NCT07288320RecruitingPhase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With 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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 24 Dec 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Bipolar disorder
- NCT number
- NCT07288320
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 24 Dec 2025 to the primary completion date, Feb 2028
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Primary diagnosis is not bipolar I disorder.
- History of clozapine treatment for treatment-resistant psychosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cerritos | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Gaithersburg | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.