Recruiting

Phase 2

NBI-1117568An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Sponsor:

Neurocrine Biosciences

Code:

NCT07288320

Conditions

Bipolar I Disorder

Mania

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NBI-1117568

Placebo

Study Details

Brief summary:

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.

Conditions

Bipolar I Disorder

Mania

Study ID

NCT07288320

Start date

Dec 24, 2025

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1117568

Participants will receive NBI-1117568.

placebo comparator: Placebo

Participants will receive placebo matching NBI-1117568.

Interventions

NBI-1117568

Oral administration

Placebo

Oral administration

Primary outcome measure

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21 [ Time Frame: Baseline, Day 21 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Neurocrine Clinical Site

Recruiting

Garden Grove, California, United States, 92845

Neurocrine Clinical Site

Recruiting

San Diego, California, United States, 92123

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30331

Neurocrine Clinical Site

Recruiting

Gaithersburg, Maryland, United States, 20877

Neurocrine Clinical Site

Recruiting

Marlton, New Jersey, United States, 08053

Neurocrine Clinical Site

Recruiting

Staten Island, New York, United States, 10314

Neurocrine Clinical Site

Recruiting

Austin, Texas, United States, 78754

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

Bipolar I Disorder
Mania
NBI-1117568

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-07-31.