An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Bipolar I Disorder, Mania
In brief
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.
Key facts
- Study ID
- NCT07288320
- Run by
- Neurocrine Biosciences
- People needed
- 150
- Starts
- 2025-12-24
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Neurocrine Clinical Site — Little Rock, Arkansas, United States (enrolling)
- Neurocrine Clinical Site — Garden Grove, California, United States (enrolling)
- Neurocrine Clinical Site — San Diego, California, United States (enrolling)
- Neurocrine Clinical Site — Hollywood, Florida, United States (enrolling)
- Neurocrine Clinical Site — Atlanta, Georgia, United States (enrolling)
- Neurocrine Clinical Site — Gaithersburg, Maryland, United States (enrolling)
- Neurocrine Clinical Site — Marlton, New Jersey, United States (enrolling)
- Neurocrine Clinical Site — Staten Island, New York, United States (enrolling)
- Neurocrine Clinical Site — Austin, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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