Trials / Recruiting
RecruitingNCT07288320
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-1117568 | Oral administration |
| DRUG | Placebo | Oral administration |
Timeline
- Start date
- 2025-12-24
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2025-12-17
- Last updated
- 2026-03-24
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07288320. Inclusion in this directory is not an endorsement.