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Psych Congress  

Categorical Improvement Across Mania Symptoms: Pooled Analyses of Cariprazine Phase II/III Randomized, Double-Blind, Placebo-Controlled Trials

Pauline Patrick, RPh
Suresh Durgam, MD
Stephen Zukin, MD
Kaifeng Lu, PhD
Adam Ruth, PhD
Marc Debelle, MD
Forest Laboratories, LLC, an affiliate of Actavis, Inc., and Gedeon Richter Plc

Cariprazine, a D3-preferring dopamine D3/D2 receptor partial agonist, has demonstrated efficacy in 3 positive Phase II/III clinical trials in patients with manic or mixed episodes associated with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668). This pooled post hoc analysis assessed clinically relevant symptom improvement in individual YMRS items. Pooled 3-week data (N=1037) from 3 double-blind, randomized, placebo-controlled trials of cariprazine (3-12 mg/d) were analyzed. The percentage of patients that shifted from at least moderate severity (YMRS item score ≥2 [items scored 0-4] and ≥4 [items scored 0-8]) at baseline to mild/no symptoms (score <2 [0-4 items] and <4 [0-8 items]) at Week 3 were determined for all 11 YMRS items. A significantly greater percentage of cariprazine versus placebo patients shifted from moderate or worse severity at baseline to mild/no symptoms at Week 3 on each YMRS single item. Odds ratios (OR) ranged from 1.6 (increased motor activity-energy) to 2.7 (irritability); all P<.001. Concurrent category shifts on all 4 YMRS core items (irritability, speech, content, and disruptive-aggressive behavior) were observed in a significantly greater percentage of cariprazine- (50.5%) versus placebo-treated (29.1%) patients (OR=2.43; P=.0002). The percentage of patients with mild/no symptoms on all 11 YMRS items at endpoint was also significantly higher in the cariprazine group (22.5%) compared with the placebo group (13.5%) (OR=1.85; P=.0004). Cariprazine demonstrated clinically meaningful categorical improvements on all individual YMRS items in this pooled analysis. These results suggest that cariprazine has efficacy across a broad spectrum of mania symptoms in patients with bipolar disorder.

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