A phase III randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-2)

ozaki Kenma0 个研究点目标入组 586 人开始时间: 2021年8月13日最近更新: 2023年10月17日

适应症

试验速览

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•Male or female patients who are 18-50 years (inclusive) of age at time of consent.
•Diagnosis of schizophrenia utilizing Diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) with the following clinical features:
•- Outpatient, clinically stable and in the residual (nonacute) phase of their illness.
•- No hospitalization1 or increase in level of psychiatric care2 due to worsening of schizophrenia within 12
•weeks prior to randomization.
•- PANSS score: items P1, P3-P6 are 5 or lower and item P2 and P7 are 4 or lower at Visit 1, and confirmed at Visit 2.
•Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties staying focused, difficulties remembering instructions, what to say or how to get to places, per investigator judgement.

•Patient with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar,
•schizoaffective, major depressive disorder etc. M.I.N.I. for psychotic disorders should be used for guidance.
•Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia.
•Any suicidal behavior in the past 1-year prior to screening and during the screening period.

发起方

ozaki Kenma