An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

• NBI-1117568 (Drug): Oral administration
• Placebo (Drug): Oral administration

Primary outcomes

• Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21 [Baseline, Day 21]

Secondary outcomes

• Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21 [Baseline, Day 21]

Sex: All, ages: 18 Years to 65 Years

Key Inclusion Criteria:

* Participant has a primary diagnosis of bipolar I disorder.
* The participant has had at least 1 prior documented manic episode that required treatment.
* The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.

Key Exclusion Criteria:

* Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
* Primary diagnosis is not bipolar I disorder.
* History of clozapine treatment for treatment-resistant psychosis.
* History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

• Clinical Development Lead, Study director, Neurocrine Biosciences