Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2005/165: version 2
Study information
Scientific title
Enhancing cognition in bipolar disorder
Acronym
Study hypothesis
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
Suffolk Local Research Ethics Committee, 19/08/2005, LREC number: 05/Q0102/71
Study design
Double-blind placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Modafinil
Primary outcome measures
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 trial start date
01/08/2005
Overall trial end date
01/08/2008
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/08/2005
Recruitment end date
01/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Suffolk Hospital
Bury St Edmunds
IP4 5PD
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Suffolk Mental Health Partnership NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary