The data shows that patients treated with olanzapine and fluoxetine capsules (OFC) not have fewer symptoms but also respond faster to the therapy than patients treated with lamotrigine.
In the double-blind seven-week trial, patients suffering from an acute episode of bipolar I depression were either treated with OFC or lamotrigine. Efficacy measures of improvement in both depressive and manic symptoms were assessed using the Clinical Global Impression Severity (CGI-S) as the primary outcome measure.
In the study, serious adverse events, including symptoms associated with mania, occurred more frequently in patients treated with lamotrigine. Non-serious adverse events occurred more frequently with OFC treatment, including somnolence, weight gain and dry mouth.
Lamotrigine is not indicated for the acute treatment of bipolar depression; rather, it is indicated for the maintenance of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
OFC is the first and only acute treatment approved by the FDA for the depressive phase of bipolar disorder, a notoriously difficult-to-treat condition that afflicts millions of Americans. OFC is not indicated for the treatment of bipolar mania or bipolar maintenance.