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 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
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
Recurrence Markers, Cognitive Burden and Neurobiological homeostasis in Late-Life Depression (REMBRANDT)
Volunteers who are eligible can help with a research study at The University of Illinois at Chicago that is examining why depression returns or how we can best predict who is at highest risk of depression returning.
The study is looking for 3 types of volunteers:
• People currently experiencing symptoms of depression,
• People who have been successfully treated for depression within the past 3 months i.e., you have been experiencing an improvement in symptoms from depression in the past 3 months
• People with no lifetime history of depression
Participants who are currently experiencing symptoms of depression will partake in 2-5 online or in-person visits at The University of Illinois at Chicago over approximately 8-20 weeks. Participation includes clinical interviews and a depression treatment plan using FDA-approved antidepressant medications.
Participants who have been successfully treated for depression or have no lifetime history of depression will join a second study phase which lasts for 2 years and involves 5-8 online or in-person visits at The University of Illinois at Chicago, 6-9 phone calls, brain MRIs, memory testing, and at-home assessments.
Participants will receive up to $160 for their time spent in the first phase of the study and up to $896-1016 for completing the second phase of the study. More information: https://www.redcap.ihrp.uic.edu/surveys/?s=D4NKRNXMWF
Eligibility
- Are age 60 or above
- Have no other mental health problems, other than anxiety
- Are able to have MRI scans
Contact
Camryn Gill and Angie Georgaras
312-996-0711
rembrandt@uic.edu
Deadline for Enrollment
01/15/2023
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
Phone: 734-647-6249
Email: 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
Project STAND
- Project STAND: Self-guided Treatment for Adolescents Navigating Depression
The goal of this virtual study is to test whether a 5-week self-guided mobile app utilizing cognitive behavioral therapy (CBT) can be a helpful treatment option for adolescents with symptoms of depression. We are currently welcoming teens (13-17 years old) and their caregivers to schedule a virtual session with a Limbix team member. During this session, they will have the opportunity to learn about the study, check eligibility, and provide consent to participate. Once enrolled, participants will download an app to use for 5 weeks at home. The app may or may not include the CBT-based treatment. Participants who do not receive the treatment will download an app to complete questionnaires. There will be no treatment content in this app. All participants and their caregivers will complete brief questionnaires before, during, and after the 5 week period with additional follow-up questionnaires a month after completion. Participation is compensated up to $150 in gift cards for teens for completing the study and $25 for caregivers for attending the virtual session.Eligibility
- Self-reported symptoms of depression as assessed at eligibility screening
- English fluency and literacy (participant and caregiver)
- Access to a compatible smartphone (or other device) and operating system (capable of installing the app from the Google Play or Apple App Store; list will be provided on study website) and regular internet access
- Participant willing and able to provide informed consent/assent and have legal guardian/caregiver willing and able to provide informed consent (if required)
- Under the care of a United States (U.S.)-based licensed healthcare provider and willing to provide contact information for the provider and sign a HIPAA release that allows Limbix to contact provider
- Willing and able to provide information required for study enrollment
- Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the study period (about 9 weeks after eligibility screening)
Restrictions Include:
- Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
- Participation in any other clinical research involving a mental health intervention or treatment within 60 days prior to eligibility screening
- Having a sibling in the study
Contact
Project-STAND
Email: project-stand@limbix.com
Call: (650) 489-6486
and/or visit: https://project.limbix.com/project-stand and https://clinicaltrials.gov/ct2/show/NCT05462652
Deadline for Enrollment
01/31/2023
Attitudes and Concerns toward the use of TMS in Depressed Adolescents
Pennsylvania State University and Dr. Laura Cabrera are leading an effort to examine adolescents and parental attitudes toward the use of repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) in adolescent depression.The attitudes and concerns of adolescents and their parents are important as they can influence the uptake of the interventions, with adolescents playing an important role in assenting to the intervention, and parents consenting to treatment. As TMS research and use continue to expand in this population, an enhanced understanding of the views and concerns of the use of TMS in young patients and their parents will provide a critical and timely perspective on the responsible use of this neuropsychiatric intervention and inform future study designs.This project aims to:1. Examine the attitudes and ethical concerns regarding rTMS and TBS among adolescents with depression2. Characterize the attitudes of their parents3. Compare the attitudes and ethical concerns for rTMS and for TBS among users and their parentsResearchers will conduct semi-structured interviews with 20 adolescents (12-17 years old) with depression and one of their parents. Interviews will be carried out separately. We are currently recruiting depressed adolescents and their parents. Parents and their children will receive a $50 e-gift card for their participation.
Eligibility
- Parent of an adolescent (age 12-17) living with depression
- Able to participate in an approximately 1-hour Zoom or phone interview
Contact
Laura Cabrera, MA, PhDAssociate Professor, NeuroethicsEmail: TMS_Ethics@psu.eduCall: (814) 863-2092
Deadline for Enrollment
09/01/2023
Bipolar Studies
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
Understanding bipolar disorder symptom-related spending behaviors and the acceptability of banking data-based interventions to support financial well-being and decision-making
This is a survey study to understand spending behaviors that occur during different mood episodes of bipolar disorder and patients’ acceptability of using banking data to develop an intervention system to help improve financial decision-making.
In this survey, you will be asked about your finances, financial decisions, and spending behaviors during different mood episodes of bipolar disorder.
Your participation in this research is confidential. The survey does not ask for any information that would identify you as a respondent. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared because your name is in no way linked to your responses. Your confidentiality will be safe to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties.
