An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Recruiting · NCT07288320 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurocrine Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
NBI-1117568Placebo
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
9 locations listed across 8 US states.
- Neurocrine Clinical Site - Little Rock, Arkansas, United States
- Neurocrine Clinical Site - Garden Grove, California, United States
- Neurocrine Clinical Site - San Diego, California, United States
- Neurocrine Clinical Site - Hollywood, Florida, United States
- Neurocrine Clinical Site - Atlanta, Georgia, United States
- Neurocrine Clinical Site - Gaithersburg, Maryland, United States
- Neurocrine Clinical Site - Marlton, New Jersey, United States
- Neurocrine Clinical Site - Staten Island, New York, United States
- Neurocrine Clinical Site - Austin, Texas, United States