ISRCTN77185302
Completed
未知
The effects of cognitive training and modafinil on cognition and functioning in healthy subjects: a double-blind, randomised placebo-controlled group trial
Kings College London (KCL) (UK)0 sites24 target enrollmentJanuary 8, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cognitive functioning
- Sponsor
- Kings College London (KCL) (UK)
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants will have no personal history of schizophrenia or other psychotic disorder
- •2\. Participants will have no family history to second degree relative, of schizophrenia or other psychotic disorder
- •3\. Age between 18 and 45 years
- •4\. Males and females
- •5\. Raw score of 6 or greater on the Wechsler Test of Adult Reading (WTAR)
- •6\. A negative result in a pregnancy test performed prior to the trial
- •7\. Use of effective contraceptive methods for the duration of the trial
- •8\. Subjects must read and write English at a level sufficient to understand and complete study\-related procedures
- •9\. 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.
- •10\. Written and witnessed informed consent
Exclusion Criteria
- •1\. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM\-IV) diagnosis of alcohol or drug dependence in the 3 months preceding the screening visit
- •2\. No current treatment with psychostimulants, modafinil, cyclosporine, phenytoin, oestrogens, anticoagulants or barbiturates
- •3\. Pregnant or breast\-feeding women
- •4\. History of a neurological disorder or a systemic illness with known neurological complications
- •5\. Head injury
- •6\. Uncontrolled hypertension, arrhythmia, left ventricular hypertrophy
- •7\. Any known drug allergies, including sensitivity to modafinil, and the development a drug\-associated rash in the past
- •8\. Unwillingness or inability to follow or comply with the procedures outlined in the protocol
- •9\. Participation in other ongoing medicinal trial or within the last four months
Outcomes
Primary Outcomes
Not specified
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