E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bipolar affective disorder, currently in remission |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine whether modafinil given acutely (one dose) improves cognitive impairment in bipolar patients in remission |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
proof of concept study examining effects on cognition |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patients will receive one dose of modafinil or placebo in a crossover double-blind design. The second test session will be a minimum of one week apart (but a maximum of six months apart). The study will then be complete. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |