Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 62
- 主要终点
- The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
研究概览
简要总结
The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.
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
- Double
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
- •Schizophrenic patient meeting the DSM-IV diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
- •Outpatient (or patient admitted to hospital for social or logistic reasons).
- •Patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit
- •Patient presenting a PANSS score equal or greater than 49 at Visit
- •Patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.
排除标准
- •Patient presenting a schizophreniform or a schizo-affective disorder according to the DSM-IV diagnostic criteria, or any other disorder from Axis I of the DSM-IV, or a disorder from Axis II (limit personality), substance dependence or substance abuse.
- •Administration of an atypical antipsychotic drug during the 8 weeks preceding V
- •History of resistance to antipsychotic drugs
- •Hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
- •Presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.
结局指标
主要结局
The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
Psychiatric hospitalization.
A 25% increase in the total score on the PANSS scale (Kay SR et al. 1987) in relation to the score obtained at the baseline visit (Visit 2).
A major deterioration in clinical condition, defined by a score of 6 ("much worse") or 7 ("very much worse") on the CGI-I scale (Clinical Global Impression-Improvement)
Suicide attempt requiring medical treatment and/or jeopardizing vital prognosis (self-mutilation, ingestion of a toxic substance, defenestration, self-mutilation with suicidal intent).
次要结局
- Intention Reading Task in a real-life situation
- The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
- Positive and negative symptom scale : PANSS
- Clinical global impression scale: CGI [Clinical global impression-severity of illness (CGI-S); Clinical global impression-improvement of illness (CGI-I); Clinical Global Impression scale - Psychic distress]
- Schizophrenic Communication Disorder Rating Scale: SCD
- Social Interactions measurement tools
- Patient Outcome based on Preference Tool: POP
- Patient's quality of life: S-QOL