Antidepressant Maintenance in Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Ontario Neurotrauma Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ontario Neurotrauma Foundation
ClinicalTrials.gov Identifier:
NCT00162916
First received: September 10, 2005
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Depression
Drug: citalopram
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Ontario Neurotrauma Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: May 2005
Estimated Study Completion Date: October 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Cornstarch
Experimental: 2 Drug: citalopram
20mg or 40mg, once daily, for 40 weeks
Other Name: Celexa

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Ontario Neurotrauma Foundation

Additional 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
Study First Received: September 10, 2005
Last Updated: June 3, 2008
Health Authority: Canada: Ethics Review Committee

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
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on August 21, 2014