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RecruitingPhase 3

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

Neurocrine Biosciences · NCT06963034

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
284
US sites recruiting
21
Study start
May 8, 2025
Record last updated
March 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: NBI-1117568; Placebo

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Neurocrine Medical Information Call Center · 877-641-3461 · medinfo@neurocrine.com
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NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults… (NCT06963034) | Bored Studies