Tests NBI-1117568 in adults with bipolar I disorder during a manic episode
Tests NBI-1117568 against placebo in adults having a manic episode of bipolar I disorder.
Plain-language title generated from the registry record
Registry title: An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Key facts
- Where
- Atlanta, Austin, Cerritos, Gaithersburg, Garden Grove, Hollywood, Houston, Little Rock, Marlton, San Diego, and Staten Island, United StatesSee the 11 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07288320, who can take part
Where in United States
- AtlantaAtlanta, United StatesTaking people
- AustinAustin, United StatesTaking people
- CerritosCerritos, United StatesTaking people
- GaithersburgGaithersburg, United StatesTaking people
- Garden GroveGarden Grove, United StatesTaking people
- HollywoodHollywood, United StatesTaking people
- HoustonHouston, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- MarltonMarlton, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- Staten IslandStaten Island, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT07288320
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Primary diagnosis is not bipolar I disorder; History of clozapine treatment for treatment-resistant psychosis.