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History of Changes for Study: NCT01341925
Omega-3 and Therapy Study for Depression (OATS)
Latest version (submitted March 4, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 25, 2011 None (earliest Version on record)
2 July 19, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
3 January 4, 2012 Recruitment Status, Sponsor/Collaborators, Contacts/Locations, Study Status and Eligibility
4 July 2, 2012 Study Status and Eligibility
5 September 4, 2012 Study Status and Eligibility
6 September 18, 2012 Arms and Interventions, Outcome Measures, Conditions, Contacts/Locations, Eligibility, Sponsor/Collaborators and Study Status
7 March 21, 2013 Study Status
8 October 28, 2013 Study Status
9 September 23, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 January 21, 2016 Arms and Interventions and Study Status
11 March 4, 2016 Arms and Interventions, Study Status, Study Design and Oversight
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Study NCT01341925
Submitted Date:  April 25, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2011H0033
Brief Title: Omega-3 and Therapy Study for Depression (OATS)
Official Title: Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Depression
Secondary IDs: 1R34MH085875-01A2 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: April 2011
Overall Status: Not yet recruiting
Study Start: September 2011
Primary Completion: March 2014 [Anticipated]
Study Completion: August 2014 [Anticipated]
First Submitted: April 22, 2011
First Submitted that
Met QC Criteria:
April 25, 2011
First Posted: April 26, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 25, 2011
Last Update Posted: April 26, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Ohio State University
Responsible Party:
Collaborators: National Institute of Mental Health (NIMH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Childhood Depression
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Factorial Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo Supplement and No PEP Dietary Supplement: 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.
Other Names:
  • Omega Brite
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 Names:
  • IF-PEP
Experimental: Omega-3 and PEP Dietary Supplement: 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.
Other Names:
  • Omega Brite
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 Names:
  • IF-PEP
Experimental: Omega-3 and No PEP Dietary Supplement: 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.
Other Names:
  • Omega Brite
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 Names:
  • IF-PEP
Experimental: Placebo Supplement and PEP Dietary Supplement: 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.
Other Names:
  • Omega Brite
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 Names:
  • IF-PEP
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Childhood Depression Rating Scale - Revised (CDRS-R)
[ Time Frame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization ]

Secondary Outcome Measures:
1. K-SADS Depression Rating Scale (KDRS)
[ Time Frame: Week prior to randomization and then weeks 2, 4, 6, 9, and 12 post-randomization ]

Open or close this module Eligibility
Minimum Age: 8 Years
Maximum Age: 12 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. aged 8-12 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. psychosis
  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.
Open or close this module Contacts/Locations
Central Contact Person: Mary A Fristad, PhD
Telephone: 614-293-4572
Email: mary.fristad@osumc.edu
Central Contact Backup: Anthony T Vesco, BA
Telephone: 614-293-5486
Email: anthony.vesco@osumc.edu
Study Officials: Mary A Fristad, PhD
Principal Investigator
Ohio State University
L E Arnold, MD
Principal Investigator
Ohio State University
Locations: United States, Ohio
Ohio State University Medical Center - Harding Hospital
Columbus, Ohio, United States, 43210
Contact:Principal Investigator: Mary A Fristad, PhD
Contact:Principal Investigator: L E Arnold, MD, MEd
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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