A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)
Novartis Pharmaceuticals
Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is aged 18 to 65 years, inclusive, at screening 2. Participant is capable of providing informed consent 3. Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT) 4. Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requir…
Interventions
- DrugGXV813
GXV813 administered orally.
- DrugPlacebo
Placebo administered orally.
Locations (7)
- Pillar Clinical Research LLCBentonville, Arkansas
- CNRI Los Angeles LLCPico Rivera, California
- Segal Institute for Clinical ResearchMiami, Florida
- CenExel iResearchDecatur, Georgia
- Uptown Research Institute LLCChicago, Illinois
- Pillar Clinical Research LLCChicago, Illinois