NBI-1117568 for adults with Bipolar I disorder experiencing current mania

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled trial compares NBI-1117568 to placebo in adults with Bipolar I disorder experiencing an acute manic episode, with or without mixed features. Participants receive either the experimental medication or a matching placebo and are monitored for changes in manic symptoms, safety, and drug levels over the treatment period. Key inclusion criteria require a primary diagnosis of Bipolar I with at least one prior manic episode; key exclusions include unstable medical conditions, prior clozapine for treatment-resistant psychosis, or extended recent psychiatric hospitalization. The study is conducted at Neurocrine Clinical Sites in California and includes regular clinic visits for symptom ratings and safety assessments.

Why it matters

Who can join: the full rules

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 symptoms.

Key Exclusion Criteria:

* Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
* Primary diagnosis is not bipolar I disorder.
* History of clozapine treatment for treatment-resistant psychosis.
* History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Where it's running

• Neurocrine Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Cerritos, California, United States Recruiting
• Neurocrine Clinical Site
  Garden Grove, California, United States Recruiting
• Neurocrine Clinical Site
  San Diego, California, United States Recruiting
• Neurocrine Clinical Site
  Hollywood, Florida, United States Recruiting
• Neurocrine Clinical Site
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.