Omega-3 fatty acids plus inositol may serve as a significantly beneficial therapy for children and adolescents with bipolar spectrum disorder, according to new phase 3 data.
In new research presented at The American Professional Society of ADHD and Related Disorders (APSARD) 2021 Annual Conference this weekend, a team of investigators from the Massachusetts General Hospital and Harvard Medical School reported significant improvements to bipolar disorder symptoms with monotherapy and combination use of fatty acids and/or inositol over 12 weeks.
Presented by Janet Wozniak, MD, associate professor of Psychiatry at Harvard Medical School, the findings could indicate a viable alternative therapy regimen for younger patients with the disorder.
Wozniak and colleagues sought to assess the efficacy, safety, and tolerability of omega-3 fatty acids and inositol as both monotherapies and in combination for treating pediatric bipolar spectrum disorder.
They referenced recent research suggesting inositol, a central nervous system-based carbocyclic sugar, plays a role in mood disorder pathophysiology. “Inositol is decreased in the cerebrospinal fluid of patients with depression and is involved in the second messenger system for numerous neurotransmitter receptors,” investigators wrote.
Their phase 3, 12-week, double-blind, controlled assessment of the therapies included patients aged 5-12 years old with diagnosed bipolar disorder. Patients were randomized to 3 different treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, or combination therapy.
A series of scales and tests were used to assess mania and depression symptoms associated with each treatment arm:
- Young Mania Rating Scale (YMRS)
- Hamilton Depression Rating Scale (HDRS)
- Children’s Depression Rating Scale (CDRS)
- Clinical Globe Impression (CGI) Severity (CGI-S) Scale
- CGI Improvement (CGI-I) Scale
At 12 weeks, investigators observed significant reductions in YMRS and HDRS mean scores from baseline in all 3 treatment arms. Mean CDRS scores were significantly reduced among young patients receiving omega-3 fatty acids plus placebo, but even more so among those receiving combination therapy.
The fatty-acid plus inositol treatment arm reported the greatest rates of anti-manic and antidepressant response at 30% and 50% reductions, respectively, in YMRS, HDRS, and CDRS scores. CGI-I mania and depression scores for the treatment are were ≤2 at endpoint, indicating significant improvement.
Overall, Wozniak and colleagues concluded the findings indicate promise for a trio of pediatric bipolar therapy options.
“Omega-3 fatty acids and inositol both alone and in combination may be effective safe alternative and natural treatment for pediatric BP spectrum disorder,” they wrote. “Furthermore, the combined treatment may be more effective than either treatment alone.”
The study, “A Randomized, Double-Blind, Controlled Clinical Trial of Omega-3 Fatty Acids and Inositol as Monotherapies and in Combination for the Treatment of Pediatric Bipolar Spectrum Disorder,” was presented at APSARD 2021.