Clinical Trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression (RGH-MD-53)

The purpose of this study is to investigate the safety and efficacy of the study drug in the treatment of bipolar I depression. The study drug has been approved by the U.S, Food and Drug Administration (FDA) for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder.


To be considered for participation into the study you must:
• be at least 18 and no more than 65 years of age at Visit 1
• give written informed consent
• have a diagnosis of bipolar I depression
• not have participated in a clinical research study in the past 6 months


The duration of the study will be approximately 9 weeks. During this period of time there will be about 7 visits.




PI: Steven Dubovsky, MD

Contact Information

Name: Sevie Kandefer
Phone: 716-898-4038