RECRUITING

Natural History of Depression, Bipolar Disorder and Suicide Risk

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Natural History of Depression, Bipolar Disorder and Suicide Risk

Quick Facts

Study Start:2024-09-09
Study Completion:2030-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06462196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers
  2. * Age 18 years or older
  3. * Able to provide informed consent
  4. * Able to read and write English
  1. * Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.
  2. * Pregnancy
  3. * Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.
  4. * 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.

Contacts and Locations

Study Contact

Kelly T Hurst, Ph.D.
CONTACT
(877) 646-3644
moodresearch@mail.nih.gov
Elizabeth D Ballard, Ph.D.
CONTACT
(301) 435-9399
elizabeth.ballard@nih.gov

Principal Investigator

Elizabeth D Ballard, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Elizabeth D Ballard, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2030-06-01

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2030-06-01

Terms related to this study

Keywords Provided by Researchers

  • Neurobiology
  • Suicide
  • Major Depressive Disorder
  • Bipolar Disorder
  • Biomarkers
  • Suicide Risk
  • Treatment Resistant Depression

Additional Relevant MeSH Terms

  • Behavioral 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