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Completed

NCT Number: NCT00816322

The Effect of Fish Oil in Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any major medical illnesses.
  • 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.

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

EPA 2.1 g/d+DHA 1.1 g/d

Placebo

Dietary Supplement

high oleic oil

Primary outcomes

  1. HAMD

    Time frame: W0 W2 W4 W8 W12

Secondary outcomes

  1. BDI

    Time frame: W0 W2 W4 W8 W12

  2. Adverse effects

    Time frame: W0 W2 W4 W8 W12

  3. Recurrence rate

    Time frame: M0 M1 M2 M3 M4 M6

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2009
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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