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NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
Key Inclusion Criteria:

* Participant has a primary diagnosis of schizophrenia
* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements

Key Exclusion Criteria:

* Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
* Participant has an unstable or poorly controlled medical condition or chronic disease
* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
* Participant has a positive alcohol test or drug screen for disallowed substances
* Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

About the study

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

What is being tested

Sponsor: Neurocrine Biosciences · Participants: 284 · Started: May 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06963034

Locations in the U.S.

ArkansasNeurocrine Clinical Site, Bryant
Neurocrine Clinical Site, Little Rock
CaliforniaNeurocrine Clinical Site, Anaheim
Neurocrine Clinical Site, Pico Rivera
Neurocrine Clinical Site, San Diego
Neurocrine Clinical Site, Sherman Oaks
Neurocrine Clinical Site, Torrance
FloridaNeurocrine Clinical Site, Hollywood
Neurocrine Clinical Site, Miami Lakes
GeorgiaNeurocrine Clinical Site, Atlanta
Neurocrine Clinical Site, Decatur
Neurocrine Clinical Site, Snellville
IllinoisNeurocrine Clinical Site, Chicago
MarylandNeurocrine Clinical Site, Gaithersburg
MassachusettsNeurocrine Clinical Site, Watertown
New JerseyNeurocrine Clinical Site, Marlton
New YorkNeurocrine Clinical Site, Staten Island
Neurocrine Clinical Site, The Bronx
TexasNeurocrine Clinical Site, Austin
Neurocrine Clinical Site, DeSoto
Neurocrine Clinical Site, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.