Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder

April 29, 2016 updated by: Robert McNamara, University of Cincinnati

Evaluation of Omega-3 Fatty Acids as a Treatment-adjunct in Adolescent Patients With Major Depressive Disorder Exhibiting Partial Response to SSRI Medications: An Open-label Neuroimaging Trial

The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD.

The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a 10-week open-label EPA+DHA treatment trial in adolescent (aged 12-18 years) patients with major depressive disorder exhibiting partial response to SSRI medications. After a screening visit, patients were randomized (stratified by gender) to open-label fish oil supplements at a fixed dose of either 2.4 g/day or 15 g/day (2 tablespoons/day) for 10 weeks.

A physical examination, a complete blood count (CBC), and thyroid stimulating hormone (TSH) levels were determined at baseline and Week 10, and vital signs (pulse, blood pressure, weight, height, body mass index, temperature) were obtained at each visit. At each visit, safety and tolerability were assessed using a structured side effect interview, the Side Effects Form for Children and Adolescents.

At baseline and all weekly visits, depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), a 17-item observer-rated questionnaire, and remission was defined as a CDRS-R score of ≥28. If a patient's depressive symptoms worsened over the course of the trial (defined as 30% worsening relative to baseline on two consecutive visits using CDRS-R scores), they were withdrawn from the study. In view of the potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation, manic symptom severity was monitored over the course of the trial with the Young Mania Rating Scale (YMRS), an 11-item observer-rated questionnaire.

fMRI scans were performed at baseline and at 10 weeks.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

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
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criterion:

  • Between the ages of 12-18 years.
  • Diagnosis of MDD and not exhibited symptom remission CDRS-R (> 28 but < 40) despite being administered a standard therapeutic dose of an SSRI continuously for a minimum of 6 weeks.
  • Ability and willingness to provide assent and informed, written consent from at least one biological parent.
  • Present with biological parent or legal guardian.
  • Willingness to maintain current dietary habits.
  • Permission from treating physician
  • Able to perform fMRI/MRS.

Exclusion Criterion:

  • Inability or unwillingness to provide consent.
  • Antecedent or concurrent serious medical illness.
  • Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
  • History of seizures, excluding febrile seizures in childhood.
  • Patients requiring treatment with any drug which might obscure the action of the study treatment.
  • Female patients who are either pregnant or lactating.
  • Clinically significant laboratory abnormalities in the last year on CBC or TSH tests.
  • Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within the past 6 months, or a baseline CDRS-R suicide score of >3).
  • Hospitalized within the last 3 months
  • Greater than 1 year outside appropriate age/grade level
  • Pacemaker
  • Cerebral aneurysm clip
  • Cochlear implant
  • Metal fragments lodged within the eye or braces
  • Claustrophobia
  • Necessity of sedation (no sedation will be given).
  • History of loss of consciousness > 10 minutes in duration
  • Allergy to seafood.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose Fish Oil
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Drug: Low Dose Fish Oil
Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Other Names:
  • OmegaRx - Zone Laboratories
Experimental: High Dose Fish Oil
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Drug: High Dose Fish Oil
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Other Names:
  • OmegaRx - Zone Laboratories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood Symptoms Ratings
Time Frame: 10 weeks
Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)
10 weeks

Collaborators and Investigators

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

Sponsor

University of Cincinnati

Collaborators

The Inflammation Research Foundation

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

August 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • McNamara Omega3 MDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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