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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00254007 |
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Date of registration:
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10/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Depression and Traumatic Brain Injury
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Scientific title:
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The Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00254007 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Krista L Lanctot, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sunnybrook Health Sciences Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Traumatic Brain Injury
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Depression
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Intervention(s)
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Drug: citalopram (celexa)
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Primary Outcome(s)
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- Hamilton Depression Rating Scale (HAM-D)
[Time Frame: Baseline, 6 weeks and 10 weeks (if applicable)]
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Secondary Outcome(s)
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Beck Depression Inventory (BDI), Rivermead Head Injury Follow-up Questionnaire (RHFQ), General Health Questionnaire (GHQ), Rivermead Post Concussion Disorder Questionnaire (RPDQ)
[Time Frame: Baseline, 6 weeks and 10 weeks (if applicable)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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