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 Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder (SOLEO)

This is a Phase 2 study in subjects with MDD currently treated with an oral antidepressant medication with an inadequate response to at least 2 antidepressants. SOLEO will be an outpatient study to assess the safety, efficacy, and tolerability of CLE-100 as compared to placebo.

Eligible participants will be randomized to receive either placebo or CLE-100 (oral esketamine) once daily in addition to their current oral antidepressant monotherapy for 4 weeks. All participants who adequately completed the 4-week Double-Blind Treatment Period and who meet the eligibility criteria will be offered the option to roll-over to a 6-month Open-label Extension (OLE) Treatment Period with CLE-100.

Would participants be restricted from receiving any other treatments while participating in the study? If yes, please describe in detail.

Yes-THC

Would some participants be assigned to a placebo or no-treatment group? If yes, please describe the chance of receiving placebo/no-treatment and how long that would last.

Yes in a ratio of 1:1 during a 4-week Double-Blind period. Upon completion participants will be offered to enter an Open-Label period of 6 months in which they will receive active study drug.

Contact
SOLEO.Study@clexio.com

Trial Web Information: https://osmind.info/DBSA

Deadline for Enrollment: 11/7/2025


The VENTURA-5 study is evaluating an investigational oral medication plus an antidepressant in participants with Major Depressive Disorder who experience a loss of interest and pleasure

The VENTURA-5 clinical research study is currently testing an investigational medication for people living with Major Depressive Disorder.

The VENTURA-5 study is enrolling adult participants up to 64 years of age with Major Depressive Disorder with moderate to severe anhedonia (loss of pleasure). The study will evaluate an investigational oral medication plus an antidepressant to prevent return of their depressive symptoms. Participants must have had an inadequate response to their current antidepressant therapy to qualify.

Total study participation length will vary by participant.

Participants will continue to take their current antidepressant SSRI or SNRI treatment. Participants do not receive any other medication besides the study medication during the trial.

Participants who complete the open-label initial study treatment phase (6 weeks) and the open-label study treatment stabilization phase (10 weeks) will enter the double-blind study treatment maintenance phase (length will vary by participant), where they will be randomized to receive the investigational medication or placebo.

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

Deadline for Enrollment: 8/28/2026


OARS 7 – clinical research study is evaluating an investigational medication (oral tablet) added to an ongoing antidepressant for people with depression.

42847922MDD3003 – OARS 7 study is enrolling adult and elderly participants up to 74 years old with Major Depressive Disorder 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. Part 1 of the study lasts 6 weeks and participants may choose to continue into a long-term open-label study following the OARS

7 Part 1 of the study.

Participants will continue to take their antidepressant treatment.

Participants do not receive any other study medication from site staff besides the investigational medicine and/or placebo during the trial.

Part 1 participants will have equal chance to receive either the investigational medication tablet orally once daily for 42 days or the matching placebo orally once daily for 42 days for Part 2 participants will receive the investigational medication tablet orally once daily for up to 16 weeks.

Afterwards they will have equal chance to receive either the investigational medication tablet orally once daily or the matching placebo orally once daily.

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

Deadline for Enrollment: 11/30/2026


42847922MDD3003 – OARS 7 – clinical research study is evaluating an investigational medication (oral tablet) added to an ongoing antidepressant for people with depression.

42847922MDD3003 – OARS 7 study is enrolling adult and elderly participants up to 74 years old with Major Depressive Disorder 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. Part 1 of the study lasts 6 weeks and participants may choose to continue into a long-term open-label study following the OARS

7 Part 1 of the study.

Participants will continue to take their antidepressant treatment.

Participants do not receive any other study medication from site staff besides the investigational medicine and/or placebo during the trial.

Part 1 participants will have equal chance to receive either the investigational medication tablet orally once daily for 42 days or the matching placebo orally once daily for 42 days for Part 2 participants will receive the investigational medication tablet orally once daily for up to 16 weeks.

Afterwards they will have equal chance to receive either the investigational medication tablet orally once daily or the matching placebo orally once daily.

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


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-7 clinical research study is evaluating an investigational medication (oral tablet), added to an ongoing antidepressant for people with depression with loss of ability to feel pleasure

The VENTURA-7 clinical research study is currently testing an investigational medication for people living with Major Depressive Disorder.

