Natural History of Depression, Bipolar Disorder and Suicide Risk

Major Depressive Disorder Clinical Trial

Official title:

Natural History of Depression, Bipolar Disorder and Suicide Risk

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462196
• Other study ID #: 10001874
• Secondary ID: 001874-M
• Status: Not yet recruiting
• Start date: June 26, 2024
• Est. completion date: June 1, 2030

Study information

• Verified date: June 13, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Kelly T Hurst, Ph.D.
• Phone: (877) 646-3644
• Email: moodresearch[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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....

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

• 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

• A current NIMH employee/staff or their immediate family member

• 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 blood draws and imaging procedures. 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

Related Conditions & MeSH terms

• Analgesics
• Anesthetics
• Behavioral Symptoms
• Bipolar Disorder
• Central Nervous System Depressants
• Depression
• Depression, Bipolar
• Depression, Unipolar
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Depressive Symptoms
• Ketamine
• Major Depressive Disorder
• Molecular Mechanisms of Pharmacological Action
• Neurotransmitter Agents
• Peripheral Nervous System Agents
• Physiological Effects of Drugs
• Self-Injurious Behavior
• Sensory System Agents
• Suicide
• Treatment Resistant Depression

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Montgomery Asberg Depression Rating Scale	Depression rating scale	Weekly
Secondary	Score on Scale for Suicide Ideation	Scale for rating suicide ideation	Weekly

External Links

•   NIH Clinical Center Detailed Web Page