Status:
UNKNOWN
Antidepressant Maintenance in Traumatic Brain Injury
Lead Sponsor:
Ontario Neurotrauma Foundation
Conditions:
Depression
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to explore to what extent continuing the antidepressant medication citalopram (Celexa), after depression has responded to treatment, helps prevent the return of depressive ...
Detailed Description
While antidepressants are effective in treating major depression following TBI, there is a lack of certainty as to how long antidepressants must be continued following improvement of symptoms. Many st...
Eligibility Criteria
Inclusion
- Age \> 18 years
- TBI within the last year (this is consistent with clinic population)
- Mild TBI
- Written, informed consent
- Diagnosis of major depressive episode using the depression module of the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-IV), and baseline 17-item Hamilton Depression (HAM-D) Rating Scale score of 16 and above (prior to selective serotonin reuptake inhibitor \[SSRI\] treatment)
- Response to citalopram 20 or 40mg/d, as defined as a reduction in baseline HAM-D of \>= 50%, and HAM-D score of 10 or below; or response to citalopram defined as not meeting DSM-IV criteria for major depression and Clinical Global Impression - severity of mildly ill, borderline ill, or normal and a Clinical Global Impression - improvement of much improved or very much improved impression.
Exclusion
- Prior TBI or other focal brain disease (e.g., stroke, tumour)
- 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 palsy; brain tumor; subdural hematoma; or multiple sclerosis.
- Current alcohol or substance abuse
- A brain computed tomographic (CT) scan revealing focal lesions that could not be interpreted as consistent with TBI
- Presence of premorbid psychiatric diagnosis of schizophrenia, dementia or bipolar disorder
- Prior episode of major depression in two years prior to TBI, based on SCID-IV interview
- Prior treatment with citalopram or contraindications to receiving treatment with citalopram
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00162916
Start Date
May 1 2005
End Date
October 1 2008
Last Update
June 4 2008
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5