with the Research Domain Criteria (RDoC; (53)) framework and the relative imprecision of current symptom diagnostic clusters for tracking treatment responses and course of disease. To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.

Eligibility

  • 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51);
  • Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia.
  • Own a BiAffect-compatible smartphone.

Exclusion Criteria:

  • Active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)(50), suicide attempt in the last 3 months
  • Severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay)
  • Active moderate or severe alcohol and/or substance use disorders;
  • Major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and
  • Presence of contraindications to MRI.
  • Pregnancy (positive pregnancy test), trying to become pregnant, or lactation.

Contact
Andrea Cladek
312-996-6620
nmasckstudy@uic.edu


The RELIANCE Program: RELIANCE I, RELIANCE II, and RELIANCE Open Label Study (OLS)

The RELIANCE Clinical Research Program is currently testing REL-1017 as an investigational medication for people living with Major Depressive Disorder (MDD).

The RELIANCE Clinical Research Program includes studies comparing REL-1017 to placebo over a treatment period of 28 days, either as an adjunctive (or add-on) treatment with a standard antidepressant or as a monotherapy (if not currently taking an antidepressant medication). Participants of the placebo-controlled studies may choose to continue into a long-term safety study. All participants in this long-term safety study will receive REL-1017, and it will continue for at least one year. Participants may also join the long-term study directly, without first participating in a placebo-controlled study.

RELIANCE OLS: Phase 3 open-label study in which all participants will receive REL-1017 in addition to their current antidepressant therapy for one year.

Eligibility

  • Adults 18-65 years
  • Have been diagnosed with Major Depressive Disorder and are currently experiencing depression
  • Currently taking antidepressant medication

Contact
Relmada Clinical Trials
Phone: 332-900-5901
Email: clinicaltrials@relmada.com

Deadline for Enrollment
Ongoing

Learn more about participating in the study


COVID-19 and daily routines: The experience of people with mood disorders

Many governments have instituted social distancing and social isolation measures to curb the spread of the COVID-19 virus. This has caused many people to experience changes in their normal and structured social routines of work, study, and other lifestyle activities. We want to understand the challenges individuals diagnosed with mood disorders face, particularly with respect to their social rhythms during a time of restricted socializing and modified daily routines.

Participation involves completing a brief online survey (20-30 minutes). You will be asked some basic information about yourself, some questions about your current mood symptoms, stress, social rhythmicity and sleep as well as your experiences around evidence-based psychological therapies. The research is led by professor Greg Murray of Swinburne University of Technology.

Eligibility

  • Have received a diagnosis of depression or bipolar disorder
  • Are age 18-65
  • Are fluent in English

Contact
Gwmurray@swin.edu.au

Deadline for Enrollment
Ongoing

Learn more about participating in the study


Depression Research Study (Ann Arbor)

The purpose of this study is to examine the relationship between emotion and memory. The goal of this study is to try to understand how the brain processes information in those with Major Depressive Disorder by understanding how interference is resolved in perceptual, memory, and motor processes. This, in turn, may help us understand ruminative processes among depressed individuals.

In this study, participants will first be asked to undergo a clinical diagnostic interview with a trained clinician, graduate student, post docs, or other trained personnel who have undergone formal training in administering the interview. During that time we will ask you questions about your emotional and physical well-being. This interview, which will last approximately 1-2 hours, will help determine if participants are eligible to continue in the study. This session pays $20.00 an hour.

If eligible, participants will be invited back to participate in various studies, which include performing computer-based tasks. Participants will also be asked to complete several questionnaires pertaining to their moods and emotions. This session pays $20.00 an hour as well.

Eligibility
Has been diagnosed with Major Depressive Disorder

Contact
Catherine
734-647-6249
jlabfbstudy@umich.edu

Deadline for Enrollment
Ongoing


Mothers with Depression Needed

Are you a mother with a daughter who is 9-14 years old? Have you had episodes of depression during your daughter’s lifetime?
If so, you may be eligible to participate in a study of how moms and their daughters think and process emotional information.

The study takes place in the Psychology Department at Stanford University. You and your daughter would participate in interviews, fill out questionnaires, do computer tasks, have discussions with each other, and possibly be eligible for a brain scan. Involvement in the study requires a time-commitment of 3-10 hours over the course of one to three visits. We will schedule the sessions around your availability (daytime, evenings, or weekends are all fine).

Eligible pairs receive $40/hour for their time. Your performance in all study-related activities, including requests for information will be kept completely confidential.

Eligibility

  • You must have a daughter between the ages of 9 and 14
  • You must have had episodes of depression during your daughter’s lifetime
  • You must be a US citizen or hold a Green Card
  • You must read and speak English fluently
  • You should have no immediate plans to leave the Bay Area

Contact
mood@psych.stanford.edu or call (650) 723-0804 to reach the study coordinator, Hannah Burley. Please refer to study #101. For general information about participant rights, contact 1-866-680-2906.

Deadline for Enrollment
Ongoing


Sleep and Memory Study

Depressed participants needed. Monetary compensation of $75 per lab night.

Eligibility

  • Males and females over the age of 18
  • No history of head injury causing unconsciousness
  • Able to spend two to four nights in the lab and keep a fixed sleep schedule
  • Willing to complete interview, questionnaires, and computer tasks

Contact
Adrienne McHenry
248-719-3887
amchenry@umich.edu

Deadline for Enrollment
Ongoing


Depression Research Study

Feeling overwhelmed? Sad? Depressed? You may be suffering from depression. Doctors at the University of California Los Angeles are researching a new technology to predict antidepressant effectiveness.

Qualifying participants, ages 18-75, will receive antidepressants, study-related exams, tests and clinical consultations – at no cost. Also, monetary compensation may be provided. We conduct numerous studies on depression and enrollment is ongoing.

Eligibility
Age 18-75

Contact
Lab of Brain, Behavior, and Pharmacology
310-825-3351
rohitm@brain.ucla.edu
http://www.brain.ucla.edu/

Deadline for Enrollment
Ongoing


Depression Research Study (Southern California)

A Placebo-Controlled, Add-On (“Natural Supplement”) Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder (MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy

The purpose of this study is to evaluate the safety and effectiveness of MSI-195 (SAMe) as an add-on treatment to an ongoing antidepressant medication. Qualified participants must be between 21 and 70 years of age and diagnosed with Depression. The duration of study participation is approximately two-to-three months, with up to six clinic visits and three telephone visits. Study-related care is provided at no cost to participants and compensation for travel is available.

Pharmacology Research Institute (PRI) has been conducting research studies since 1975. Our offices are located in Orange County, Long Beach/Los Alamitos and Encino/San Fernando Valley. Please feel free to contact us or visit our website for more information.

Eligibility

  • Age 21-70
  • Diagnosed with depression

Contact
Mellissa M. Henry, R.N., M.S.N., N.P.
(888) 774-4673 or (714) 827-3667
mhenry@priresearch.com
www.priresearch.com

Deadline for Enrollment
Ongoing


Deep brain stimulation for TRD

This study, conducted by Dr. Helen Mayberg, is looking at deep brain stimulation for the treatment of patients with treatment resistant depression. We are currently recruiting patients with bipolar type II depression and unipolar depression. For more information please contact us or visit our clinical trials website at: http://clinicaltrials.gov/ct2/show/NCT00367003?term=deep+brain+stimulation+for+depression&rank=6

Eligibility
Bipolar type II depression and/or unipolar depression

Contact
Megan Filkowski
dbs@emory.edu
(404)727-9228
http://clinicaltrials.gov

Deadline for Enrollment
Ongoing

Adolescent Depression Studies

None at this time.

