Omega-3 and Therapy Study for Depression

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Childhood depression warrants treatment research; including pharmacological and psychotherapeutic interventions. A recent study found fluoxetine to be the only medication with empirical support for decreasing depression in children, but concerns about treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted interest in alternative therapies including dietary supplements such as omega-3 fatty acids (Ω3).

The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across an array of outcome variables, adherence to treatment, and side effects. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justifiable.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: L. Eugene Arnold
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

Inclusion Criteria:

1. aged 7-14 years (boys and girls)

2. DSM-IV-TR diagnosis of major depressive disorder and/or dysthymic disorder as determined by consensus conference

3. Children's Depression Rating Scale (CDRS-R) score ≥ 40

4. full scale IQ ≥ 70

5. child and at least one parent must be able to complete all assessments

6. child must be able to swallow capsules (training in swallowing will be offered)

7. parent/guardian and child must be willing to have blood drawn from child at two study assessments.

Exclusion Criteria:

1. major medical disorders (eg diabetes, epilepsy, metabolic disorder)

2. inability to communicate in English

3. lack of access via phone

4. autism

5. schizophrenia, or other psychotic states warranting anti-psychotic medication

6. DSM-IV-TR diagnosis of a bipolar disorder

7. active suicidal concern (e.g., "I want to kill myself", a plan for suicide, or an attempt in the past month; however, passive suicidal ideation, such as "I wish I were dead" would not exclude)

8. intake in the previous 4 weeks of supplemental Ω3 fatty acids.