An observational study in Behavioral Symptoms, Suicide and Self-Injurious Behavior, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Mental Health (NIMH) · Observational
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.
People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.
This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.
Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.
Study Description:
This proposal would collect systematic data on individuals undergoing personalized treatments for depression, bipolar disorder and suicide risk within the Experimental Therapeutics and Pathophysiology Branch (ETPB). The ETPB recruits individuals with treatment-resistant mood disorders from around the country. After research participation, they are often offered a course of standard treatment, tailored to clinical needs, for clinical stabilization and discharge back to non-NIH clinicians. This protocol would allow for clinical ratings in-person and remotely throughout clinical standard treatments, as well as neurobiological procedures at baseline and study termination to identify potential clinical and demographic predictors and biomarkers of treatment response.
Objectives:
The primary objective is to identify predictors of antidepressant treatment response.
The secondary and tertiary objectives are to identify predictors of suicide ideation response to treatment, and biomarkers of antidepressant response to treatment, respectively.
Endpoints:
Primary Endpoint: Score on the Montgomery Asberg Depression Rating Scale
Secondary Endpoint: Score on the Scale for Suicidal Ideation
135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.
This study's planned enrollment of 500 is above the median of 360 across 15 observational studies indexed under Behavioral Symptoms.
Browse Behavioral Symptoms studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with depression, bipolar disorder, and individuals at elevated suicide risk.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with Bipolar Disorder
Individuals with Major Depressive Disorder
Individuals at an elevated suicide risk
Score on Montgomery Asberg Depression Rating Scale
Depression rating scale
Time frame: Weekly
Score on Scale for Suicide Ideation
Scale for rating suicide ideation
Time frame: Weekly
Plan to share: Yes — Clinical and research ratings, multi-modal MRI images, MEG scans, sleep studies, physiological, behavioral, and phenotypic data collected during the study, after deidentification.
Supporting information: Statistical analysis plan
Time frame: Starting within 1 year of completion of the study
Access criteria: Participants data will only be shared if they have opted into the data share agreement. Data deposited into repositories will not be subject to any access, distribution, or reuse limitation beyond the standard procedures of the repository. Data will be uploaded to repositories listed in our NIH Intramural Research Program (IRP) Data Management and Sharing Plan. There are no restrictions on subsequent access, distribution, or reuse once the data is placed in a repository. The Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IRB.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2030, 68 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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