Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified

NCT01507753 | Completed Phase 1 DMC

• 2 other identifiers: 2011H01041R34MH090148-01A1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are, unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005; 2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood, which might provide either a primary or adjunctive treatment with a more favorable risk:benefit ratio for children suffering from BP-NOS than currently available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad, Verducci, Walters, \& Young, 2009); its efficacy in treating BP-NOS specifically has not been determined. The current study compares Ω3, PEP, and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.

Conditions

Bipolar Disorder

Keywords

childhood bipolar disorder

Outcome Measures

Primary Outcomes (1)

• Changes to K-SADS Mania Rating Scale (KMRS)

  This semi-structured interview contains 21 items that assess the severity of manic symptoms in children and adolescents. The KMRS shows high internal consistency (α = 0.94), sensitivity (0.87), and specificity (0.81) (Axelson et al., 2003). The KMRS will be administered at the assessment visits to determine worst lifetime and current (past two weeks) symptoms of mania.

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

Secondary Outcomes (1)

• Changes to 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)
• Has a diagnosis of BP-NOS according to the LAMS definition. Criteria as follows:
• Clinically significant bipolar symptoms that do not meet DSM IV TR criteria for bipolar disorder I or bipolar disorder II
• Elated mood plus 2 or more associated symptoms from DSM IV TR or irritable mood plus 3 or more symptoms
• A change in functioning, and a minimum duration of 4 hours within a 24-hour period and at least 4 cumulative lifetime days meeting criteria
• Full scale IQ ≥ 70
• Child and one parent or other caregiver must be able to complete all assessment
• Child must be able to swallow capsules (training in swallowing will be offered)
• Parent 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
• 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)
• Three or more symptoms rated as "marked" or "severe" on the KDRS or KMRS
• Concurrent mental health intervention (pharmacotherapy and/or psychotherapy) in the past month.

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

• Fristad MA, Young AS, Vesco AT, Nader ES, Healy KZ, Gardner W, Wolfson HL, Arnold LE. A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder. J Child Adolesc Psychopharmacol. 2015 Dec;25(10):764-74. doi: 10.1089/cap.2015.0132.

  PMID: 26682997 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• L. Eugene 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: August 12, 2011
• First Posted: January 11, 2012
• 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)