PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- the ESRS (Extrapyramidal Symptom Rating Scale)
研究概览
简要总结
The present study will specify and delineate the separate components of cognitive deficits and examine the effects of adjunctive cholinergic augmentation on these cognitive deficits as well as psychopathology in schizophrenic patients treated with an antipsychotic compound with no aberrant binding affinity for the cholinergic receptor system. The hypothesis is that cholinergic augmentation using donepezil will improve cognitive deficits, sensory gating deficits, and psychopathology in schizophrenic patients treated with an atypical antipsychotic (ziprasidone).
详细描述
The purpose of the study was to examine the effects of cholinergic augmentation of atypical antipsychotic medication on:
- Cognitive deficits
- Sensorimotor gating
- Psychopathology
The primary objective was to examine:
• The effects of donepezil, compared to the effects of placebo, on cognitive function, sensorimotor gating and psychopathology in patients treated with an atypical antipsychotic (ziprasidone).
Secondary objectives are to examine:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients: Men and women between the ages 18 to 55 who meet the ICD-10 criteria for schizophrenia living in the catchment area of the psychiatric departments of Bispebjerg University Hospital, Psychiatric Center, Glostrup and Rigshospitalet. Patients can be either unmedicated, or need to be switched from other antipsychotic medications due to side-effects, or lack of effect on negative symptoms, positive symptoms, or cognitive function.
- •Controls: Healthy men and women matched according to gender, age, and socio-economic status (determined by the level of education and income of parents).
排除标准
- •Patients: Patients hospitalized against their will. Patients with a serious medical illness or with laboratory abnormalities, where pharmacotherapy poses a substantial clinical risk; pregnant or lactating patients; patients with organic psychosis, a history of severe head trauma or convulsive disorders, or patients with mental retardation. Patients with significant alcohol- or drug dependence are excluded.
- •Controls: Pregnant or lactating women; a history of severe head trauma; mental retardation; learning difficulties; a history of psychiatric illness or a familial predisposition to psychiatric illness (in first-degree relatives); significant alcohol- or drug dependence; episodic incidents of excessive alcohol consumption or drug abuse are not reasons for exclusion. Abuse is monitored by interviewing patients and by measuring the urine content for amphetamine, cannabinoles, opiates, and benzodiazepines. Concomitant use of benzodiazepines for agitation or insomnia (oxazepam up to 45 mg daily) is allowed when needed and when used conservatively during the trial. Use of anticholinergic compounds is not allowed.
研究组 & 干预措施
1
干预措施: donepezil (5-10 mg/day) (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
the ESRS (Extrapyramidal Symptom Rating Scale)
时间窗: baseline and after treatment
PANSS (Positive and Negative Symptom Scale)
时间窗: baseline and after treatment
Cognitive functions: A comprehensive test battery focuses on central cognitive deficits in schizophrenia: i.e. memory functions, attention, executive functions, reaction time, as well as pre-morbid and current intelligence.
时间窗: baseline and after treatment
the CGI (Clinical Global Impression scale)
时间窗: baseline and after treatment
次要结局
- MRI(baseline and after treatment)
- fMRI(baseline and after treatment)
研究者
Birte Glenthoj
Professor
University of Copenhagen