The VENTURA-7 study is enrolling adult participants up to 64 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 up to 36 weeks (about 9 months).

Note that only participants who complete the 6-week double-blind phase (randomly assigned to receive either the investigational medication or placebo) may be able to receive the active investigational medication for up to 24 weeks in the adjacent open-label treatment phase.

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

There are 2 treatment groups with equal chance of being put in either group during the blinded study treatment phase:

1.) Participants will receive the investigational medication tablets orally once daily for 6 weeks, OR

2.) Participants will receive matching placebo orally once daily for 6 weeks

Participants who complete the blinded study treatment phase may be eligible to begin the open-label study treatment phase, where they will receive the active investigational medication tablets (not placebo). This phase lasts up to 24 weeks.

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

Deadline for Enrollment: 12/3/2025


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

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

Deadline for Enrollment

1/1/2027


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

Targeting Adolescent Depression Symptoms Using Network-based Real-time fMRI Neurofeedback and Mindfulness Meditation

We are recruiting depressed adolescents ages 13-18 years who are local to the New York or Boston areas. As a participant in our study, we will: (1) interview your child about current and past thoughts, feelings, and behaviors, (2) teach your child mindfulness strategies, (3) collect brain activity data with MRI (non-invasive) while your child practices mindfulness, and (4) send short surveys to your child’s smartphone through the MetricWire app. The MRI scan will take place at the Zuckerman Mind Brain Behavior Institute at Columbia University or the Northeastern University Biomedical Imaging Center. The interviews will take place remotely through Zoom. There also will be a follow-up assessment 1 month after the MRI scan where we will conduct brief interviews. For participating in the study, your child will receive up to $484. To be eligible for this study, your teen must be currently depressed. Interested parents or teens can fill out the following interest form: https://redcap.link/mindfulbrain

Contact
Emma Wool (New York, NY) & Nick Ford (Boston, MA)
646-818-0602 (NY) & 617-870-4899 (MA)
mindfulbrain@nyspi.columbia.edu (NY) & mindfulbrain@northeastern.edu (MA)

Deadline for Enrollment: 5/31/2026

Bipolar Studies

Building Mood State Classifiers to Inform Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment.

It is important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study.

This study is expected to last 20 months and involves 3 main steps.

  1. Medical, psychiatric, and cognitive evaluations.
  2. Implantation of a brain stimulation system.
  3. Follow up after implantation of device, including programming, recording, and psychiatric testing.

There are risks and benefits to this study which need to be considered when deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks.

However, the benefit of this study is that it may help relieve or decrease TRBD symptoms. This form of treatment has shown to reduce symptom severity in other cases. This could potentially improve quality of life and activities in daily routines. There is also a potential benefit to society in that the data the investigators will obtain from this study may help increase the understanding of the mechanisms underlying TRBD symptoms.

Subjects are not restricted from receiving any other treatments while participating. Subjects will be asked to maintain a stable dose of their current clinical medications.

Contact
Michelle Avendano
713-798-4729
mavendan@bcm.edu

Trial Web Information: https://www.bcm.edu/healthcare/clinical-trials/h-53761

Deadline for Enrollment: 1/8/2029


Financial Activity Data as an Objective Behavioral Marker in Bipolar Disorder: A Feasibility and Acceptance Study

Individuals living with bipolar disorder are at an increased risk of financial instability during the course of their illness. For example, one large-scale study found that people living with bipolar disorder type 1 were 50% more likely than the healthy population to have declared bankruptcy.

We believe that modern access to financial data can lead to supportive, privacy-preserving technologies that can help people living with bipolar disorder achieve and maintain financial stability. However, more research is needed to better understand how technology might support the financial lives of people living with bipolar disorder.

Researchers from the Wellbeing and Health Innovation Lab at Penn State University are recruiting participants to better understand the relationships between money behaviors and bipolar disorder.

You can participate in this study if you are age 18 or older, speak English, self-describe as having bipolar disorder (any type), and can access your online banking using the Plaid open banking platform. The study involves one remote Zoom interview (roughly 60 minutes) and includes three surveys.

Participants will be paid a $50 Amazon gift card for their time.

Your participation may contribute valuable information to improve bipolar disorder research!

Contact
(570) 335-8269
brozena@psu.edu

Deadline for Enrollment: 12/31/2026

Validating a Thermally Dysregulated Subtype of Bipolar Disorder

In this research study, we want to learn more about thermoregulation in people diagnosed with Bipolar I. Some people may experience cold insensitivity and heat intolerance symptoms while others may not. We would like to see if there are differences in thermoregulation between individuals diagnosed with Bipolar Disorder I. We are looking for people diagnosed with Bipolar Disorder I and between the ages of 18-40 years old who may or may not experience temperature regulation problems. This study includes two in-person visits to our office in Belmont, MA, and take-home devices, one sleep-monitoring device, and two heat monitoring devices for 1 week. If eligible, you will be invited to the 1st Visit, which can take up to 4 hours. During the first visit, you will complete a drug test, be breathalyzed, fill out questionnaires, and complete a brief intelligence test. At the second visit, you will have an MRI and complete questionnaires. At the end of the second visit, we will send you home with a sleep-monitoring headband and two heat-monitoring devices to be worn for 7 days will sleeping. For participating in this study, you will be paid up to $360.00. Payments will go as follows: Visit #1 ($75), Visit #2 ($125), and take-home devices (up to $140 OR $20/day)

Contact
Lucinda Bond
617 855 2971
lbbond@mgb.org

Deadline for Enrollment: 3/30/2025


 

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

The study will be conducted in 3 phases:

Screening Period (up to 1 week) during which patient eligibility will be assessed.

Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.

Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Participants must discontinue all psychotropic drugs during screening period.

50% chance of getting lumateperone 42mg or matching placebo. Treatment period is 3 weeks.

Contact
Jennifer Cavin
678-559-1119
jennifer.cavin@globales.com

Deadline for Enrollment: 3/30/2026


A Phase 2a, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With a Major Depressive Episode Associated With Bipolar II Disorder

This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.

Subjects will be required to discontinue current inadequate or prohibited medications (as determined by the Medical Monitor per protocol).

This is a randomized controlled clinical trial with a 50/50 chance of receiving a placebo or the study drug for 6 weeks and a 6 week safety follow up period.

Contact
Joyce Su
508-333-5464
joyce.su@neumoratx.com

Deadline for Enrollment: 2025-04-30 4/30/2025


Healthy Lifestyles in Bipolar Disorder

We are studying how dietary interventions, when added to medications, could help improve mood stability and quality of life for those living with bipolar disorder. This study will compare the benefits of two approaches to eating: Mediterranean and Time-Restricted Eating. Neither food plan is a diet or a treatment– we ask you to consume your same amount of food. Payment is $25/assessment hour.

Contact
Nandini Rajgopal
Phone: +1 (510) 519-430
Email: calmprogram@berkeley.edu

Deadline for Enrollment: 11/31/28


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


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


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


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

ENLIGHTEN-Youth Study

The ENLIGHTEN-Youth Study is evaluating how an investigational study drug, olanzapine and samidorphan, may work in children and adolescents with schizophrenia or bipolar I disorder. The study is currently enrolling participants aged 13-17 years with schizophrenia and participants aged 10-17 years with bipolar I disorder who are having an inadequate response to their current medication.

There are prohibited medications including other antipsychotics (besides the study medications), systemic steroids, monoamine oxidase inhibitors or medications prescribed for diabetes and/or weight loss.

Contact
Megan Kirkwood
(936) 206-8619
megan.kirkwood@iqvia.com

Deadline for Enrollment
6/30/2026


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

 

Online Study about in-the-moment Unusual Experiences

Do you have unusual thoughts, feelings, or experiences?

Have you been diagnosed with schizoaffective disorder, bipolar disorder or depression with psychosis?

You are invited to participate in an online research study about your experiences. This study is completed entirely online via video-call (Zoom). You will complete a clinical interview and assessments where a researcher will ask you questions about your mental health and social experiences, as well as 2 self-report questionnaires about how you’re feeling and your background. This study is a single session that will take approximately 1.5-3 hours. Compensation ($10/hour in Amazon gift cards) will be provided for participation.

You may be eligible to participate in this study if:

1) You are at least 18 years old

2) You regularly have unusual experiences or have been diagnosed with a mood disorder with psychosis

3) You currently live in the US

4) English is your primary language.

Contact
Elyssa Barrick
216-673-3363
emb261@case.edu

Trial Enrollment Closing Date: 6/30/2025

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

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