Antidepressant Maintenance in Traumatic Brain Injury
Recruitment status was Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury|
- recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
- general cognitive function at baseline, 10 weeks and on termination of the trial [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
- list of adverse drug events at baseline, 10 weeks and on termination of the trial [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||October 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
20mg or 40mg, once daily, for 40 weeks
Other Name: Celexa
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 studies published in the last decade strongly show that antidepressants prevent relapse in patients with major depression in the absence of traumatic brain injury (TBI). However, is it unknown as to whether this is the case following TBI. The aim of this study is to determine whether being on an antidepressant for a year reduces the risk of relapse of depression.
Patients diagnosed with major depression following mild TBI will be treated for ten weeks with the antidepressant drug citalopram. Those who respond, meaning that the symptoms of depression have lessened significantly, will be randomly assigned to either continue taking the citalopram for one year or to take a placebo for one year. Every four weeks, for an additional forty weeks, patients will be assessed for relapse of depression. This study will have a double-blind design, meaning that neither patient nor clinician know whether citalopram or placebo is being administered.
The primary outcome of interest will be a comparison of the percentage of patients who have a recurrence of major depression while continued on citalopram compared with those who were switched to placebo after the acute phase. Recurrence will be defined as meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depression and a Hamilton Depression Scale (HAM-D) score of > 16. Or meeting DSM-IV criteria for major depression and having a Clinical Global Impression (CGI) severity score of >= 4 and a CGI illness score of >= 3. The HAM-D and CGI will be administered every four weeks for forty weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162916
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Mark J Rapoport, MD, FRCPC||Sunnybrook Health Sciences Centre, University of Toronto|