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Natural History of Depression, Bipolar Disorder and Suicide Risk

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Questionnaires, Interviews, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the experience of treatment for depression, bipolar disorder, and suicide risk in adults age 18 or older. Researchers hope to learn which medicines may reduce thoughts of suicide. People in the study have weekly interviews and surveys, and may choose to have other tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You are receiving treatment for depression, bipolar disorder, or suicide risk.
  • You have enrolled in and signed consent for study 01-M-0254, which evaluates people with mood and anxiety disorders and healthy volunteers.
  • You can understand the study and agree to take part.
  • You can read and write English.

Who can't join

  • You have a medical condition that is not stable and, in the study doctor's view, would keep you from receiving care in or outside the hospital.
  • You are pregnant.
  • You joined study 01-M-0254 as a healthy volunteer.
  • In the past 3 months, you had a drug abuse, dependence, or use disorder involving drugs other than caffeine, nicotine, or cannabis (marijuana).
  • In the past 3 months, you had alcohol abuse or dependence, or a moderate to severe alcohol use disorder.
  • If you currently use drugs other than caffeine, nicotine, or cannabis, you used illegal or commonly misused drugs in the 2 weeks before agreeing to join.
  • You do not have a negative urine drug test before joining. Prescribed benzodiazepines or stimulants are allowed exceptions.
  • You use cannabis daily, cannot stop using it during the study, or a clinician finds that it gets in the way of your daily life.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MD