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Antidepressant Maintenance in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00162916
Recruitment Status : Unknown
Verified June 2008 by Ontario Neurotrauma Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 13, 2005
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
Ontario Neurotrauma Foundation

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).

Condition or disease Intervention/treatment Phase
Depression Drug: citalopram Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Antidepressant Maintenance for Major Depression Following Mild Traumatic Brain Injury
Study Start Date : May 2005
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : October 2008


Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Cornstarch

Experimental: 2 Drug: citalopram
20mg or 40mg, once daily, for 40 weeks
Other Name: Celexa




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. general cognitive function at baseline, 10 weeks and on termination of the trial [ Time Frame: 40 weeks ]
  2. list of adverse drug events at baseline, 10 weeks and on termination of the trial [ Time Frame: 40 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162916


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Mark J Rapoport, MD, FRCPC Sunnybrook Health Sciences Centre, University of Toronto

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark J Rapoport, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00162916     History of Changes
Other Study ID Numbers: rapoportm-ONF2004-abi-dep-03
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by Ontario Neurotrauma Foundation:
Traumatic Brain Injury
Depression
Antidepressant medication
Double-Blind Study
Brain Injuries
Antidepressive Agents
Citalopram
Double-Blind Method

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Brain Injuries, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents