Understanding the impact of mood disorders and treatment responses
Natural History of Depression, Bipolar Disorder and Suicide Risk
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06462196 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unstable medical conditions or those who are pregnant may not benefit from this study.
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 performed: Other studies have shown promise in identifying predictors of treatment response in mood disorders, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth D Ballard, Ph.D. — National Institute of Mental Health (NIMH)
- Study coordinator: Kelly T Hurst, Ph.D.
- Email: moodresearch@mail.nih.gov
- Phone: (877) 646-3644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.