Omega-3 and Therapy Study for Depression

NCT01341925 | Completed Phase 1 DMC

• 2 other identifiers: 2011H00331R34MH085875-01A2
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

childhood depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• K-SADS Depression Rating Scale (KDRS)

  Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization

Study Arms (4)

Placebo Supplement and No PEP

PLACEBO COMPARATOR

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

Other: Placebo

Omega-3 and PEP

EXPERIMENTAL

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.

Drug: Omega-3 Supplementation; Behavioral: Psychoeducational Psychotherapy (PEP)

Omega-3 and No PEP

EXPERIMENTAL

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.

Drug: Omega-3 Supplementation

Placebo Supplement and PEP

EXPERIMENTAL

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.

Behavioral: Psychoeducational Psychotherapy (PEP)

Interventions

Omega-3 Supplementation 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.

Also known as: Omega Brite

Omega-3 and No PEP; Omega-3 and PEP

Psychoeducational Psychotherapy (PEP) 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.

Also known as: IF-PEP

Omega-3 and PEP; Placebo Supplement and PEP

Placebo 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.

Also known as: Pbo

Placebo Supplement and No PEP

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 7-14 years (boys and girls)
• DSM-IV-TR diagnosis of major depressive disorder and/or dysthymic disorder as determined by consensus conference
• Children's Depression Rating Scale (CDRS-R) score ≥ 40
• full scale IQ ≥ 70
• child and at least one parent must be able to complete all assessments
• child must be able to swallow capsules (training in swallowing will be offered)
• parent/guardian and child must be willing to have blood drawn from child at two study assessments.

You may not qualify if:

• major medical disorders (eg diabetes, epilepsy, metabolic disorder)
• inability to communicate in English
• lack of access via phone
• autism
• schizophrenia, or other psychotic states warranting anti-psychotic medication
• DSM-IV-TR diagnosis of a bipolar disorder
• 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)
• intake in the previous 4 weeks of supplemental Ω3 fatty acids.

Sponsors & Collaborators

• L. Eugene Arnold: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ohio State University Medical Center - Harding Hospital

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24.

  PMID: 29063592 DERIVED

• 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.

  PMID: 28379964 DERIVED

• 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.

  PMID: 27604240 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• L E Arnold, MD, MEd

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Mary A Fristad, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 26, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)