A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-Response to Treatment with Lithium or Divalproex Alone - RACE

Sunovion Pharmaceuticals Inc0 个研究点目标入组 340 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Provide written informed consent and is 18 to 75 years of age inclusive.
•2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed ( 4 weeks and less than 12 months) without psychotic features.
•3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
•4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
•5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
•6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
•7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

•1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
•2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
•3. Hospitalization for a manic or mixed episode within the past two months.
•4. Used investigational compound within past 6 months.
•5. Cinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

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