The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
Participant is aged 18 to 65 years, inclusive, at screening
Participant is capable of providing informed consent
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)
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 requirements
Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline
Parallel
GXV813
DrugGXV813 administered orally.
Placebo
DrugPlacebo administered orally.
Change from baseline in Positive and Negative Symptom Scale (PANSS) total score
PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity.
Number of participants with AEs
Assessment of overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia. This includes monitoring the occurrence and severity of adverse events, results of clinical laboratory tests, changes in vital signs, ECG findings, physical examinations.
Participant clinically significant response
Proportion of participants achieving a clinically significant response, defined as a ≥30% improvement in PANSS total score or a 1-point improvement in Clinical Global Impression-Severity (CGI-S) score from baseline at week 6, comparing GXV813 to placebo.
Change from baseline in PANSS positive sub-score
Assessment of the effect of GXV813 versus placebo on positive symptoms of schizophrenia, measured by the change from baseline in the PANSS positive sub-score at week 6., which measures symptoms that reflect an excess or distortion of normal mental functions. Each item is rated from 1 (absent) to 7 (extreme).
Change from baseline in PANSS negative sub-score
Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the PANSS negative sub-score (this sub-score is calculated by summing the ratings of seven items, each scored from 1 (absent) to 7 (extreme)) at week 6.
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