Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)
研究概览
简要总结
This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens
详细描述
This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years
- •Auditory and visual acuity adequate to complete cognitive tests
- •Stable dose of antipsychotics for at least 2 weeks prior to entry
- •Good physical health determined by complete physical examination, laboratory tests, and EKG
- •Capacity and willingness to give written informed consent.
排除标准
- •Inability to read or speak English
- •Documented disease of the central nervous system
- •History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
- •Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;
- •HIV positive
- •Patients on antidepressants, including monoamine oxidase inhibitors
- •Uncontrolled hypertension
- •Pregnancy
- •Patients with a current diagnosis of substance dependence
- •Significant history of violence
- •History of an eating disorder
- •Ready for discharge within the following 8 weeks.
研究组 & 干预措施
One arm
Study withdrawn due to lack of funds.
干预措施: modafinil (Drug)
结局指标
主要结局
Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)
时间窗: 8 weeks
Study withdrawn due to lack of funds.
次要结局
- Sedation and weight changes(8 weeks)
研究者
Jean-Pierre Lindenmayer
Study Principal Investigator
Manhattan Psychiatric Center