The effects of cognitive training and modafinil on cognition and functioning in healthy subjects

Not Applicable

Completed

• Conditions: Cognitive functioning; Signs and Symptoms; Other symptoms and signs involving cognitive functions and awareness

• Registration Number: ISRCTN77185302
• Lead Sponsor: Kings College London (KCL) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of the combination of modafinil and cognitive training on learning capacity of the research participants, i.e. the percentage of correct responses and mean response time on the cognitive training tasks as a function of cognitive training, and the effect of the cobmination of modafinil and training on the cognitive outcome measures (MATRICS Consensus Cognitive Battery [MCCB] and CogState). <br><br>Outcomes will be measured every day during the combined intervention period (Day 2 to Day 11) and also once during the 2nd week of the follow-up period.

Secondary Outcome Measures

Name	Time	Method
1. Change in the composite scores of the neuropsychological batteries (CogState and MCCB) scores following a single dose of modafinil - this measures the difference in scores between the second and third assessments (pre-training) <br>2. Reliabillity of CogState and MACCB batteries in the face of repeating testing - performance will be examined across the 5 assessments; 3 pre-training assessments, and 2 post-training