Actively Recruiting
Phase 2 Study of NBI-1117568 Versus Placebo in Adults With Bipolar I Disorder Experiencing Mania or Mixed Episodes
Led by Neurocrine Biosciences · Updated on 2026-07-31
150
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the drug NBI-1117568 to see how well it improves manic symptoms in adults diagnosed with bipolar I disorder who are currently experiencing a manic episode, with or without mixed features. This phase 2 trial compares the effects of NBI-1117568 to a placebo in adults aged 18 to 65 years. The study is designed to evaluate the treatments safety, effectiveness, and how the drug behaves in the body. Participants are randomly assigned to receive either oral NBI-1117568 or a matching placebo in a double-blind setup, meaning neither the participants nor the researchers know who receives which treatment. The study monitors changes in manic symptoms using standardized scales over a 21-day period. During this time, participants remain hospitalized as required by their clinical condition. Throughout the study, participants undergo assessments including symptom rating scales such as the Young Mania Rating Scale and the Clinical Global Impression - Severity Scale. Safety and pharmacokinetics are also monitored. Participation lasts through the 21-day treatment period, with evaluations at baseline and day 21 to measure changes in mania severity and other health indicators.
CONDITIONS
Brief Title
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Research Team
N
Neurocrine Medical Information Call Center
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
