Clinical trial NCT01341925: Omega-3 and Therapy Study for Depression
Official title: Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: childhood depression
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-04-26
Enrollment: 73
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Childhood Depression Rating Scale - Revised (CDRS-R)
timeFrame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization
Secondary outcomes:
measure: K-SADS Depression Rating Scale (KDRS)
timeFrame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center - Harding Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: L E Arnold, MD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Mary A Fristad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christian LM, Young AS, Mitchell AM, Belury MA, Gracious BL, Arnold LE, Fristad MA. Body weight affects omega-3 polyunsaturated fatty acid (PUFA) accumulation in youth following supplementation in post-hoc analyses of a randomized controlled trial. PLoS One. 2017 Apr 5;12(4):e0173087. doi: 10.1371/journal.pone.0173087. eCollection 2017.
citation: Young AS, Arnold LE, Wolfson HL, Fristad MA. Psychoeducational Psychotherapy and Omega-3 Supplementation Improve Co-Occurring Behavioral Problems in Youth with Depression: Results from a Pilot RCT. J Abnorm Child Psychol. 2017 Jul;45(5):1025-1037. doi: 10.1007/s10802-016-0203-3.