Bipolar Studies

Positive Emotion Dysregulation (PED) in Bipolar Disorder Onset and Illness Course in Emerging Adults: Young Emerging Adult Research Study (YEARS)

This project is testing the contribution that Positive Emotion Dysregulation processes make to Bipolar Disorder risk across three groups (low risk, high risk, and already diagnosed with BD) over a 24-month period. Participants may be asked to participate in four different phases of the study. We will use both neuroimaging and behavioral tasks to test the differences between the groups.

We aim to understand how positive emotions relate to mental health, including diagnoses of and risk for bipolar disorder. Participants will be asked to look at different pictures and videos and complete computer tasks. Some will have brain scans and will be asked to complete follow-up interviews about their moods, to track how emotions predict changes in mental health. Pays $25 per hour.

Contact
Ethan Robinson
303-735-7547
years-study@colorado.edu

Deadline for Enrollment
4/1/27


The Earliest Signs and Symptoms of Bipolar Disorder from Infancy to Age Three

This study aims to identify the earliest neurodevelopmental signs or symptoms of bipolar disorder in children who have been diagnosed with bipolar disorder during childhood. Parents will be asked to complete a questionnaire describing their child’s developmental behaviors during infancy to the age of three.

This is a quantitative, IRB approved study. Parents will be asked to complete a basic family medical history and a 40-question assessment to determine skills and behaviors during infancy through the age of three in areas of motor development,  emotional development, arousal, regulation, sensory processing. Parents often report specific developmental concerns during the first few years of development in children with mental health conditions or developmental disabilities. This study aims to capture those experiences that may signal irregular development in the earliest years of life.

Contact
Cynthia Preston
1-614-746-5097
cynthia.preston@ivyrehab.com

Deadline for Enrollment: 7/12/24


Improving Mental Health Diagnosis with Questionnaire and Interview Assessment

This online study can be completed by participants anywhere in the United States. It involves completing an interview with our staff using a HIPAA-secured Zoom platform and an online survey administered via secured survey software. Involvement in the study requires 1.5-2 hours of your time, and $35 compensation is provided.

The purpose of this study is to improve the process of how clinicians make mental health diagnoses and communicate information about mental health. Participants will be asked a series of structured questions about bipolar disorder, depression, anxiety, their relationships, and their personalities.

All participants must be 18 years or older, be their own legal guardians, comfortable communicating in English, and currently residing in the United States. There are no other restrictions on eligibility. Please contact us at wyomingpersonalitylab@gmail.com to request more information or to signup for the study.

Kasey Stanton
540-944-8235
wyomingpersonalitylab@gmail.com


 

Experiential Factors Contributing to Social Connections Among Adults with Serious Mental Illnesses

This project proposes to study the ongoing experiences of social isolation and loneliness to identify risk and protective factors among adults with serious mental illness (SMI). Experience sampling will be used to achieve near real-time data collection from study participants using surveys. Over a two-week period, participants will receive prompts four times per day to complete a short survey via smartphone. Each survey will take 1-3 minutes to complete.

Participants will be asked questions about quality of experience, social context and satisfaction, mattering components, kindness, gratitude, and loneliness. In addition, we will gather data on demographic background, life transitions, social network characteristics, internalized stigma, neighborhood climate, depression, and trait measures of mattering and loneliness during intake and exit interviews. We plan to recruit 120 individuals with SMI (including depression, bipolar disorder, and schizophrenia) over a 15-month period. The study aims to identify how mattering, kindness, and gratitude are experientially linked to social isolation and loneliness in everyday life, with the potential to guide more impactful intervention approaches for adults with an SMI diagnosis.

Participants will receive a $20 gift card after completing their intake interview, and a $30 gift card after completing their exit interview 2 weeks later.

Contact
Tabea Neumann & Sabrina Giaimo
(267) 603-2703
drrp@temple.edu
https://tucollaborative.org/drrp/


 

Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)

Mood disorders are associated with significant financial and health costs for the United States, partially due to cognitive problems in these patients that can worsen disease course and impair treatment response. This study proposes to use smartphone-based technology to monitor cognitive problems in patients with mood disorders by linking brain network changes with predicted worsening of mood symptoms. The proposed study will provide evidence for using smartphone-based passive sensing as a cost-effective way to predict illness course and treatment response.

