Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.