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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07288320

Enrollment

150

Registered

2025-12-17

Start date

2025-12-24

Completion date

2028-02-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder, Mania

Keywords

Bipolar I Disorder, Mania, NBI-1117568

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.

Interventions

DRUGPlacebo

Oral administration

DRUGNBI-1117568

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21	Baseline, Day 21

Secondary

Measure	Time frame
Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21	Baseline, Day 21

Countries

United States

Contacts

CONTACTNeurocrine Medical Information Call Center

medinfo@neurocrine.com1-877-641-3461

STUDY_DIRECTORClinical Development Lead

Neurocrine Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026