Depression and Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00254007
First received: November 10, 2005
Last updated: February 28, 2011
Last verified: September 2006
  Purpose

Problem: Depressive symptoms are a common mental health problem following traumatic brain injury (TBI), occurring in up to 87% of patients. Depression following TBI has important consequences including poor functioning, lack of ability to return to work and family activities and prolonged TBI symptoms. The reason depression develops in some patients following TBI is unknown, making treatment difficult.

One type of brain protein that shows genetic differences between people is called the serotonin transporter. People can be divided by whether or not they have a short protein (S allele) or a long protein (L allele) which influences the amount of serotonin transporter. Serotonin is a key brain chemical in depression in many mental/psychiatric illnesses. We think that the genetic differences in the serotonin transporter, that may not make a difference before TBI, may become important after TBI due to the nature of these injuries.

Methods: A consecutive sample of 200 patients attending a TBI clinic who have sustained a mild-to-moderate TBI (American Congress of Rehabilitation Medicine criteria) within the last 2 months will be assessed for the presence of major depression (standard criteria, standardized interview). In phase I, blood samples from patients with mild-to-moderate TBI with depression and without depression will be checked for the presence of the 5-HTTPR genetic difference. This will allow us to study if the S allele is more likely in TBI patients with depression. In phase II, the patients with depression will be treated with the SSRI citalopram for 6 weeks. At 6 weeks, or upon discontinuation of citalopram, depression will be assessed again. This will allow us to study if depressed patients with the S allele respond more poorly to treatment. Persons assessing depression after treatment will not know the genetic makeup of each patient.

Results Expected: If the serotonin transporter genetic difference confers susceptibility to depression following TBI, this will provide important information on what causes depression following TBI and document a risk factor for depression previously unstudied in this population. Also, as SSRI antidepressants are used to treat depression in TBI, this study may identify a subgroup of TBI patients in whom different medications should be given or additional medications are required.


Condition Intervention Phase
Depression
Traumatic Brain Injury
Drug: citalopram (celexa)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • - Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 6 weeks and 10 weeks (if applicable) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI), Rivermead Head Injury Follow-up Questionnaire (RHFQ), General Health Questionnaire (GHQ), Rivermead Post Concussion Disorder Questionnaire (RPDQ) [ Time Frame: Baseline, 6 weeks and 10 weeks (if applicable) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2003
Study Completion Date: May 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: citalopram (celexa)
    20(1 tablet)-50(2 1/2 tablets) mg/day for a period of 6 or 10 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years
  • gender: male or female
  • TBI within the last two months
  • mild to moderate TBI
  • written, informed consent
  • depressed group only: diagnosis of major depressive episode using the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)

Exclusion Criteria:

  • prior TBI or other focal brain disease (stroke, tumor)
  • 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 paralysis, brain tumor, subdural hematoma, multiple sclerosis
  • a brain CT scan revealing focal lesions that could not be interpreted as consistent with a TBI
  • depression group only: contraindications to receiving treatment with citalopram
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254007

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Ontario Mental Health Foundation
Investigators
Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Krista Lanctot, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00254007     History of Changes
Other Study ID Numbers: 205-2003
Study First Received: November 10, 2005
Last Updated: February 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
depression
traumatic brain injury
serotonin transporter
genetic polymorphisms
citalopram

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
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on April 17, 2014