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

Studying NBI-1117568 for adults with Bipolar I mania symptoms.

Recruiting
18-65 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests a new drug called NBI-1117568 to see if it helps adults with bipolar I disorder (a mental health condition causing extreme mood swings) who are currently in a manic episode (when someone feels very excited or irritable). Researchers want to find out if the drug reduces these manic symptoms compared to a placebo (a substance with no active medicine). Participants must have had at least one past manic episode needing treatment and be currently experiencing a manic episode, possibly with mixed features (a mix of manic and depressive symptoms).

  • Study involves taking either NBI-1117568 or placebo.
  • Participants must have bipolar I disorder with a current manic episode.
  • People with certain medical conditions or recent psychiatric hospitalizations cannot join.

Consider joining if you have bipolar I disorder and want to help find new treatments. Ensure no unstable medical conditions that might affect participation. This study requires you to take medication and attend study visits. Always talk to your doctor before joining a study.

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Study details
    Bipolar I Disorder
    Mania

NCT07288320

Neurocrine Biosciences

25 April 2026

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