Schizophrenia MedDRA version: 17.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: MIN-101
Product Code: MIN-101
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: MIN-101
CAS Number: 359625-80-2
Current Sponsor code: MIN-101
Concentration unit: mg mill
Sponsors
Minerva Neurosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient or patient's legal representative has provided informed consent. 2. Male or female patient, 18 to 60 years of age, inclusive. 3. Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview (MINI). 4. Patient is stable in terms of positive symptoms of schizophrenia over the last 3 months according to his or her treating psychiatrist 5. Patient is stable in terms of negative symptoms of schizophrenia over the last 3 months according to his or her treating psychiatrist 6. Patient with PANSS negative subscore of at least 20. 7. Patient with PANSS item score of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of mental retardation. 2. Patient’s condition is due to direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition. 3. Significant risk of suicide or attempted suicide, or of danger to self or others. 4. Patient has a history of substance abuse within 3 months of the Screening visit (excluding caffeine and cigarette smoking). 5. Positive urine drug screen except when related to prescribed benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction). 6. Patient who cannot be discontinued from psychotropics other than those allowed. 7. Patient who received clozapine within 6 months of the Screening visit. 8. Patient receiving treatment with depot antipsychotic medication can be enrolled in the study 4 weeks after the last injection. 9. Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder. 10. Patient with a history of epilepsy seizure disorder (patient with a history of childhood febrile seizure may be enrolled in this study). 11. Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 3 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study. 12. Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit. 13. Body Mass Index (BMI) > 35. 14. Current systemic infection (e.g., Hepatitis B virus [HBV], Hepatitis C virus [HCV], human immunodeficiency virus [HIV], tuberculosis [TB]). 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/ serum glutamic pyruvic transaminase (ALT/SGPT) and aspartate aminotransferase/ serum glutamic oxaloacetic transaminase (AST/SGOT) do not exceed 2 times upper limit of normal (ULN). 15. Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone). 16. Patient who requires medication inhibiting the CYP 2D6. 17. Patient with a clinically significant electrocardiogram (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. 18. Patient with a history of myocardial infarction based on medical history or ECG findings at Screening. 19. Familial or personal history of long QT syndrome or with additional risk factors for torsade de Pointes (e.g., hypokalemia, hypomagnesemia). 20. Woman of child-bearing potential, or man, who are unwilling or unable to use accepted methods of birth control. 21. Woman with a positive pregnancy test, is lactating, or is planning to become pregnant during the study. 22. Patient who participated in another clinical study within 3 months prior to Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score of the pentagonal model over 12 weeks of treatment.;Secondary Objective: - To evaluate the efficacy of MIN-101 compared to placebo in improving other symptoms of schizophrenia as measured by the change from Baseline in the PANSS total score, positive symptoms score, dysphoric mood, activation, and autistic preoccupation subscores of the pentagonal model over 12 weeks of double-blind treatment. -To evaluate the efficacy of MIN-101 compared to placebo in improving symptoms of schizophrenia as measured by the change from Baseline in the PANSS total score and subscores according to the 3 factors analysis over 12 weeks of double-blind treatment. - To evaluate the efficacy of MIN-101 compared to placebo in improving negative symptoms of schizophrenia as measured by the change from Baseline in the Brief Negative Symptoms Scale (BNSS) total score over 12 weeks of double-blind treatment. - To assess the effects of MIN-101 compared to placebo on the CGI-S and CGI-I over 12 weeks of double-blind treatment. For futher information please see protocol section 2;Primary end point(s): Change from baseline in PANSS negative subscale;Timepoint(s) of evaluation of this end point: Baseline and Weeks 2, 4, 8, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the PANSS total score and Positive, Dysphoric mood, Activation, and Autistic preoccupation subscores of the pentagonal model Change from Baseline in the PANSS total score and subscores according to the 3 factors analysis Change from baseline in the Brief Negative Symptoms Scale Change from baseline in Brief Assessment of Cognition in Schizophrenia Change from baseline in CGI-S and CGI-I Safety and tolerability (assessed through physical examination, adverse event reporting, electrocardiogram, vital signs assessment, Sheehan suicidality scale, Abnormal Involuntary movement Scale ) Persistence of efficacy, and the safety and tolerability of MIN-101 during the 24-week, open-label extension phase. ;Timepoint(s) of evaluation of this end point: For: Change from baseline in the PANSS total score and Positive, Dysphoric mood, Activation, and Autistic preoccupation subscores of the pentagonal model- Baseline and Weeks 2, 4, 8, 12 For: Change from Baseline in the PANSS total score and subscores according to the 3 factors analysis-and Change from baseline in the Brief Negative Symptoms Scale - Baseline and Weeks 2, 4, 8, 12 For: Change from baseline in Brief Assessment of Cognition in Schizophrenia- Baseline and Weeks 4 and 12 For: Change from baseline in CGI-S and CGI-I-Baseline and Weeks 4, 8, 12 For: Safety and tolerability (assessed through physical examination, adverse event reporting, electrocardiogram, vital signs assessment, Sheehan suicidality scale, Abnormal Involuntary movement Scale ) - over 12 weeks of treatment | — |
Countries
Bulgaria, Estonia, Latvia, Romania, Russian Federation, Ukraine
Contacts
Public ContactSYMPHONIA - helpdesk
KCR S.A.
Outcome results
None listed