Omega-3 and Therapy Study for Depression

Depression Clinical Trial

— OATS  

Official title:

Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341925
• Other study ID #: 2011H0033
• Secondary ID: 1R34MH085875-01A
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2011
• Last updated: March 4, 2016
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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 O3 fatty acids.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Omega-3 Supplementation
The O3 group will receive 1000 mg O3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other O3) two times daily for a total daily dose of 2000 mg O3 (1400 mg EPA: 200 mg DHA; 400 other O3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.

Behavioral:
• Psychoeducational Psychotherapy (PEP)
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center - Harding Hospital	Columbus	Ohio

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Depression Rating Scale - Revised (CDRS-R)	The CDRS-R is a severity scale for depression in children ages 6-17. It has 21 items, each rated on a 1-5 or 1-7 point scale in the direction of increasing severity. Scores can range from 17 to 113, demonstrated to correlate significantly with clinical global ratings of depression and to differentiate clinically defined groups of children. Interrater reliability is adequate (r =.86), as is test-retest reliability over a 4 week interval (r =.81; Poznanski et al, 1984). The CDRS-R will be completed at screen to determine clinical impairment of depressive symptoms necessary for study eligibility and at each subsequent assessment to determine clinical response.	Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization	Yes
Secondary	K-SADS Depression Rating Scale (KDRS)	Depressive symptom severity for worst past episode(s) and current episode (past two weeks) will be assessed using the KDRS at the assessment visits. The KDRS is a 12-item semi-structured interview with depression symptoms rated on a 6-point scale from none to severe. The KDRS has been shown to be a reliable measure of symptom severity.	Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization	Yes

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