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RecruitingPhase 3

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

A Global, 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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NBI-1117568 works better than a placebo (a treatment with no active drug) to improve behavior and mental symptoms of schizophrenia. It is for adults with schizophrenia whose symptoms have worsened or returned and who need hospital care. Other study rules may also apply.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your main diagnosis is schizophrenia.
  • Your symptoms have recently worsened or returned, and you need hospital care.
  • You must stop medicines that the study does not allow, including antipsychotics (medicines used to treat schizophrenia), before joining.
  • You are willing and able to stay in the hospital for the whole study, follow instructions, and meet study rules.

Who can't join

  • You have a known allergy to any ingredient in NBI-1117568.
  • You have a medical condition or long-term illness that is unstable or poorly controlled.
  • The study doctor believes you are at immediate risk of suicide or harming yourself or others.
  • You were diagnosed with a moderate or severe substance use disorder (problems related to alcohol or drug use) in the 6 months before screening. Nicotine or caffeine dependence does not count.
  • You test positive for alcohol or drugs that the study does not allow.
  • You have a history of not following, or being suspected of not following, research study rules, or the study doctor believes you cannot follow this study's rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (7)

AR

CA

FL

GA

OH