Omega-3 and Therapy Study for Depression

Approximately 2 to 4% of children experience either major depressive disorder or dysthymic
disorder and 5 to 10% of children and adolescents experience subsyndromal depressive
symptoms (Birmaher et al). Due to its prevalence and association with significant
functioning deficits, childhood depression warrants treatment research. Treatments include
pharmacological and psychotherapeutic interventions. A recent meta-analysis 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). Research on treatment of mood disorders with Ω3 is promising
(Schacter et al, 2005); however, only one RCT has been conducted in children, which was
positive (Nemets et al, 2006). Findings from other clinical populations (ADHD, adolescent
depression, anxiety and pervasive developmental disorders in children) suggest combination
treatments are advantageous (Aman et al., 2009; The MTA Cooperative Group, 1999, 2004; The
TADS Team, 2007; Walkup et al., 2008). Little is known about the effectiveness of
psychotherapy for children age 12 and under who are clinically depressed. Researchers are
beginning to develop and test manual-based individual/family therapies for clinic-referred
children with diagnosable depression (Kovacs et al, 2006; Tompson et al, 2007); however, no
RCTs have been completed. Prior research supports incorporating psychoeducation about
depression, support, and skill building to decrease depressive symptoms (Birmaher et al).

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.

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.