Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia.
- Conditions
- SchizophreniaMedDRA version: 18.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-004878-42-BG
- Lead Sponsor
- Minerva Neurosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 234
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-5), 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 <4 on:
-P4 Excitement, hyperactivity
- P7 Hostility
- P6 Suspiciousness
- G8 Uncooperativeness
- G14 Poor impulse control
8. Patients can be on any psychotropic as long as the psychotropic can be discontinued at the beginning of the washout phase without endangering the patient’s safety.
9. No change in any psychotropic medication during the last month (changes are allowed if done for administrative reasons or with the permission of the Sponsor’s Responsible Medical Officer).
10. No history of violence against self, others, or property.
11. Patient in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is indicated.
12. Female patient, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method.
13. Patient must be extensive metabolizers for P450 CYP2D6, as determined by genotyping test before the first drug dose is administered.
14. Patient must be able to understand the nature of the study.
15. The patient is considered by the investigator to be reliable and likely to cooperate with the assessment procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method