Actively Recruiting
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 With Current Mania or Mixed Features
Led by Neurocrine Biosciences · Updated on 2026-03-24
150
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of NBI-1117568 compared with a placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing a manic episode, with or without mixed features. The study is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Neurocrine Biosciences. It focuses on adults between 18 and 65 years old, including those with or without psychotic symptoms who require inpatient hospitalization. Participants are randomly assigned to receive either NBI-1117568 or a matching placebo, both given orally. The study monitors the changes in manic symptoms over a 21-day period. The trial includes careful assessment of safety and how the body processes the drug alongside measuring its effectiveness in reducing mania. During the study, participants will be regularly evaluated using specific rating scales to measure mania severity and overall clinical impression. The primary outcome is the change in the Young Mania Rating Scale (YMRS) total score from the start of the study to day 21. Secondary measures include changes in the Clinical Global Impression-Severity Scale (CGI-S). Safety monitoring and pharmacokinetic assessments will also be conducted. Participants' involvement lasts for at least 21 days, with ongoing monitoring to assess treatment effects and safety.
CONDITIONS
Brief 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 one prior manic episode requiring treatment.
- Participant is currently experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.
- Participant is aged between 18 and 65 years.
You will not qualify if you...
- Presence of any unstable or poorly controlled medical condition or chronic disease that may affect study participation or results.
- History of malignancy within 90 days before the start of screening.
- Primary diagnosis is not bipolar I disorder.
- History of clozapine treatment for treatment-resistant psychosis.
- Psychiatric hospitalization(s) lasting 30 or more consecutive days during the 90 days before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 21 days
Participants receive either NBI-1117568 or placebo by oral administration to treat acute manic episodes or manic episodes with mixed features in bipolar I disorder.
Baseline visit and 1 follow-up visit
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
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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