Omega-3 and Therapy Study for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Omega-3 Supplementation; Psychoeducational Psychotherapy (PEP); Placebo
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): The Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.; Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences.; The placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention.
Other intervention name(s): Omega Brite; IF-PEP; Pbo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood depression