Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

Inclusion Criteria

• Patient and patient's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the patient is judged by the investigator as being capable of understanding the study requirements.
• Male or female patient, 18 to 55 years of age, inclusive, and body mass index (BMI) 20 on the PANSS negative subscore (the original PANSS scale [ Sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND 4 on: 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 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).
• Patient's condition is due to direct psychological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition.
• Has a current or recent history of serious suicidal behavior within the past 1 year.
• Patient has a history of substance use disorder within 3 months of the Screening visit (excluding caffeine and cigarette smoking).
• Positive urine drug screen for drugs of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription benzodiazepines).
• Patient who cannot be discontinued from psychotropics other than those allowed.
• Patient who received clozapine within 6 months of the Screening visit.
• Patient receiving treatment with long-acting or depot antipsychotic medication unless his/her next scheduled dose will occur during the protocol Screening period and can be omitted to allow for sufficient washout before receiving the study drug.
• Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
• Patient with a history of seizures (patient with a history of a single childhood febrile seizure may be enrolled in this study).
• Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 6 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study.
• Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation.
• Current systemic infection (e.g., Hepatitis B, Hepatitis C, human immunodeficiency virus [HIV], tuberculosis). Patients with positive Hepatitis B core antibody test and negative Hepatitis B surface Antigen (HBsAg) may be included in the study if aminotransferase levels (alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) [ALT/SGPT] and aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) [AST/SGOT] do not exceed 2 times upper limit of normal (ULN).
• Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).
• Patient who requires medication inhibiting CYP 2D6 or CYP 3A4.
• Patient with a clinically significant ECG abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia's formula (QTcF) > 430 msec for males and > 450 msec for females.
• Patient with a history of myocardial infarction based on medical history or ECG findings at Screening.
• Familial or personal history of long QT syndrome or with additional risk factors for Torsade de Pointes.
• Subjects whose safety laboratory results show hypokalemia, hypomagnesemia, hypocalcemia.
• Patients with unexplained syncope.
• Woman of child-bearin