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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: The Inflammation Research Foundation

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.