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

Completed · Phase 1 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID: NCT01507753
Run by: L. Eugene Arnold
People needed: 23
Starts: 2011-09-01
Expected to finish: 2014-09-01
Last updated by the study team: 2016-03-08

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Ohio State University Medical Center- Harding Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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