The Effect of Fish Oil in Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Department of Health
Information provided by:
National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT00816322
First received: December 31, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

The whole three-year study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status.

The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.


Condition Intervention
Major Depressive Disorder
Dietary Supplement: Omega-3 fatty acids
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fish Oil in Major Depressive Disorder: a Double-Blind Placebo-Controlled Monotherapy Trail to Demonstrate the Therapeutic and Preventive Effects of Depression

Resource links provided by NLM:


Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • HRSD [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BDI [ Designated as safety issue: No ]
  • Adverse effects [ Designated as safety issue: Yes ]
  • Recurrence rate [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: January 2005
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: omega-3 fatty acids Dietary Supplement: Omega-3 fatty acids
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV criteria for major depressive disorder.
  2. Age being age 18-65.
  3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

  1. Any major medical illnesses.
  2. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816322

Locations
Taiwan
China Medical University
Taichung, Taiwan, 404
Sponsors and Collaborators
National Science Council, Taiwan
Department of Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00816322     History of Changes
Other Study ID Numbers: DMR93-IRB-87
Study First Received: December 31, 2008
Last Updated: December 31, 2008
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014