Nautralsitic, Open-label, Single Arm Study Evaluating Effects of Aripiprazole LAI on Phychosocial&Congitive Functioning, Patient Reported Acceptability of Treatment Regarding QoL, Subjective Well-being Under Neuroleptic Medication in Sch
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 15
- 主要终点
- To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
研究概览
简要总结
Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients
详细描述
Primary Objective
- To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning, quality of life and patient reported acceptability of treatment. Secondary Objective(s)
- To evaluate the cognitive functioning of the patients
- To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),
- To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,
- To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18-45 of years age fulfilling DSM-IV-TR diagnostic criteria of schizophrenia,
- •Disease history of ≤ 3 years (≤ 3 years after the emergence of first psychotic symptoms),
- •A history of symptom exacerbation or relapse when not receiving antipsychotics therefore requiring maintenance antipsychotic treatment,
- •Informed written consent,
- •Not on any antipsychotic treatment at least for 3 months or requiring a switch in treatment for any reason (lack of efficacy/ inadequate response to current antipsychotic(s), intolerance, nonadherence), and with the potential to benefit from extended treatment with an LAI formulation, in the investigator's opinion.
- •Lack of efficacy is defined as subjects with a baseline total PANSS score ≥70 or ≥2 items scoring ≥4 in the Positive or Negative Symptom Subscale
- •Lack of tolerability is defined as the presence of clinically relevant side effects with the previous antipsychotic medication.
- •Being literate in order to be able to answer the self report scales.
排除标准
- •DSM-IV-TR diagnosis other than schizophrenia or experiencing acute depressive symptoms in the past 30 days requiring ADT depending on the clinical decision of the investigator.
- •Antipsychotic resistant or refractory schizophrenia
- •A history of failure to clozapine treatment or response to clozapine treatment only.
- •Significant risk of violent behavior or risk of self-harm
- •Currently meets DSM-IV-TR criteria for alcohol and substance dependence
- •Any clinically significant medical or neurological disorder
- •Any medically significant abnormal laboratory test or ECG result at screening
- •Pregnant, lactating.
研究组 & 干预措施
ARIPIPRAZOLE
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
干预措施: Aripiprazole 400mg LAI (Drug)
结局指标
主要结局
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
时间窗: 24 weeks
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia quality of life assesed with Heinrich's quality of life scale
时间窗: 24 weeks
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia patient reported acceptability of treatment assesed with Subjective Well Being Under Neuroleptic Treatment Scale
时间窗: 24 weeks
次要结局
- To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)(24 weeks)
- To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items(24 weeks)
- To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),(24 weeks)
- To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,(24 weeks)