Behavioral SymptomsNCT06462196
Natural History of Depression, Bipolar Disorder and Suicide Risk
An observational study of Behavioral Symptoms and Suicide, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Behavioral Symptoms, Suicide, Self-Injurious Behavior
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 1 Jun 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with depression, bipolar disorder, and individuals at elevated suicide risk.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers
- Age 18 years or older
- Able to provide informed consent
- Able to read and write English
Who cannot join
- Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.
- Pregnancy
- Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.
- Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Elizabeth Ballard, Ph.D., 301-435-9399, elizabeth.ballard@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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
- Conditions
- Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents
- Keywords
- Neurobiology, Suicide, Major Depressive Disorder, Bipolar Disorder, Biomarkers, Suicide Risk, Treatment Resistant Depression
- Medical subject headings
- Behavioral Symptoms, Suicide, Self-Injurious Behavior, Depressive Disorder, Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder | Individuals with Bipolar Disorder | |
| Major Depressive Disorder | Individuals with Major Depressive Disorder | |
| Suicide Risk | Individuals at an elevated suicide risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Montgomery Asberg Depression Rating Scale
Depression rating scale
Measured: Weekly
Secondary outcomes (1)
Score on Scale for Suicide Ideation
Scale for rating suicide ideation
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start9 Sep 2024
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth D Ballard, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462196
- Sponsor's protocol ID
- 10001874
- Other IDs
- 001874-M
- Status last verified
- 29 Sep 2026
- First submitted
- 14 Jun 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and research ratings, multi-modal MRI images, MEG scans, sleep studies, physiological, behavioral, and phenotypic data collected during the study, after deidentification.