An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Recruiting
Phase 2
Interventional Study
Bipolar I Disorder
Mania
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 …
Contacts