Depression and Traumatic Brain Injury

Plain-language summary

This study examines the effect of the drug citalopram on depression in people who have had a traumatic brain injury within the past two months. It enrolled people over 18 with mild to moderate traumatic brain injury, with one group also required to have a diagnosis of major depression. The research was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Sunnybrook Health Sciences Centre

Intervention

citalopram (celexa)

Start date

7/1/2003

Estimated completion

5/1/2010

Countries

Canada

Related genes

Locations

• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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