Bipolar affective disorder, currently in remission
Conditions
Interventions
Trade Name: Provigil
Product Name: provigil
Pharmaceutical Form: Capsule*
INN or Proposed INN: modafinil
CAS Number: 68693118
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Suffolk Mental Health Partnerships Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 be both be less than 8 for inclusion in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients should not currently fulfil criteria for mania, a mixed affective state, hypomania or major depression. 2) Patients should not score = 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) Patients should not have a current diagnosis of alcohol or drug dependence based on DSM IV criteria. 4) Patients should not have a history of learning disability (or Wechsler test of Adult Reading score <90) or dyslexia 5) Patients with any known neurological illness (including narcolepsy) will be excluded 6) Patients with unstable medical illness that may affect cognition (untreated thyroid disease, type I diabetes mellitus or current treatment with steroids) will be excluded. 7) Patients who have received electroconvulsive therapy in the past three months will be excluded.. 8) Patients taking herbal remedies such as St John’s Wort or Gingko Biloba will be excluded. 9) Subjects should not have moderate or severe hypertension. All patients should have blood pressure measurements within normal limits (i.e. systolic BP = 160 and diastolic BP = 90) prior to drug administration. 10) Patients will be excluded if they have a known history of angina or cardiac arrhythmias. 11) Subjects will be excluded if pregnant or breastfeeding 12) Patients taking phenytoin will be excluded because of a possible increase in plasma concentration. 13) Patients with a known hypersensitivity to modafinil or its excipients, or to the placebo will be excluded. 14) Patients who have participated in another clinical drug trial within the last three months will be excluded. 15) Female patients on an oral contraceptive (OC) will need to be counselled about the possibility that modafinil may reduce the effectiveness of the oral contraceptive. They will only be excluded if they are not willing to take the family planning advice recommendations in the BNF (March 49, 2005, page 402) (for the short term course of an enzyme inducing drug). 16) Patients should not have had any changes to their psychotropic drugs over the past 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether modafinil given acutely (one dose) improves cognitive impairment in bipolar patients in remission;Secondary Objective: ;Primary end point(s): Individual tests of attention, memory and executive function will be measured on modafinil and placebo. We will examine whether acute treatment with modafinil effects cognitive function relative to a placebo. | — |
Countries
United Kingdom
Outcome results
None listed