Phase
Condition
Tourette's Syndrome
Psychosis
Mood Disorders
Treatment
Placebo
NBI-1117568
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participant has a primary diagnosis of schizophrenia
Participant is experiencing an acute exacerbation or relapse of symptoms andcurrently warrants hospitalization.
Participants taking prohibited medications, including antipsychotics, mustdiscontinue before study participation
Participant is willing and able to remain in an inpatient setting for the studyduration, follow instructions, and comply with the protocol requirements
Exclusion
Key Exclusion Criteria:
Participant has known hypersensitivity to any component of the formulation ofNBI-1117568.
Participant has an unstable or poorly controlled medical condition or chronicdisease
Participant is considered by the investigator to be at imminent risk of suicide orinjury to self or others
Participant has a diagnosis of moderate or severe substance use disorder (with theexception 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 clinicalresearch studies and/or in the investigator's opinion, the participant is notcapable of adhering to the protocol requirements.
Note: Other protocol-specified inclusion/exclusion criteria may apply.