The effects of cognitive training and modafinil on cognition and functioning in healthy subjects
| ISRCTN | ISRCTN77185302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77185302 |
| Secondary identifying numbers | RAA09-002 |
- Submission date
- 15/10/2010
- Registration date
- 08/01/2013
- Last edited
- 17/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Shitij Kapur
Scientific
Scientific
Institute of Psychiatry
de Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0593 |
|---|---|
| shitij.kapur@kcl.ac.uk |
Study information
| Study design | Double-blind randomised placebo-controlled group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effects of cognitive training and modafinil on cognition and functioning in healthy subjects: a double-blind, randomised placebo-controlled group trial |
| Study acronym | CogMod |
| 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. |
| Ethics approval(s) | Moorfields and Whittington Research Ethics Committee, 30/04/2010, ref: 10/H0721/25 |
| Condition | Cognitive functioning |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 18/07/2010 |
| Overall study end date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 18/07/2010 |
| Recruitment end date | 01/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
Kings College London (KCL) (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
Camberwell
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 0251 |
|---|---|
| jennifer.liebscher@kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk/departments/?locator=26 |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research council
Medical Research Council - Strategic Appointments Scheme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No |
Editorial Notes
17/05/2016: Publication reference added.
