An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Purpose
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.
Conditions
- Bipolar I Disorder
- Mania
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NBI-1117568 |
Participants will receive NBI-1117568. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matching NBI-1117568. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
