A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
Minerva Neurosciences
Summary
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 In…
Interventions
- DrugRoluperidone
Roluperidone 64 mg
- Drugrisperidone
risperidone 4 mg
- Drugaripiprazole
aripiprazole 10 mg
- Drugolanzapine
olanzapine 10 mg
- DrugPlacebo
Placebo
Locations (2)
- CBH Health, LLC dba CenExelGaithersburg, Maryland
- Hassman Research Institute, LLC dba CenExelMarlton, New Jersey