Status:
COMPLETED
Depression and Traumatic Brain Injury
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Ontario Mental Health Foundation
Conditions:
Depression
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Problem: Depressive symptoms are a common mental health problem following traumatic brain injury (TBI), occurring in up to 87% of patients. Depression following TBI has important consequences includin...
Eligibility Criteria
Inclusion
- age \>18 years
- gender: male or female
- TBI within the last two months
- mild to moderate TBI
- written, informed consent
- depressed group only: diagnosis of major depressive episode using the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)
Exclusion
- prior TBI or other focal brain disease (stroke, tumor)
- significant acute medical illness, including: drug overdose, severely disturbed liver, kidney, lung, or heart function, anemia, hypothyroidism, uncontrolled diabetes, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis
- a brain CT scan revealing focal lesions that could not be interpreted as consistent with a TBI
- depression group only: contraindications to receiving treatment with citalopram
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00254007
Start Date
July 1 2003
End Date
May 1 2010
Last Update
April 28 2017
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5