Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Judy Rubinsztein


Contact details

Wedgwood House
West Suffolk Hospital
Hardwick Lane
Bury St Edmunds
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

2005/165: version 2

Study information

Scientific title

Enhancing cognition in bipolar disorder


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


Secondary study design

Randomised cross over trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Bipolar disorder


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



Not Applicable

Drug names


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 trial start date


Overall trial end date


Reason abandoned (if study stopped)

Participant recruitment issue


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


Age group




Target number of participants


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 John’s 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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

West Suffolk Hospital
Bury St Edmunds
United Kingdom

Sponsor information


Suffolk Mental Health Partnership NHS Trust (UK)

Sponsor details

c/o Mr Robert Bolas
Research and Development Office
Post Bag Code NO05
Ipswich Hospital
IP4 5 PD
United Kingdom

Sponsor type




Funder type

Hospital/treatment centre

Funder name

Suffolk Mental Health Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes