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Psych Congress  

Lurasidone in Bipolar Depression: Early Improvement and Conditional Probability of Response

Authors  
Joyce Tsai, PhD
Mauricio Tohen, MD, DrPH, MBA
Hans Kroger, MPH, MS
Andrei Pikalov, MD, PhD
Antony Loebel, MD
Sponsor  
Sunovion Pharmaceuticals Inc.

Objective: To evaluate the conditional probability of responding at 6 weeks given lack of early improvement at weeks 1-3. Methods: Patients with bipolar I depression were randomized, in 2 double-blind trials, to 6 weeks of monotherapy with lurasidone (20-60 mg/d or 80-120 mg/d) vs. placebo (N=505); or with lurasidone (20-120 mg/d) vs. placebo adjunctive with lithium or valproate (N=346). Response was defined as ≥50% improvement in the Montgomery-Asberg Depression Rating Scale (MADRS). Improvement was defined as ≥25% (but <50%) improvement in the MADRS. Results: For combined lurasidone doses in the monotherapy study, ≥25% improvement at weeks 1, 2, and 3 was 14.9%, 31.1%, and 33.4%, respectively; week 6 response rate was 59.7%; and <25% improvement at weeks 1, 2, and 3 was associated with achieving a week 6 response in 53.7%, 40.3%, and 25.8%, respectively. The likelihood of week 6 response, after initial non-improvement by week 3, was greater for the 20-60mg/d group (32.0%) than for the 80-120mg/d group (18.0%). For lurasidone in the adjunctive therapy study, ≥25% improvement at weeks 1, 2, and 3 was 12.8%, 30.3%, and 12.8%, respectively; week 6 response rate was 64.1%; and <25% improvement at weeks 1, 2, and 3 was associated with a week 6 response in 54.2%, 41.3%, and 12.2%, respectively. Conclusions: Lack of improvement by week 3 is a potentially important predictor that may guide treatment decisions. For lurasidone doses of 20-60 mg/d, ~1/3 of patients become responders at week 6 without early improvement, and thus may benefit from continued treatment.

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