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Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00361374
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Dietary Supplement: eicosapentaenoic acid
Dietary Supplement: docosahexaenoic acid
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eicosapentaenoic Acid (EPA)

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic Acid (DHA)

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day


Participant Flow:   Overall Study
    Eicosapentaenoic Acid (EPA)   Docosahexaenoic Acid (DHA)   Placebo
STARTED   66   65   65 
COMPLETED   51   50   53 
NOT COMPLETED   15   15   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects for analysis.

Reporting Groups
  Description
Eicosapentaenoic Acid (EPA)

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic Acid (DHA)

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day

Total Total of all reporting groups

Baseline Measures
   Eicosapentaenoic Acid (EPA)   Docosahexaenoic Acid (DHA)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   58   59   177 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.8  (12.5)   46.2  (11.8)   45.0  (12.1)   45.8  (12.5) 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   53   50   54   157 
>=65 years   7   8   5   20 
Gender 
[Units: Participants]
       
Female   38   32   35   105 
Male   22   26   24   72 
Region of Enrollment 
[Units: Participants]
       
United States   60   58   59   177 


  Outcome Measures

1.  Primary:   Score on a Depression Severity Rating Scale Over Eight Weeks   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was underpowered due to lower than expected recruitment. The high placebo response rate may have impeded signal detection. The n-3 preparations were not pure, but “enriched” for one n-3 or the other, and contained other FAs.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr David Mischoulon, Director of Research, Depression Clinical and Research Program
Organization: Massachusetts General Hospital
phone: 617-724-5198
e-mail: dmischoulon@partners.org



Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361374     History of Changes
Other Study ID Numbers: 2005P002337
5R01MH074085 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: April 3, 2014
Results First Posted: July 18, 2014
Last Update Posted: July 18, 2014