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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.