EUCTR2012-002785-12-IT进行中（未招募）不适用
A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients withschizophrenia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 286
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
- •? The patient has schizophrenia, diagnosed according to DSM-IV TR™.
- •? The patient is a man or woman, aged =18 and =60 years.
- •? The patient has been prescribed oral antipsychotic treatment for the full 3 months prior to the Screening Visit.
- •? The patient has CGI-S score =3 (mildly ill) and =5 (markedly ill) at the Screening and Baseline Visits .
- •? The patient is in need of a change in the current antipsychotic treatment and in the judgement of the
- •investigator the patient would benefit from an extended treatment with a once-monthly formulation, including
- •but not limited to any of the following reasons:
- •- lack of adequate response to his or her current antipsychotic medication,
- •- poor tolerability to his or her current antipsychotic medication,
- •- lack of adherence to his or her current antipsychotic medication.
- •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 286
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-IV™ criteria) other than
- •schizophrenia established as the primary diagnosis.
- •? The patient has a substance use disorder (except nicotine) which according to the investigator’s judgment may
- •compromise the patient’s ability to comply with the study procedures, or preclude the benefits of the study
- •medication.
- •? The patient in the investigator’s judgment has shown significant intolerance and/or lack of efficacy to oral
- •aripiprazole, paliperidone or risperidone, in a manner that would preclude benefiting from the study
- •medication if randomised to the same IMP during the study.
- •? The patient has been treated with a long-acting injectable atypical antipsychotic drugs such as olanzapine,
- •paliperidone, or aripiprazole <6 months prior to the Screening Visit.
- •? The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the
- •Screening and Baseline Visits.
- •? The patient is hospitalised at the time of the Screening Visit for a period longer than 3 months.
- •? The patient is considered resistant to antipsychotic treatment according to the investigator’s judgement, or has
- •a history of failure to respond to clozapine treatment, or a history of responding only to clozapine treatment.
- •? The patient is at significant risk of harming himself/herself or others according to the investigator’s judgement
- •or as indicated by an answer of yes” to questions 4 or 5 on the C-SSRS at the Screening or Baseline Visit.
研究者
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