Rakesh Jain, Roger S McIntyre, Andrew J Cutler, Willie R Earley, Huy-Binh Nguyen, Julie L Adams, Lakshmi N Yatham
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引用次数: 0
Abstract
Post hoc analyses evaluated cariprazine, a dopamine D 3 -preferring D 3 /D 2 receptor partial agonist, in patients with bipolar I depression and high baseline anxiety. Data were pooled from two phase 3, randomized, double-blind, placebo-controlled studies in adults with bipolar I disorder and a major depressive episode (NCT02670538, NCT02670551). Cariprazine 1.5 and 3 mg/d were evaluated in patient subgroups with higher and lower baseline anxiety. In patients with higher baseline anxiety, significant differences for cariprazine 1.5 mg/d versus placebo were observed on change in Montgomery-Åsberg Rating Scale (MADRS) total score, Hamilton Anxiety Rating Scale (HAM-A) total score and subscale scores, and rates of MADRS remission ( P < 0.05 all); nonsignificant numerical improvements were observed for cariprazine 3 mg/d versus placebo. In patients with lower anxiety, differences versus placebo were significant for HAM-A (cariprazine 3 mg/d) and MADRS (cariprazine 1.5 and 3 mg/d) total score changes ( P < 0.05 all). Rates of treatment-emergent mania were low and similar for cariprazine and placebo. Cariprazine 1.5 mg/d had consistent effects on anxiety and depression symptoms in patients with bipolar I depression and higher baseline anxiety; tolerability was favorable. Given few proven treatments for this common comorbidity, these preliminary results are promising.
期刊介绍:
International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout psychopharmacology. It reports on studies in human subjects, both healthy volunteers and patients, which relate the effects of drugs on psychological processes.
A major objective of the journal is to publish fully refereed papers which throw light on the ways in which the study of psychotropic drugs can increase our understanding of psychopharmacology. To this end the journal publishes results of early Phase I and II studies, as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. Other topics covered include the epidemiology of psychotropic drug prescribing and drug taking, the sociology of psychotropic drugs including compliance, and research into the safety and adverse effects of these compounds.