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Cariprazine in the treatment of acute mania in bipolar I disorder : a double-blind , placebo-controlled , phase III trial . BACKGROUND This Phase III , randomized , double-blind , placebo-controlled study investigated the efficacy and tolerability of flexibly-dosed cariprazine in patients with acute manic or mixed episodes associated with bipolar I disorder . METHODS Patients were randomized to 3 weeks of double-blind treatment with cariprazine 3-12mg/day ( n=158 ) or placebo ( n=154 ) . The primary efficacy parameter was change from baseline to Week 3 in Young Mania Rating Scale ( YMRS ) total score . The secondary efficacy parameter was change from baseline to Week 3 in Clinical Global Impressions-Severity ( CGI-S ) score . RESULTS Mean change from baseline to Week 3 in YMRS total score was significantly greater for patients receiving cariprazine 3-12mg/day versus placebo ( P=0.0004 ) . Significant differences between groups in YMRS total score mean change were observed by Day 4 ( first postbaseline assessment ) and maintained throughout double-blind treatment ( all assessments , P < 0.01 ) . Cariprazine also demonstrated statistically significant superiority over placebo on YMRS response ( ≥50 % improvement : cariprazine , 58.9 % ; placebo , 44.1 % ; P=0.0097 ) and remission ( YMRS total score≤12 : cariprazine , 51.9 % ; placebo , 34.9 % ; P=0.0025 ) and mean change in CGI-S ( P=0.0027 ) score and Positive and Negative Syndrome Scale ( PANSS ) ( P=0.0035 ) total score . The most common cariprazine-related ( ≥10 % and twice placebo ) treatment emergent adverse events ( TEAEs ) were akathisia , extrapyramidal disorder , tremor , dyspepsia , and vomiting . Mean change from baseline in metabolic parameters were generally small and similar between groups . LIMITATIONS Lack of active comparator arm ; short duration of study . CONCLUSION In this study , cariprazine 3-12mg/day was effective and generally well tolerated in the treatment of manic and mixed episodes associated with bipolar I disorder .
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Intervention_Pharmacological
Cariprazine
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Intervention_Pharmacological
cariprazine
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Intervention_Pharmacological
cariprazine
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Intervention_Control
or placebo
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Intervention_Pharmacological
cariprazine
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Intervention_Pharmacological
Cariprazine
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Outcome_Other
efficacy and tolerability
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Outcome_Mental
Young Mania Rating Scale ( YMRS ) total score .
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Outcome_Mental
Clinical Global Impressions-Severity ( CGI-S ) score .
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Outcome_Mental
YMRS total score
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Outcome_Mental
YMRS response
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Participant_Condition
acute manic or mixed episodes associated with bipolar I disorder
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Participant_Condition
cariprazine 3-12mg/day
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Participant_Sample-size
n=158
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Participant_Sample-size
n=154