Evaluate the efficacy, as well as safety and pharmacokinetics, of Roluperidone in improving the negative symptoms of schizophrenia in adult subjects in Phase A of study, followed by Phase B of study to evaluate the relapse rate of Roluperidone and antipsychotic medications.
Subject and subject's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the subject is judged by the investigator as being capable of understanding the study requirements.
Male or female, 18 to 55 years of age, inclusive, and body mass index (BMI) </= 35.0 kg/m2 at Screening.
Meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview (MINI).
Has a caregiver or family member or health care personnel who can provide information towards assessment and support the subject in terms of compliance with the protocol. The caregiver must have contact with the subject frequently and is not expected to change during the trial.
Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14), drugs or alcohol addiction.
PANSS item score of > 4 on any of the following items: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
A Calgary Depression Scale for Schizophrenia (CDSS) total score > 6.
A score of >/= 2 on any 2 items of items 1, 2, or 3, or a score of >/= 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).