EUCTR2009-013020-23-GB进行中（未招募）1 期
A Pilot study of cognitive enhancer and cognitive training combination – Testing a therapeutic paradigm for cognitive impairment in schizophrenia - ModCTCoS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by Mini International Neuropsychiatric Interview (MINI)
- •Age between 18 and 60 years
- •Gender: Males and Females
- •Normal baseline electrocardiogram (ECG)
- •Duration of illness equal to or greater than one year
- •Patients should be clinically stable in a non-acute phase for at least 8 weeks prior to the screening visit
- •Subjects will meet the following symptom criteria
- •Positive and Negative Syndrome Scale (PANSS) Conceptual Disorganization item score = 4
- •PANSS Hallucinatory Behaviour or Unusual Thought Content item scores = 4
- •PANSS Negative Subscale scores on all items = 4
- •Subjects will meet the following cognitive performance criteria
- •Raw score of 6 or greater on the Wechsler Test of Adult Reading (WTAR)
- •Treatment with stable doses of atypical antipsychotics or stable doses of typical antipsychotics in the absence of concomitant anticholinergics for at least 4 weeks prior to the screening visit
- •Negative result in the urine pregnancy test performed during the screening visit in women of childbearing potential (not surgically sterile or 2 years postmenopausal)
- •Women of child-bearing potential, who are sexually active, will be considered as potential participants if they are using acceptable methods of contraception, which include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected). Women on combined and progestogen-only contraceptives and on contraceptive patches and vaginal rings will be required to use additional contraceptive precautions for the duration of the trial and 4 weeks after stopping taking modafinil for the study purposes because modafinil may reduce the effectiveness of both combined and progestogen-only contraceptives
- •Subjects must read and write in English at a level sufficient to understand and complete study-related procedures
- •Written and witnessed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit
- •Treatment with clozapine
- •Treatment with modafinil
- •Current treatment (within 4 weeks) with psychotropic agents known to affect cognition: amphetamines, barbiturates, lithium, MAOIs, methylphenidate, benzodiazepines, anticholinergics
- •Current treatment (within 4 weeks) with cyclosporine (modafinil reduces plasma concentration of cyclosporine), phenytoin (modafinil possibly increases plasma concentration of phenytoin), anticoagulants (modafinil increases the levels of anticoagulants), tricyclic antidepressants (modafinil may increase their levels)
- •Evidence of tardive dyskinesia, tardive dystonia or other severe
- •chronic movement disorders on physical examination
- •History of neuroleptic malignant syndrome
- •Pregnant or breast-feeding women
- •Clinically significant abnormalities on physical examination
- •History of a serious neurological disorder or a systemic illness with known neurological complications
- •Hypertension, arrhythmia, left ventricular hypertrophy, cor pulmonale, or clinically significant signs of CNS stimulant-induced mitral valve prolapse (including ischemic ECG changes, chest pain and arrhythmias), which pose a risk to the patient if they were to participate in the study
- •Any known drug allergies, including sensitivity to modafinil, and the development of drug-associated rash in the past
- •Unwillingness or inability to follow or comply with the procedures outlined in the protocol
- •Prior participation in a clinical trial of any psychotropic medication in the last 2 months preceding the screening visit
研究者
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