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21 March 2013
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| [ Print-friendly version ] |
| The effects of cognitive training and modafinil on cognition and functioning in healthy subjects |
| ISRCTN | ISRCTN77185302 |
| DOI | 10.1186/ISRCTN77185302 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The effects of cognitive training and modafinil on cognition and functioning in healthy subjects |
| Scientific title | The effects of cognitive training and modafinil on cognition and functioning in healthy subjects: a double-blind, randomised placebo controlled group trial |
| Acronym | CogMod |
| Serial number at source | RAA09-002 |
| Study hypothesis |
Procedure:
It is of considerable academic and clinical interest to investigate whether and to what extent cognitive functioning can be ameliorated as this may have broad advantages for clinical populations. The strategies to improve cognition include pharmacological (based on modulation of brain chemistry), and non-pharmacological approaches (based on training interventions to improve cognitive abilities) and research has shown that both approaches can modestly improve cognition. We propose to combine the two approaches of both pharmacology and cognitive intervention to study the extent of their combined effect in improving cognition. Participants will be randomly allocatead to receive either modafinil (the pharmacological cognition-enhancing agent) or an inactive compound and will undergo cognitive training sessions, during which they will complete attention, memory and learning tasks. Level of cognitive performance will be measured before and after the intervention so that change can be measured. It is hypothesised that combination of modafinil with cognitive training will enhance the learning capacity of the research participants compared to placebo and cognitive training. We expect that cognitive enhancement will generalize into increased performance on standard (not part of cognitive training) neuropsychological tests. We also expect that the improved performance of participants receiving the combination of modafinil with cognitive training on neuropsychological assessments will be retained after the discontinuation of the training and medication. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Moorfields and Whittington Research Ethics Committee approved on the 30th April 2010 (ref: 10/H0721/25) |
| Study design | Double-blind randomised placebo controlled group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cognitive functioning |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 18/07/2010 |
| Anticipated end date | 01/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 24 |
| Interventions |
1. Intervention: cognitive training and modafinil
2. Control: cognitive training and placebo The study is a randomised controlled trial. Participants will be randomised to receive a cognitive enhancer (modafinil) or placebo. Study participants will receive 200 mg of modafinil once/day for 12 days. The first day of modafinil/placebo treatment, we will assess the effects of a single dose of modafinil on the participants' neuropsychological performance. From day 2 to day 11, all participants will undergo cognitive training exercises after having received the daily dose of modafinil/placebo. On day 12 we will assess the effects of modafinil/placebo+ cognitive training combination on neuropsychological performance. |
| Primary outcome measure(s) |
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).
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 measure(s) |
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)
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 |
| Sources of funding | Medical Research Council (MRC) (UK) - Strategic Appointments Scheme |
| Trial website | |
| Publications | |
| Contact name | Prof Shitij Kapur |
| Address |
Institute of Psychiatry
de Crespigny Park Camberwell |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 0593 |
| shitij.kapur@kcl.ac.uk | |
| Sponsor | Kings College London (KCL) (UK) |
| Address |
Institute of Psychiatry
De Crespigny Park Camberwell |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 0251 |
| jennifer.liebscher@kcl.ac.uk | |
| Sponsor website: | http://www.iop.kcl.ac.uk/departments/?locator=26 |
| Date applied | 15/10/2010 |
| Last edited | 14/01/2013 |
| Date ISRCTN assigned | 08/01/2013 |
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