Multiple mood disorders are employed, in line with the Research Domain Criteria (RDoC; (53)) framework and the relative imprecision of current symptom diagnostic clusters for tracking treatment responses and course of disease. To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.

Eligibility

  • 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51);
  • Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia.
  • Own a BiAffect-compatible smartphone.

Exclusion Criteria:

  • Active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)(50), suicide attempt in the last 3 months
  • Severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay)
  • Active moderate or severe alcohol and/or substance use disorders;
  • Major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and
  • Presence of contraindications to MRI.
  • Pregnancy (positive pregnancy test), trying to become pregnant, or lactation.

Contact
Andrea Cladek
312-996-6620
nmasckstudy@uic.edu


Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder (iTAB-CV RCT)

This research study is to evaluate if educational and motivational text messages might help patients take their medication for high blood pressure and bipolar disorder more regularly.Participants must have bipolar disorder and high blood pressure, be between the ages of 21 and 80, have a cell phone, take medication for high blood pressure, and have recently missed taking some medication.Study participants will be randomly assigned to the self-monitoring group or self-monitoring plus active treatment group. Both groups are asked to complete psychological assessments, measure their blood pressure, participate in a customized educational program delivered through text messages, followed for 12 months, and will receive compensation for their study visits.Participants are able to complete study visits remotely, from their homes, due to COVID-19.

Eligibility

  • Live with bipolar disorder and high blood pressure
  • Ages 21-80
  • Have a cell phone
  • Take medication for high blood pressure
  • Have recently missed taking some medication

Contact
Celeste Weise
Phone: 888-819-0004
Email: BPstudy@uhhospitals.org

Deadline for Enrollment
10/31/2024


BiAffect: a ResearchKit study to unobtrusively understand mood and cognition in bipolar disorder (iPhone)

Currently, diagnosis and treatment of bipolar disorder rely on careful history taking and mental status examination by an experienced clinician, at times aided by self-report or family-informed questionnaires. These reports, as well as in-person assessments, have to be interpreted by providers in order to extract patterns that could indicate an imminent change in mood. When individuals experience changes in mood, they also may struggle with navigating daily activities—especially ones with high cognitive demand.

With the expanding coverage of wireless Internet access and rapid advancement of mobile smartphone technologies, people are increasingly interacting via typed (rather than oral) communications. BiAffect’s innovative approach aims at understanding and examining the ubiquitous ‘virtual mental-health footprints’ or ‘signatures’ of abnormalities in people suffering from mood disorders, notably abnormalities in cognitive skills.

Contact
Email: BiAffect@psych.uic.edu
https://itunes.apple.com/us/app/biaffect/id1355144276?mt=8

Deadline for Enrollment
Ongoing


Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial (Providence, Rhode Island)

Adults with Bipolar I Disorder who struggle with symptoms of depression despite medication treatments receive a diagnostic evaluation and (if eligible) up to 30 daily treatment sessions (weekdays over six weeks) with an investigational device that delivers Transcranial Magnetic Stimulation (“TMS”) synchronized with the participant’s alpha brain waves. Participants may also have a functional Magnetic Resonance Imaging (fMRI) brain scan before and at the end of the clinical trial. Participants remain on their stable psychiatric medication regimens, and the TMS treatments are “active” for all study participants, i.e., no one will get a “placebo” or “sham” TMS.

Participants will not be able to change medications during the six weeks of the study unless medically necessary.

Contact
Dr. Jorge Almeida
Phone: 401-455-6623
Email: jalmeida@butler.org

Deadline for Enrollment
Ongoing


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating the Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression (Hoffman Estates, IL)

This study lasts approximately nine weeks, including a screening period of up to 14 days, followed by a six-week treatment period and one-week safety follow-up period.

Exclusion criteria includes prior participation with any clinical trials, involving experimental or investigational drugs, within six months. Initiation or termination of psychotherapy for depression within the three months. Treatment period is six weeks where participants will be randomized to receive either 1.5mg , 3.0mg of study drug or placebo.

Eligibility
You may be eligible to participate in this study if you are between 18-65 years old, have been diagnosed with Bipolar I Depression, are currently suffering a major depressive episode that has lasted more than four weeks but not longer than 12 months.

Contact
Linda Orgler
Phone: 847-230-3591
Email: PsychResearch@amitahealth.org

Deadline for Enrollment
Ongoing


A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC-34712) in Adolescents with Schizophrenia or Other Related Psychiatric Disorders (Baltimore, MD)

This research study is being conducted by Kennedy Krieger Institute/centers across the United States to determine whether brexpiprazole is safe and effective in adolescents with schizophrenia or a related psychiatric disorder.

If eligible, the participant will visit the Kennedy Krieger Institute up to nine times over a period of 102 days. Each visit will take between 30 minutes and two hours and will include psychological and behavioral testing, medical history, physical examination, blood draws, HIV testing, vital sign, ECG, urine drug screen, and pregnancy testing for females.

For each completed visit, participants will receive a reimbursement of $75.00 for their time and travel expenses. Please ask a study team member for specifics. All testing is done free of charge.

Contact
Rebecca Hinton
Phone: 443-923-3850
Email: researchtrials@kennedykrieger.org

Deadline for Enrollment
Ongoing


Rapid Antidepressant Effects of Ketamine in Bipolar Disorder (Bethesda, MD)

Bipolar disorder and major depressive disorder (MDD) are common, severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants. In two separate trials, we tested riluzole (an inhibitor of glutamate release) and found it to have antidepressant properties in patients with MDD and bipolar depression (BD). In another study (Substudy 1), we found that the non-competitive NMDA antagonist (ketamine) was effective in treatment-resistant MDD. Ketamine resulted in rapid, robust and relatively sustained antidepressant effects. Response with ketamine occurred within two hours and lasted approximately one week. The current protocol consists of six sub studies designed to address six major questions. Two of these studies (1 and 5) have met their enrollment quota and sufficient analyzable data has been obtained.

Standard antidepressant medications can take weeks or months to achieve their full effects. Several studies seek to better understand the causes of depression and evaluate the mechanisms in the brain that are related to rapid antidepressant improvement. NIH studies enrolls depressed persons between the ages of 18 and 65 (or those with bipolar disorder who are currently in a depressive phase) for an inpatient period of two to three months. Researchers will evaluate how the experimental medication ketamine, versus placebo, affects glutamate in the brain and whether a rapid reduction of antidepressant symptoms (within hours) can be achieved and sustained.

The studies are conducted at the NIH Clinical Center in Bethesda, Maryland. There is no cost to participate. We enroll eligible participants locally and from around the country. Travel arrangements provided and costs covered by NIMH. (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.

Participants who consent will have a multimodal MRI and MEG scan in the drug-free period before receiving the intravenous infusion of either ketamine or saline solution. They will repeat the MEG procedure 4-5 hours after each of the two infusions, and will repeat the MRI procedure between the day of infusion to two days following the infusion.

Participants who show an antidepressant response (50% reduction in MADRS) following infusion 1 or infusion 2 will undergo an interim assessment using the same MRI and MEG scan battery to assess relapse (if the response is lost) or sustained response (if the response is retained) 10 to 11 days post-infusion, depending on availability of scanning resources. Non-responders will undergo the interim MRI and MEG scan sessions at 10 to 11 days post-infusion as scan-time allows.

