Study Finds Olanzapine-Fluoxetine Combo Superior to Placebo for Bipolar Disorder in Children
Psychiatric News Alert|
A combination of the antipsychotic olanzapine and the antidepressant fluoxetine proved superior to placebo for acute treatment of bipolar I depression in patients aged 10-17 in a randomized control trial published online in the Journal of the American Academy of Child and Adolescent Psychiatry.
The double-blind study by researchers at Eli Lilly and Company randomized 170 young patients with bipolar I disorder experiencing an acute depressed episode to the olanzapine/fluoxetine combination (OFC) and 85 to placebo for up to eight weeks of treatment. The primary efficacy measure was mean change in the Children’s Depression Rating Scale-Revised (CDRS-R).
Baseline-to-week-8 least-squares mean change in CDRS-R score was greater for OFC-treated patients than for placebo-treated patients, with between-group differences statistically significant at week 1 and all subsequent visits. Rates of and times to response and remission were statistically significantly greater for OFC- than placebo-treated patients. The most frequent treatment-emergent adverse events in the OFC group were weight gain, increased appetite, and somnolence. Treatment-emergent hyperlipidemia was common among OFC-treated patients.
“OFC was superior to placebo and approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of bipolar I depression in patients 10-17 years of age. Benefits should be weighed versus the risk of adverse events, particularly weight gain and hyperlipidemia,” the researchers said.