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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Dose Fish Oil
High Dose Fish Oil
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Sadness, Insomnia, Loss of appetite, Fatigue, Trouble thinking

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose Fish Oil

High Dose Fish Oil

Arm Description

Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)

Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Outcomes

Primary Outcome Measures

Mood Symptoms Ratings
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.)

Secondary Outcome Measures

Full Information

First Posted
August 3, 2007
Last Updated
April 29, 2016
Sponsor
University of Cincinnati
Collaborators
The Inflammation Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00511810
Brief Title
Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
The Inflammation Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Sadness, Insomnia, Loss of appetite, Fatigue, Trouble thinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Fish Oil
Arm Type
Experimental
Arm Description
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Arm Title
High Dose Fish Oil
Arm Type
Experimental
Arm Description
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Intervention Type
Drug
Intervention Name(s)
Low Dose Fish Oil
Other Intervention Name(s)
OmegaRx - Zone Laboratories
Intervention Description
Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Intervention Type
Drug
Intervention Name(s)
High Dose Fish Oil
Other Intervention Name(s)
OmegaRx - Zone Laboratories
Intervention Description
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Primary Outcome Measure Information:
Title
Mood Symptoms Ratings
Description
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.)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert McNamara, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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