In a subset of 26 participants, total sleep deprivation (TSD) for 40 hours (7am to 11pm the subsequent day) will be investigated at the behavioral and neural level as a rapid acting antidepressant prior to Phase II of this study. Individuals who participate in this optional component of the subs study will require an additional seven days for their drug free period. In the evening prior to the sleep deprivation period, participants will undergo a baseline 3T MRI (within two days of TSD) and a high field 7T MRI scan (within two days of TSD) to acquire images of the brain prior to sleep deprivation. This will be followed by one 7T scan after the sleep deprivation period toward the end of the 40-hour period, but before recovery sleep. During the MRI scan participants will play a simple reward-learning task and also perform a cognitive emotional task whereby emotional faces will be presented, while functional images are acquired. Additionally, two MEG scans and two sleep EEGs will be acquired to examine the electrophysiology of response and relapse. During the MEG scan participants will wear an MEG compatible EEG cap and leads. Total sleep deprivation will occur approximately one week following the beginning of the drug-free period.

Eligibility
MDD or BD
Male or female subjects, 18 to 55 years of age
Age of onset less than 40 years of age
Female subjects of childbearing age must be using a medically accepted method of contraception
Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
Subjects must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features, or Bipolar Disorder (296.5 for Bipolar I Disorder or 296.89 for Bipolar II Disorder) without psychotic symptoms based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).
Subjects must have an initial score on the MADRS of at least 20 at screening, and at baseline for Phase I of Substudy 4. Subjects with bipolar disorder must have a YMRS of 12 or less at baseline for Phase I.
Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
Current major depressive episode of at least four weeks duration.
In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
Exclusion criteria for participants with MDD or BD
Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
Subjects with a history of DSM-IV drug or alcohol dependence or abuse (except for caffeine or nicotine dependence) within the preceding three months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances in the two weeks prior to screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) at screening.
Female subjects who are either pregnant or nursing.
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
Clinically significant abnormal laboratory tests.
Subjects with clinical hypothyroidism or hyperthyroidism.
Subjects with one or more seizures without a clear and resolved etiology.
Treatment with a reversible MAOI within two weeks prior to Phase I of Substudy 4.
Treatment with fluoxetine within five weeks or aripiprazole within three weeks before Phase I of Substudy 4.
Treatment with any other concomitant medication (Appendix 4) 14 days prior to Phase I of Substudy 4.
Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
Subjects who, in the investigator’s judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of >4.
Inclusion criteria for control subjects
Written informed consent completed. In women of childbearing age, a negative pregnancy test within 24 hours of MRI

Contact
Libby Jolkovsky, M.S.
Phone: 301-402-9347
Email: jolkovsl@mail.nih.gov
http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml

Deadline for Enrollment
Ongoing


NIH Research Studies: Bipolar Disorder & Severe Irritability Symptoms (Bethesda, Maryland)
How do the brain and the symptoms change as children grow up?

Researchers will describe over time the moods and behavior of children, using specialized testing and brain imaging to learn about specific brain changes associated with bipolar disorder or severe irritability in children. Studies involve 1-5 outpatient visits, with follow up visits as the child grows up. All clinical evaluations, research procedures, and outpatient visits are free of cost. Children and parents are compensated for participation. Travel and lodging expenses are paid by NIMH.
Participants must have a bipolar diagnosis, or have symptoms of severe irritability. Irritability symptoms include: difficulty handling frustration (severe temper tantrums and rages) and “hyper” behavior (distractible, hyperactive, trouble sleeping).

Eligibility
Ages 6-17

Contact
NIMH Irritable Kids
Phone: 301-496-8381, TTY: 1-866-411-1010
Email: irritablekids@mail.nih.gov
http://patientinfo.nimh.nih.gov/BipolarD

Deadline for Enrollment
Ongoing


Adolescent Bipolar Disorder Studies

Developing Brain Function in Adolescent Bipolar Disorder (Chicago, IL)

This study focuses on the developmental changes in cognitive and affective neural circuitry functioning in adolescents with Pediatric Bipolar Disorder (PBD) over a three-year period. We will characterize the course of illness and associated neurocognitive function in patients with PBD as well as determine the association between brain function and behavior.
During the study, participants will complete a baseline diagnostic interview, clinical assessments, neurocognitive and neuropsychological tests, and a functional MRI brain scan. Participants will also have the option to draw blood for pharmacogenetic analyses. Testing will be repeated once a year for three years after the baseline visit, for four visits total.

