The Effect of Fish Oil in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT00816322
First received: December 31, 2008
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

The whole 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: Prevention
Official Title: The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HAMD [ Time Frame: W0 W2 W4 W8 W12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BDI [ Time Frame: W0 W2 W4 W8 W12 ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: W0 W2 W4 W8 W12 ] [ Designated as safety issue: Yes ]
  • Recurrence rate [ Time Frame: M0 M1 M2 M3 M4 M6 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2005
Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omega-3 fatty acids
EPA 2.1 g/d+DHA 1.1 g/d
Dietary Supplement: Omega-3 fatty acids
EPA 2.1 g/d+DHA 1.1 g/d
Placebo Comparator: Placebo
high oleic oil
Dietary Supplement: Placebo
high oleic oil

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
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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
  More Information

Responsible Party: Kuan-Pin, Researcher, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT00816322     History of Changes
Other Study ID Numbers: DMR93-IRB-87 
Study First Received: December 31, 2008
Last Updated: April 13, 2015
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 23, 2016