Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162916
Status:
UNKNOWN
Last Update Posted:
2008-06-04
First Post:
2005-09-10
Brief Title:
Antidepressant Maintenance in Traumatic Brain Injury
Sponsor:
Ontario Neurotrauma Foundation
Organization:
Ontario Neurotrauma Foundation
Study Overview
Official Title:
A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 symptoms in patients with recent traumatic brain injury TBI
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None