Clinical trial Recruiting at 1 site Observational Ages 18 to 120

Understanding the impact of mood disorders and treatment responses

Official title: Natural History of Depression, Bipolar Disorder and Suicide Risk

Run by National Institutes of Health Clinical Center (CC) · NCT06462196 · Data updated 2026-11-12

This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

More Suicide trials

Quick facts

Study typeObservational
Ages18 Years to 120 Years
SexAll
Enrollment500 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedSeptember 9, 2024
Main results expectedJune 1, 2030
Study endsJune 1, 2030
Registry record updatedNovember 9, 2026
Trial IDNCT06462196 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 18 and older who are currently receiving treatment for depression, bipolar disorder, or suicide risk.

Probably not a fit

Patients with unstable medical conditions or those who are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather systematic data on individuals receiving treatment for mood disorders, specifically depression and bipolar disorder, to better understand their experiences and responses to treatment. Participants, aged 18 and older, will undergo weekly interviews and questionnaires over a period of up to 12 weeks, with the possibility of extension based on treatment needs. The study focuses on identifying predictors of treatment response and biomarkers associated with antidepressant efficacy, utilizing clinical ratings and neurobiological assessments. The ultimate goal is to enhance treatment strategies and predict medication effectiveness for individuals at risk of suicide.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for mood disorders and better prediction of medication responses, potentially reducing suicide risk.

How similar studies have gone: Other studies have shown promise in identifying predictors of treatment response in mood disorders, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

* 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.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.