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Depression and Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254007
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 28, 2017
Ontario Mental Health Foundation
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:

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 or disease Intervention/treatment Phase
Depression Traumatic Brain Injury Drug: citalopram (celexa) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury
Study Start Date : July 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram

Intervention Details:
  • Drug: citalopram (celexa)
    20(1 tablet)-50(2 1/2 tablets) mg/day for a period of 6 or 10 weeks

Primary Outcome Measures :
  1. - Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 6 weeks and 10 weeks (if applicable) ]

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00254007

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

Publications of Results:
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Responsible Party: Krista Lanctot, Sunnybrook Health Sciences Centre Identifier: NCT00254007     History of Changes
Other Study ID Numbers: 205-2003
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Sunnybrook Health Sciences Centre:
traumatic brain injury
serotonin transporter
genetic polymorphisms
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Depressive Disorder
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents