Omega-3 and Therapy Study for Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Supplement and No PEP

Will receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Omega-3 and PEP

Omega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily.

Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment.

Group Type EXPERIMENTAL

Omega-3 Supplementation

Intervention Type DRUG

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.

Psychoeducational Psychotherapy (PEP)

Intervention Type BEHAVIORAL

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.

Omega-3 and No PEP

Omega-3 Supplementation will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3)by mouth, two times daily.

Group Type EXPERIMENTAL

Omega-3 Supplementation

Intervention Type DRUG

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.

Placebo Supplement and PEP

Placebo Supplement will receive two capsules by mouth, two times daily matched for odor and appearance with the active intervention.

Psychoeducational Psychotherapy (PEP)Therapy sessions occur twice a week for up to 24 sessions of manualized treatment.

Group Type EXPERIMENTAL

Psychoeducational Psychotherapy (PEP)

Intervention Type BEHAVIORAL

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.

Interventions

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Omega-3 Supplementation

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.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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Omega Brite IF-PEP Pbo

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No