NBI-1117568 for adults with Bipolar I disorder experiencing current mania
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
This trial will test whether NBI-1117568 reduces manic symptoms in adults with Bipolar I disorder who are currently having a manic episode.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neurocrine Biosciences Industry-sponsored |
| Locations | 6 sites (Garden Grove, California and 5 other locations) |
| Trial ID | NCT07288320 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a primary diagnosis of Bipolar I disorder who are currently experiencing an acute manic episode (with or without mixed features) and who have had at least one prior treated manic episode.
Not a fit: People whose mood symptoms are due to another primary diagnosis, who have unstable medical or recent serious psychiatric conditions, or who previously required clozapine are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If effective, NBI-1117568 could reduce manic symptoms and offer a new treatment option for adults with Bipolar I disorder.
How similar studies have performed: This is a Phase 2 test of a novel compound; while some other novel agents for mania have shown mixed results, NBI-1117568 has not yet been established as effective in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Garden Grove, California and 5 other locations
- Neurocrine Clinical Site — Garden Grove, California, United States (Recruiting)
- Neurocrine Clinical Site — Hollywood, California, United States (Recruiting)
- Neurocrine Clinical Site — San Diego, California, United States (Recruiting)
- Neurocrine Clinical Site — Atlanta, Georgia, United States (Recruiting)
- Neurocrine Clinical Site — Gaithersburg, Maryland, United States (Recruiting)
- Neurocrine Clinical Site — Marlton, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Neurocrine Medical Information Call Center
- Email: medinfo@neurocrine.com
- Phone: 1-877-641-3461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.