Eligibility
To participate in this study, you must be 18 years of age or older and have been diagnosed with bipolar disorder (any type).
Contact
Johnna Blair
814-706-8412
jlb883@psu.edu
Deadline for Enrollment
12/01/22
Learn more about participating in the study
Try a new app for bipolar disorder – PolarUs
The CREST.BD research network has just launched a research study evaluating the impact of a new app for bipolar disorder – PolarUs.
The first of its kind, the PolarUs app helps people with bipolar disorder to measure and monitor their quality of life and apply science-based self-management strategies, with the goal of guiding them towards health and quality of life. Funded by the Canadian Institutes of Health Research and philanthropic support from the Daymark Foundation, PolarUs represents the culmination of a decade of work by CREST.BD.
Eligibility
- Have a diagnosis of bipolar disorder
- Live in North America
- Are over age 18
- Have regular access to a smartphone (iOS 13/Android 10 or later)
People who are currently experiencing psychosis or active suicidal ideation may not be eligible to join this pilot study.
More details: crestbd.ca/polarus-app-study / team@polarus.app
Contact
PolarUs research team
Contact Phone: 604-822-7247
Contact Email: team@polarus.app
Deadline
12/31/2022
Learn more about participating in the study
Energy Metabolism Markers of Cognitive Function in Early Psychosis and Risk
There is evidence that glucose and insulin signaling is impaired in people who experience psychosis, including when psychotic symptoms first occur. People who experience psychosis can often have cognitive symptoms as well. This study will investigate if insulin signaling is related to cognition and illness outcomes in patients who’ve experienced psychosis for the first time in the past 3 years, as well as their siblings, and healthy adults.
This study will see if insulin signaling and other metabolic measures are related to disease progression in early psychosis, including cognitive symptoms, and to what degree this relationship might be present in patients’ healthy siblings.
Participants will complete 3-4 visits at Baseline, one follow-up visit at 6 months, and one follow-up visit at 12 months. Some of these visits may be done remotely. Participants will receive up to $635 for completion of the study and reimbursement of travel costs up to $50 per study visit. Study procedures include clinical interviews, 2 MRI scans, a metabolic assessment, blood draws, and cognitive assessments.
Eligibility
- Men and women between the ages of 18 and 35 years old.
- Siblings: Full siblings of patients who are not currently taking medications for a psychiatric condition. Siblings may have a psychiatric diagnosis, so long as they are not diagnosed with a disorder involving psychosis or are on any psychiatric medications.
- Patients: Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, other specified/unspecified schizophrenia spectrum or other psychotic disorder, or bipolar disorder with psychotic features, who first experienced psychosis in the past 36 months.
- Who can not participate: People with history of significant medical or neurologic illness (including diabetes mellitus); significant head trauma; pregnancy; or contraindication to MRI scan (including claustrophobia and metal implants); non-psychotropic medications known to influence glucose metabolism (including steroids, oral hypoglycemic agents, insulin, weight loss agents); history of ECT (electroconvulsive therapy) in the past 3 months.
Contact
Margaret Atkinson-Barnes
Trial Web Information:
https://rally.massgeneralbrigham.org/study/inergy
City/State the trial will take place: Belmont, MA
Phone: 617-855-2759
Email: matkinson-barnes@partners.org
Deadline for Enrollment
06/09/2023
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
Lithium Effects on the Brain’s Functional and Structural Connectome in the Treatment of Bipolar Disorder (Cleveland, OH)
Study participation will include 12 office visits across 26 weeks. The purpose of this study is to investigate and map the functional effects of lithium treatment on the nervous system in patients who have bipolar disorder. Lithium is FDA approved and highly effective in the treatment of bipolar disorder. However, despite decades of research, its clinical mechanism of action remains unclear. To conduct this study, a functional MRI will be used to measure brain activity by detecting changes associated with blood flow at four time points across the 26 weeks. All participants must be willing to be treated with only Lithium as a single mood stabilizer for six months. No other psychotropic medications may be taken during the duration of the study. All participants will be compensated for their time of participation in the study. Also seeking healthy volunteers with no history of a mood disorder.
Eligibility
- Ages 18-60 years (inclusive) and able to give voluntary informed consent
- Meeting diagnostic criteria for Bipolar Disorder type I or II, current Depressive Episode
- Not currently (hypo)manic
- No psychotropics in the last two weeks (if previously on fluoxetine then medication free for five weeks)
- No lithium treatment for past six months
- Ability to undergo an MRI scan
- No significant suicidal or homicidal ideation or gross disability
- Exclusion criteria for Bipolar Disorder subjects are:
- Meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as a primary diagnosis
- Requiring inpatient treatment
- Meeting DSM-V criteria for substance dependence within the past year, except caffeine or nicotine
- Positive urinary toxicology screening at baseline
- Use of alcohol in the past one week
- Serious medical or neurological illness
- Current pregnancy or breastfeeding
- Metallic implants or other contraindications to MRI.
- Participants must be currently depressed and not on any medications or treatments for their depression leading up to the MRI.
There is no experimental medication involved. All participants are prescribed Lithium, an FDA approved mood stabilizer and will be followed up and treated for a six-month time period.
Contact
Amy Morrison or Lauren Patterson
Phone: 216-445-2378 or 216-636-1675
Email: moodres@ccf.org
Deadline for Enrollment
October 2022
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
www.AlexianResearch
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
