Natural History of Depression, Bipolar Disorder and Suicide Risk

ConditionsBehavioral Symptoms Suicide Self-Injurious Behavior Sensory System Agents Analgesics Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Ketamine Depression, Unipolar Depressive Symptoms Treatment Resistant Depression Major Depressive Disorder Depression, Bipolar

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-120

SponsorNational Institute of Mental Health (NIMH)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

Not listed

Trial groups

500 Participants

are grouped into 3 trial groups

Sponsors and collaborators

National Institute of Mental Health (NIMH)

Lead sponsor

Source ClinicalTrials.gov