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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511810
• Other study ID #: McNamara Omega3 MDD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 3, 2007
• Last updated: December 3, 2014
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: December 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Low Dose Fish Oil
Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
• High Dose Fish Oil
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	The Inflammation Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No