Tests NBI-1117568 against placebo for schizophrenia in hospitalized adults
Tests an investigational drug against placebo in adults with schizophrenia needing hospital care.
Plain-language title generated from the registry record
Registry title: NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Key facts
- Where
- Brasov, Bucharest, Jassi, and Sanpetru, RomaniaSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07105098, who can take part
Where in Romania
- Spitalul Clinic De Psihiatrie Si Neurologie BrasovBrasov, RomaniaTaking people
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
- Institutul De Psihiatrie Socola IasiJassi, RomaniaTaking people
- Spitalul Clinic De Psihiatrie Si Neurologie BrasovSanpetru, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT07105098EU 2025-521215-39-00
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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 known hypersensitivity to any component of the formulation of NBI-1117568; Participant has an unstable or poorly controlled medical condition or chronic disease; 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; Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others.