Description
Inclusion Criteria:
- The main inclusion criteria include but are not limited to the following:
- * Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
- * History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
- * Body mass index is 18 and 40 kg/m\^2, inclusive.
- * If currently taking an antipsychotic, is able to discontinue it's use at least 5 days prior to study start and the duration of the study.
Exclusion Criteria:
- The main exclusion criteria include but are not limited to the following:
- * Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- * Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
- * History of cancer (malignancy).
- * Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
- * History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
- * Substance-induced psychotic disorder or behavioral disturbance.
- * DSM-5 TR defined substance use disorder within 3 months of screening.
- * History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
- * Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
- * Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
- * Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.
Ages Eligible for Study:
18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No