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

NCT00511810 | Completed Phase 2 Results DMC

• 1 other identifier: McNamara Omega3 MDD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Sadness; Insomnia; Loss of appetite; Fatigue; Trouble thinking

Outcome Measures

Primary Outcomes (1)

• 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.)

  10 weeks

Study Arms (2)

Low Dose Fish Oil

EXPERIMENTAL

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

Drug: Low Dose Fish Oil

High Dose Fish Oil

EXPERIMENTAL

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

Drug: High Dose Fish Oil

Interventions

Low Dose Fish Oil DRUG

Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)

Also known as: OmegaRx - Zone Laboratories

Low Dose Fish Oil

High Dose Fish Oil DRUG

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

Also known as: OmegaRx - Zone Laboratories

High Dose Fish Oil

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Cincinnati: lead
• The Inflammation Research Foundation: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders; Anorexia; Fatigue

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Results Point of Contact

• Title: Robert McNamara, PhD
• Organization: University of Cincinnati

robert.mcnamara@uc.edu

513-558-5601

Study Officials

• Robert McNamara, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 27, 2016
• Results First Posted: December 4, 2014

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)