Actively Recruiting
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Led by Neurocrine Biosciences · Updated on 2026-03-24
150
Participants Needed
6
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a primary diagnosis of bipolar I disorder.
- Participant has had at least 1 prior manic episode requiring treatment.
- Participant is currently experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.
You will not qualify if you...
- Unstable or poorly controlled medical conditions or chronic diseases affecting participation.
- History of malignancy within 90 days before screening.
- Primary diagnosis other than bipolar I disorder.
- History of clozapine treatment for treatment-resistant psychosis.
- Psychiatric hospitalization for 30 or more consecutive days in the 90 days before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Neurocrine Clinical Site
Garden Grove, California, United States, 92845
Actively Recruiting
2
Neurocrine Clinical Site
Hollywood, California, United States, 33024
Actively Recruiting
3
Neurocrine Clinical Site
San Diego, California, United States, 92123
Actively Recruiting
4
Neurocrine Clinical Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
5
Neurocrine Clinical Site
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
6
Neurocrine Clinical Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
Research Team
N
Neurocrine Medical Information Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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