The Effect of Fish Oil in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816322
• Other study ID #: DMR93-IRB-87
• Status: Completed
• Phase: N/A
• First received: December 31, 2008
• Last updated: April 13, 2015
• Start date: January 2005
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Dietary Supplement:
• Omega-3 fatty acids
EPA 2.1 g/d+DHA 1.1 g/d
• Placebo
high oleic oil

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD		W0 W2 W4 W8 W12	No
Secondary	BDI		W0 W2 W4 W8 W12	No
Secondary	Adverse effects		W0 W2 W4 W8 W12	Yes
Secondary	Recurrence rate		M0 M1 M2 M3 M4 M6	No