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

Detailed criteria

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…

Locations (16)

Pillar Clinical Research LLC
Bentonville, Arkansas
501-307-1919
CNRI Los Angeles LLC
Pico Rivera, California
Segal Institute for Clinical Research
Miami, Florida
CenExel iResearch
Decatur, Georgia
Uptown Research Institute LLC
Chicago, Illinois
Pillar Clinical Research LLC
Chicago, Illinois

Summary

Eligibility

Interventions

Locations (16)