Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

Exclusion Criteria

• •Young Mania Rating Scale (YMRS) total score \> 12
• •Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
• •Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
• •History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder
• •○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
• •History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
• •Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
• •Electroconvulsive therapy in the 3 months before Visit 1
• •Previous lack of response to electroconvulsive therapy
• •Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
• •Treatment with clozapine in a dose of \> 50 mg/day in the past 2 years
• •Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
• •Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
• •Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
• •Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
• •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• •Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
• •Known history of cataracts or retinal detachment
• •Known human immunodeficiency virus infection
• •Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center