A Randomised Controlled Trial of the effects of donepezil on cognitive, behavioural, and functional outcome in traumatic brain injury

Completed

• Conditions: Traumatic Brain Injury (TBI); Injury, Occupational Diseases, Poisoning; Intracranial injury

• Registration Number: ISRCTN16354639
• Lead Sponsor: Baycrest Centre for Geriatric Care (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. History of head trauma resulting from contact forces or an acceleration/deceleration event
2. Aged 18 - 55 years, either sex
3. At least 6 months post injury
4. Cognitive complaints or cognitive impairment as assessed by the treating clinician
5. Objective evidence of cognitive impairment in the realm of attention, memory, or executive functioning
6. Outpatient status
7. Able to identify a caregiver
8. Consent granted by subjects NOT deemed incompetent to do so OR consent given by substitute decision maker to participate in the study

Exclusion Criteria

1. History of other central nervous system injury or disease (e.g. Alzheimer?s disease)
2. Relative contradictions for donepezil (including uncontrolled diabetes, current peptic ulcer, glaucoma etc.)
3. History of ongoing alcohol or drug abuse
4. Current Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) axis I diagnosis of schizophrenia, bipolar disorder, or untreated depression
5. Physical or language impediments to completion of the measures
6. Concurrent of benzodiazepines, all antidepressants (with the exception of selective serotonin re-uptake inhibitors [SSRIs], which will be allowed), neuroleptics, and/or anticholinergic medications
7. Persistent post traumatic amnesia, as defined by a Galveston orientation and amnesia test (GOAT) score of 75 or less at the time of study
8. Age <18 or Age >55
9. Not in agreement to use acceptable contraception
10. Performance below 9 on the forced-choice component of the 21 item test
11. Performance of 85 or above (index score) in each construct of the RBANS test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episodic verbal learning and memory measured at six months.

Secondary Outcome Measures

Name	Time	Method
1. Information processing speed at two and six months<br>2. Attention at two and six months<br>3. Problem solving at two and six months<br>4. Behaviour at two and six months<br>5. Affect at two and six months<br>6. Daily functioning at two and six months<br>7. Quality of life at two and six months