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NCT Number: NCT07288320

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

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.

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Key information

Conditions

Bipolar I Disorder Mania Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurocrine Clinical Site, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBI-1117568

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21

    Time frame: Baseline, Day 21

Secondary outcomes

  1. Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21

    Time frame: Baseline, Day 21

Study contacts

Contact information is provided by the study sponsor or research team.

Neurocrine Medical Information Call Center

CONTACT

[email protected]

1-877-641-3461

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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