NCT00304616已完成4 期
A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
研究概览
简要总结
To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration
详细描述
This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs.
Aripiprazole (10~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Men and women, ages 18 to
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
- •Patients who have not been hospitalized during last three months
- •Patients who have kept clinically stable dosage during last one month
- •Patients with a diagnosis of schizophrenia and schizoaffective disorder as defined by DSM-IV criteria
- •Patients whose symptoms are not optimally controlled or whose antipsychotic medication is not well-tolerated, which in the clinical judgment of the treating psychiatrist require a change of treatment.
- •Patients who have received antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine.
排除标准
- •Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •Women who are pregnant or breastfeeding
- •Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide
- •Patients with a diagnosis of bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- •Patients who have met DSM-IV criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
- •Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments
- •Treatment with a long-acting antipsychotic (i.e., haloperidol decanoate or fluphenazine decanoate) in which the last dose was within 3 weeks of randomization.
- •Patients with a history of neuroleptic malignant syndrome
- •Patients with epilepsy, a history of seizures (except for a single childhood febrile seizure), or a history of an abnormal EEG, severe head trauma, or stroke or who have a history or evidence of other medical conditions (e.g., congestive heart failure) that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
- •Patients who would be likely to require prohibited concomitant therapy during the trial
- •Patients who have previously enrolled in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month
- •Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
结局指标
主要结局
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
次要结局
- Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
- IAQ (at week 8)
- POM (at week 1, 2, 4, 8)
- GAF (at week 8 & end of study)
- CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
- AEs, Vital Signs, Weight gain, Prolactin increase, extrapyramidal syndrome, sleep disturbance, Laboratory tests (at week 1, 2, 4, 8 & every 4 weeks until week 26).
研究者
研究点 (2)
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