NCT07288320
Recruiting
Phase 2
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization
Neurocrine Biosciences6 sites in 1 country150 target enrollmentStarted: December 24, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
NBI-1117568
Experimental
Participants will receive NBI-1117568.
Intervention: NBI-1117568 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matching NBI-1117568.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
Time Frame: Baseline, Day 21
Secondary Outcomes
- Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21(Baseline, Day 21)
Investigators
Study Sites (6)
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