Overview

Antidepressant Maintenance in Traumatic Brain Injury

Status:
Unknown status
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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 symptoms in patients with recent traumatic brain injury (TBI).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ontario Neurotrauma Foundation
Treatments:
Antidepressive Agents
Citalopram
Dexetimide
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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