Enhancing cognition in bipolar disorder - Enhancing cognition in bipolar disorder

Suffolk Mental Health Partnerships Trust0 sites20 target enrollmentJune 13, 2005

Overview

No summary available.

Registry

who.int

Start Date

June 13, 2005

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Suffolk Mental Health Partnerships Trust

•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

•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.