EUCTR2016-000285-28-DE进行中（未招募）1 期
A phase II randomised, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 425809 once daily over12 week treatment period in patients with Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 720
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
- •- Men or women who are 18-50 years (inclusive) of age at time of consent.
- •- Established schizophrenia with the following clinical features:
- •a) Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation;
- •b) Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation;
- •c) patients who have no more than a moderate severe rating on the PANSS positive items P1, P3-P7 and no more than a moderate rating on the PANSS positive item P2.
- •- Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1 must meet the criteria below:
- •a) patients may have up to 2 antipsychotics (typical and/or atypical);
- •b) patients must be maintained on current typical and/or atypical antipsychotics other than Clozapine and on current dose for at least 4 weeks prior to randomisation and/or maintained on current long acting injectable antipsychotics and current dose for at least 3 months prior to randomization;
- •c) patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepilectics and/or lithium for at least 3 months prior to randomisation and on current dose for at least 4 weeks prior to randomisation.
- •- Women of child-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly.
- •- Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures, in the investigator´s opinion.
- •- Patients must have an identified informant who will be consistent throughout the study.
- •-Further inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 504
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients who have a categorical diagnosis of another current major psychiatric disorder.
- •- Diseases of the central nervous system that may impact cognitive test performance.
- •- Movement disorder not currently controlled.
- •- Patients receiving another investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or recent participation in another trial with any cognitive enhancing therapy.
- •- Recent participation in formal cognitive remediation program.
- •- Recent electroconvulsive therapy.
- •- Patients who have been on BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia within the last 6 months prior to randomisation or who have previously been on bitopertin.
- •- Participation in a clinical trial with repeated MATRICS Consensus Cognitive Battery (MCCB) assessments within the last 6 months.
- •- Patients who required change in their ongoing stable benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation.
- •- Treatment with Clozapine within 6 months prior to randomisation.
- •- Treatment with medical devices (e.g. Transcranial Magnetic Stimulation (TMS), neurofeedback) for any psychiatric condition within the last 3 months prior to randomisation.
- •- Patients taking strong or moderate Cytochrome P450 (CYPA4) inhibitors or inducers within the last 30 days prior to randomisation.
- •- Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to randomisation.
- •- Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) prior to randomisation.
- •- Known history of Human Immunodeficiency Virus (HIV) infection, and/or a positive result for ongoing Hepatitis B or C infection on the Visit 1 central lab.
- •- Hemoglobin less than 120 g/L (12 g/dL) in men or 115 g/L (11.5 g/dL) in women.
- •-History of hemoglobinopathy such as thalassemia major or sickle-cell anemia.
- •- Women who are pregnant, nursing, or who plan to become pregnant while in the trial or men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of the study participation and for at least 28 days after treatment has ended.
- •- Significant history of drug abuse disorder (including alcohol) within the last 6 months prior to informed consent or a positive urine drug screen at screening.
- •- Further exclusion criteria apply.
研究者
相似试验
进行中（未招募）
1 期
Clinical trial of BI 425809 effect on cognition and functional capacity in schizophreniaPatients with schizophrenia on stable antispychotic treatmentMedDRA version: 20.0Level: LLTClassification code 10039634Term: Schizophrenia residualSystem Organ Class: 100000004873EUCTR2016-000285-28-ITBOEHRINGER-INGELHEIM ITALIA S.P.A.720
进行中（未招募）
1 期
Clinical trial of BI 425809 effect on cognition and functional capacity in schizophreniaPatients with schizophrenia on stable antispychotic treatmentMedDRA version: 19.0 Level: LLT Classification code 10039634 Term: Schizophrenia residual System Organ Class: 100000004873EUCTR2016-000285-28-ATBoehringer Ingelheim RCV GmbH & Co KG720
进行中（未招募）
1 期
A study to investigate the efficacy, safety and tolerability of four different doses of BI 409306 compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.Patients with schizophrenia on stable antispychotic treatmentMedDRA version: 18.1Level: LLTClassification code 10039634Term: Schizophrenia residualSystem Organ Class: 100000004873EUCTR2013-005015-28-DEBoehringer Ingelheim Pharma GmbH & Co. KG722
进行中（未招募）
1 期
Clinical trial of BI 425809 effect on cognition and functional capacity in schizophreniaPatients with schizophrenia on stable antispychotic treatmentMedDRA version: 19.0Level: LLTClassification code 10039634Term: Schizophrenia residualSystem Organ Class: 100000004873EUCTR2016-000285-28-ESBoehringer Ingelheim España, S.A.684
进行中（未招募）
1 期
KARE: Ketamine for reduction of Alcoholic RelapseEUCTR2015-000222-11-GBniversity College London96