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NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

NCT07105098

RecruitingPhase 3

Sponsor: Neurocrine Biosciences

Conditions: Schizophrenia

Interventions: NBI-1117568, Placebo

Countries: United States, Bulgaria, Hungary, Romania, Serbia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
* Participant has 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.
Locations (15)
  • Culver City, California, United States
  • Garden Grove, California, United States
  • Riverside, California, United States
  • Atlanta, Georgia, United States
  • North Canton, Ohio, United States
  • Sliven, Bulgaria
  • Veliko Tarnovo, Bulgaria
  • Vratsa, Bulgaria
  • Győr, Hungary
  • Brasov, Romania
  • Brasov, Romania
  • Bucharest, Romania
  • Belgrade, Serbia
  • Gornja Toponica, Serbia
  • Kragujevac, Serbia