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 over 12 week treatment period in patients with Schizophrenia

Boehringer Ingelheim España, S.A.0 个研究点目标入组 684 人2016年6月7日

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注册库

who.int

开始日期

2016年6月7日

结束日期

2020年1月29日

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•\- 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

•\- 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 benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation
•\- Treatment with Clozapine within 6 months prior to randomisation