EUCTR2014-004878-42-EE进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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. [Country-specific exception: For patients in Russia, a dose of = 100 mg/day for the treatment of insomnia is allowed.]
- •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.
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