Search / Trial NCT00001146

Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

Bipolar Disorder Clinical Trial Eicosapentaenoic Ethyl Ester Life Chart Methodology Mood Disorders Omega 3 Fatty Acid Rapid Cycling Treatment

ClinConnect Summary

The aim of this study is to examine the efficacy of omega-3 fatty acids in the form of eicosapentaenoic ethyl esters (EPA) - in the treatment of bipolar disorder. Omega-3 fatty acids are long-chain, polyunsaturated fatty acids found in plant and marine sources. There are preliminary data to suggest that omega-3 fatty acids may be efficacious in the treatment of mood disorders. Patients in our bipolar outpatient clinic will be at one of the five NIMH - Stanley Foundation Bipolar Network (the "Network") sites participating in this project. Subjects will be randomly assigned in a double-blind ...

Gender

ALL

Eligibility criteria

  • Patients must meet DSM-IV criteria for Bipolar Disorder, depressed, hypomanic/manic, or rapid-cycling type.
  • Patients must be competent to comprehend the purpose of the study and provide informed consent.
  • Patients must be at least 18 years old.
  • Patients enrolling in the bipolar depression component of the study must have a depression of sufficient severity to rate greater than or equal to 16 on the Inventory of Depressive Symptomatology-Clinician (IDS-C), or the clinician must decide there is a need to treat.
  • Patients enrolling in the bipolar hypomania/mania component of the study must have a hypomania/mania of sufficient severity to rate greater than or equal to 12 on the Young Mania Rating Scale or the clinician must decide that there is a need to treat.
  • Patients enrolling in the bipolar rapid cycling component of the study must have mood fluctuations meeting one or both of the above acute episode criteria in the past 3 months or show a pattern of ultra rapid cycling (4 or more episodes within a month) or ultradian cycling (cycling within a day on 4 or more days/week) on the NIMH-LCM.
  • Patients must not have a serious medical illness.
  • Patients must not have non-insulin dependent diabetes mellitus (NIDDM) or insulin-dependent diabetes mellitus (IDDM).
  • Patients must not have acute suicidal or homicidal ideation.

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials