Lead Sponsor

Organon and Co

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Each participant must be at least 18 years of age
•Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
•Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
•Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
•Each participant must have discontinued the use of all prohibited psychotropic medications

•A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
•A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
•A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).