NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurocrine Biosciences
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NBI-1117568
- Placebo
Treatment groups
284 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov