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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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One unsuccessful trial

Patients with one unsuccessful previous antidepressant trial

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

Bovine gelatin capsules

Intervention Type DRUG

Bovine gelatin capsules that appear similar to active drug acting as placebo.

One successful trial

Patients with one previous successful antidepressant trial

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

Bovine gelatin capsules

Intervention Type DRUG

Bovine gelatin capsules that appear similar to active drug acting as placebo.

No previous trial

Patients with no prior antidepressant therapy

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

Bovine gelatin capsules

Intervention Type DRUG

Bovine gelatin capsules that appear similar to active drug acting as placebo.

Interventions

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Omega-3 fatty acid

2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Bovine gelatin capsules

Bovine gelatin capsules that appear similar to active drug acting as placebo.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No