Enhancing cognition in bipolar disorder

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on tests of attention, memory and executive function, assessed 2 hours after taking the drug/placebo by the following: <br><br>Symptom Rating Scales: <br>1. Hamilton depression scale<br>2. Young mania scale<br>3. Beck depression inventory<br>4. Apathy scale<br>5. Epworth sleepiness scale<br>6. Bond and Lader scale<br> <br>Neuropsychological Tests: (CAmbridge Neuropsychological Test Automated Battery). [CANTAB])<br>7. Digit Span<br>8. Controlled oral word association test<br>9. Motor Screening<br>10. Pattern recognition memory test<br>11. Spatial recognition memory test<br>12. Big/ little circle<br>13. Rapid visual information processing task<br>14. Rey auditory verbal learning test<br>15. Attentional set shifting task<br>16. One Touch Tower of London task<br> <br>All tests will be carried out on both testing sessions (one week apart).

Secondary Outcome Measures