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An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Study on NBI-1117568 for Bipolar I Disorder Mania Symptoms

Recruiting
18-65 years
All
Phase 2

Study Objective: This research is testing a new medicine called NBI-1117568 to see if it helps people with bipolar I disorder feel less manic. Mania is when someone feels super excited or has lots of energy. The study will compare this medicine to a placebo, which looks like medicine but doesn't have any active ingredients.

Who Can Join:
  • Adults who have been diagnosed with bipolar I disorder.
  • Must have had at least one manic episode that needed treatment before.
  • Should be experiencing a current manic episode, which might include feeling very excited or having mixed feelings.
Who Shouldn't Join:
  • If you have other serious health issues or diseases.
  • If bipolar I disorder is not your main diagnosis.
  • If you've been hospitalized for mental health reasons for more than 30 days recently.
Key Points:
  • Participants will be monitored for safety and effectiveness of the treatment.
  • Some participants will receive a placebo instead of the actual medicine.
  • It is important to check if you meet all the criteria before joining.
Study details
    Bipolar I Disorder
    Mania

NCT07288320

Neurocrine Biosciences

17 October 2026

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