Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response (SADFAT)

June 2, 2010 updated by: University of Virginia

Supplementation of Antidepressants With Fatty Acid Therapy

This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Psychiatry Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder.
  • Allowed comorbidities: Dysthymia, Anxiety Disorders.
  • 18 years old or older.
  • Males + Females.
  • English-speaking.
  • Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents.
  • Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study.
  • Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study.

Exclusion Criteria:

  • 2 or more failed trials of antidepressants (adequate dose and duration, and documented).
  • Substance dependence in the past 6 months.
  • Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial.
  • Psychosis.
  • Bipolar Affective Disorder Type I, II or NOS.
  • Pregnancy (current or planned).
  • Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion).
  • Dementia.
  • Mental retardation.
  • Traumatic Brain Injury.
  • History of Stroke.
  • History of seizure disorder.
  • Electroconvulsive therapy within past 6 months.
  • If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol.
  • Imminent risk for suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: One unsuccessful trial
Patients with one unsuccessful previous antidepressant trial
Dietary supplement: Omega-3 fatty acid
2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks
Drug: Bovine gelatin capsules
Bovine gelatin capsules that appear similar to active drug acting as placebo.
Active Comparator: One successful trial
Patients with one previous successful antidepressant trial
Dietary supplement: Omega-3 fatty acid
2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks
Drug: Bovine gelatin capsules
Bovine gelatin capsules that appear similar to active drug acting as placebo.
Active Comparator: No previous trial
Patients with no prior antidepressant therapy
Dietary supplement: Omega-3 fatty acid
2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks
Drug: Bovine gelatin capsules
Bovine gelatin capsules that appear similar to active drug acting as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Anita H Clayton, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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