Contact
Allison Lowes
Phone: (312) 355-1168
Email: alowes@psych.uic.edu

Deadline for Enrollment
Ongoing

Multiple/Other Studies

Massachusetts General Hospital Postpartum Psychosis Project (MGHP3)

The primary goals of our study are to describe the risk factors of PP and to examine how genes affect risk of this disorder. If you have experienced a psychotic episode within 6 months of giving birth in the past 10 years and are over 18, you could help us understand this illness to provide better care for future patients potentially at risk for postpartum psychosis. https://www.mghp3.org/about-our-research

Contact
617-643-7205
mghp3@partners.org

Deadline for Enrollment
1/1/27


Depression & Transcranial Electric Stimulation Therapy (TEST)

Researchers are testing a new type of non-invasive brain stimulation treatment to see if it is safe and potentially helpful to treat depression symptoms. Some participants are assigned to a placebo (no-treatment) group for the first 6 treatments but will be switched to the treatment group afterward.

For more details visit: https://www.nimh.nih.gov/research/research-conducted-at-nimh/join-a-study/adults/depression-transcranial-electric-stimulation-therapy-test

Contact
William T. Regenold, MDCM
301-827-1874 [TTY: 711]
depressionresearch@nih.gov

Deadline for Enrollment
1/1/27


The liVed experIence of cognitive difficultieS in BipoLar, depression and psychosEs (VISIBLE)

This international, online survey seeks to understand more about the thinking skill experiences of people with bipolar disorder, major depressive disorder, and schizophrenia spectrum disorders.

If you have one of these mental health conditions, you are invited to provide your perspectives and input in relation to how difficulties you may have experienced in your thinking skills impact your life, relate to your other symptoms, and are dealt with by your doctors. Thinking skill difficulties encompass things like brain fog, or difficulties in being able to remember information, concentrate, plan, problem solve and pick up on social cues (for example, facial expressions) in the environment.

The survey also asks about what research you think researchers should be doing to better understand thinking skills in those with mental ill-health. Participating in the survey gives you an opportunity to contribute to influencing the direction of research in this area and the way in which thinking skill difficulties are recognized and treated.

This VISIBLE survey was designed in collaboration with lived experience advisors and is led by researchers from the Mood Psychosis Spectrum Research Group (MPSG) at The University of Melbourne in Australia. It can be completed by anyone aged 18 or older experiencing depression, bipolar disorder and/or a schizophrenia spectrum disorder around the world.

Participation is voluntary and anonymous. You can find out more by contacting the MPSG team at mpsg-research@unimelb.edu.au or reading the information sheet/accessing the survey here:

https://melbourneuni.au1.qualtrics.com/jfe/form/SV_78v0mQDymiEFn26


Identifying Personal and Environmental Factors Supporting Community Participation

The Temple University Collaborative on Community Inclusion is conducting a cross-sectional study on factors supporting community participation among adults with serious mental health conditions. The overall objective of the study is to understand of the relationship between community participation of individuals with serious mental health conditions and other factors such as exposure to trauma or experience of stigma, to identify new targets for future interventions. We aim to recruit and enroll 300 participants for this study. Participants in this study will be asked to complete a one-time interview that takes approximately 2 hours. The interview asks questions about life experiences, experiences with mental health, stigma, hospitalizations, etc. There are also questions designed to test attention, memory and spontaneous thinking.

Contact
Katherine Arazawa
215-204-5593
kathy.arazawa@temple.edu

Deadline for Enrollment: 9/25/25


ConnectionsRx

The Temple University Collaborative on Community Inclusion is conducting an intervention efficacy study to test ConnectionsRx, a technology-based, distance intervention to increase community participation of emerging adults with serious mental illnesses.

