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

NCT ID: NCT07288320

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar I Disorder Mania

Keywords

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Bipolar I Disorder Mania NBI-1117568

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NBI-1117568

Participants will receive NBI-1117568.

Group Type EXPERIMENTAL

NBI-1117568

Intervention Type DRUG

Oral administration

Placebo

Participants will receive placebo matching NBI-1117568.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration

Interventions

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NBI-1117568

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurocrine Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Lead

Role: STUDY_DIRECTOR

Neurocrine Biosciences

Central Contacts

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Neurocrine Medical Information Call Center

Role: CONTACT

Phone: 1-877-641-3461

Email: [email protected]

Other Identifiers

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NBI-1117568-BPD2036

Identifier Type: -

Identifier Source: org_study_id