Enhancing cognition in bipolar disorder
| ISRCTN | ISRCTN93360820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93360820 |
| Secondary identifying numbers | 2005/165: version 2 |
- Submission date
- 16/05/2007
- Registration date
- 16/07/2007
- Last edited
- 24/02/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Judy Rubinsztein
Scientific
Scientific
Wedgwood House
West Suffolk Hospital
Hardwick Lane
Bury St Edmunds
IP4 5PD
United Kingdom
Study information
| Study design | Double-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Enhancing cognition in bipolar disorder |
| Study objectives | Patients with bipolar affective disorder, currently in remission, will show enhanced cognition on tests of attention, executive function and memory after taking a single dose of modafinil compared with performance on the placebo. |
| Ethics approval(s) | Suffolk Local Research Ethics Committee, 19/08/2005, LREC number: 05/Q0102/71 |
| Health condition(s) or problem(s) studied | Bipolar disorder |
| Intervention | Participants will be randomized to oral administration of one dose of modafinil (200 mg) or one dose of placebo (double blind). After a minimum of one-week washout period a cross-over intervention will be carried out. The interventions started in July 2006. Updated 24/02/2015: the trial was stopped due to poor recruitment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure | Performance on tests of attention, memory and executive function, assessed 2 hours after taking the drug/placebo by the following: Symptom Rating Scales: 1. Hamilton depression scale 2. Young mania scale 3. Beck depression inventory 4. Apathy scale 5. Epworth sleepiness scale 6. Bond and Lader scale Neuropsychological Tests: (CAmbridge Neuropsychological Test Automated Battery). [CANTAB]) 7. Digit Span 8. Controlled oral word association test 9. Motor Screening 10. Pattern recognition memory test 11. Spatial recognition memory test 12. Big/ little circle 13. Rapid visual information processing task 14. Rey auditory verbal learning test 15. Attentional set shifting task 16. One Touch Tower of London task All tests will be carried out on both testing sessions (one week apart). |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/08/2005 |
| Completion date | 01/08/2008 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. All patients must be able to give informed written consent to participate in the study 2. Aged 18 to 65 3. English should be spoken fluently 4. Participants should be literate and have normal or corrected to normal eyesight 5. All patients must have met Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) criteria for Bipolar I disorder in the past i.e. they must have had an episode of mania or a mixed affective state 6. The Hamilton Depression Rating Scale and Young Mania Scale scores must both be less than eight |
| Key exclusion criteria | 1. Patients who currently fulfill criteria for mania, a mixed affective state, hypomania or major depression 2. Patients who score less than or equal to 24 on the Mini-Mental State Examination (MMSE). All patients with a diagnosis of dementia will be excluded after review of case-records and/or discussion with their clinician 3. Current diagnosis of alcohol or drug dependence based on DSM IV criteria 4. History of learning disability (or Wechsler test of Adult Reading score <90) or dyslexia 5. Any known neurological illness (including narcolepsy) 6. Unstable medical illness that may affect cognition (untreated thyroid disease, type I diabetes mellitus or current treatment with steroids) 7. Have received electroconvulsive therapy in the past three months 8. Patients taking herbal remedies such as St Johns Wort or Gingko Biloba 9. Moderate or severe hypertension. All patients should have blood pressure measurements within normal limits (i.e. systolic blood pressure less than or equal to 160 and diastolic blood pressure less than or equal to 90) prior to drug administration 10. Known history of angina or cardiac arrhythmias 11. Pregnant or breastfeeding 12. Patients taking phenytoin (due to possible increase in plasma concentration) 13. Known hypersensitivity to modafinil or its excipients, or to the placebo 14. Participated in another clinical drug trial within the last three months 15. Female patients on an Oral Contraceptive (OC) will need to be counselled about the possibility that modafinil may reduce the effectiveness of the OC. They will only be excluded if they are not willing to take the family planning advice recommendations in the British National Formulary (BNF) (for the short term course of an enzyme inducing drug) 16. Patients who have had any changes to their psychotropic drugs over the past six weeks |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Suffolk Hospital
Bury St Edmunds
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Sponsor information
Suffolk Mental Health Partnership NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Robert Bolas
Research and Development Office
Post Bag Code NO05
Ipswich Hospital
Ipswich
IP4 5 PD
United Kingdom
"ROR" |
https://ror.org/03400ft78 |
|---|
Funders
Funder type
Hospital/treatment centre
Suffolk Mental Health Partnership NHS Trust (UK)
No information available
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 |