Intervention: The 1-1 ConnectionsRx intervention will focus on setting personal participation goals and processing participation in rewarding activities with follow-up on specific commitments to participation, reinforcing goals accomplished and exploring barriers and facilitators for goals not accomplished. A peer-based social media support group will be designed as a place to share resources, connect with others who may have similar interests, facilitate group activities that promote participation, and provide opportunity for discussions.

Participants will be assigned to the experimental or control group and will be enrolled for six (6) months. Intervention participants will have regular contact with a support interventionist and peer support group. Control participants will receive an informational manual. All participants will complete three surveys with a research assistant via Zoom. Surveys will take approximately 60 minutes. In appreciation of their time, they will receive a $30 gift card for each interview completed, for up to $90 in gift cards.

Eligibility: We are seeking to recruit individuals who:
1. Are between the ages of 18 and 30
2. Have an SMI diagnosis (bipolar, major depression, or a schizophrenia spectrum disorder)
3. Have the ability to speak and understand English
4. Are willing to participate in a social-media peer support and a distance-based community participation intervention
5. Have cell phone access
6. Have the ability to provide informed consent

Here is a unique opportunity for emerging adults (18-30) with mental illnesses to connect with peers and receive 1-1 support to increase participation in enjoyable and personally rewarding activities. The intervention aims to increase community participation, improve social connections, resilience, and competence. Participants will complete 3 surveys throughout the 6 months and receive a $30 gift card for each interview.

50% of participants will be randomly assigned to the control condition. This would last for 6 months, during which time participants will complete 3 research interviews (baseline, 3-month, 6-month). Those in the control condition will not participate in the community participation intervention, but will receive a Leisure Confidence Guide that provides information and worksheets related to community participation and goal-setting.

This is a distance-based intervention, with all interviews/meetings happening over Zoom or phone calls.

Contact
Gillian MacDonald
215-204-5854
gillian.macdonald@temple.edu

Deadline for Enrollment
1/1/25


EPICC: Engaging Parents, Increasing Connections with Children

The Temple University Collaborative on Community Inclusion is conducting an intervention efficacy study on the mechanisms of action and outcomes associated with an Engaging Parents and Improving Connections with Children (EPICC) intervention. A focus on meaningful activities as a family is a potentially valuable strategy for achieving positive parenting outcomes for individuals with SMI.

The Intervention is a remote 10-week program. The intervention will consist of five 90-minute group sessions held every other week over ten weeks. There will also be five individual sessions with parent and interventionist, held over the phone, on alternate weeks from the group sessions, providing opportunities to ask personal questions and problem solve issues. Group sessions will provide information about planning meaningful activities, communicating with the child, and participating in leisure and recreation activities at home and in the community.

Following consent procedures, participants will be randomly assigned to a treatment condition or a waiting control condition. Those assigned to the treatment condition will start the EPICC intervention immediately, while those assigned to the waiting control condition will start the EPICC intervention at week eleven of their time in the study. All participants will complete three data collection interviews- one at baseline, another at 10 weeks, and a final interview at 20 weeks, and offered an honorarium of $20 in gift cards for participation in each of the three data collection interviews, for a total of $60.

We are seeking to recruit individuals who
(1) are ages 18 and older
(2) are an adult parent with an SMI (bipolar, major depression, or a schizophrenia spectrum disorder)
(3) indicate a desire to engage in more meaningful activities with their child, regardless of child’s age.

The EPICC program is a unique opportunity for parents with mental illnesses to receive individualized support and group support from other parents to increase participation in meaningful family activities, both at home and in the community. All eligible and enrolled participants will get to participate in the program. Participants will have the opportunity to receive up to $60 for completing the 3 research interviews.

Half of the participants will be randomly assigned to a 10-week waitlist control, but will then be enrolled in the intervention at week 11. Therefore, all participants will receive the intervention at some point.

Contact
Gillian MacDonald
215-204-5854
gillian.macdonald@temple.edu

Deadline for Enrollment
1/1/25