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Trial record 26 of 154 for:    HTT

Depression and Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00254007
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by:
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE July 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
- Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 6 weeks and 10 weeks (if applicable) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
- Hamilton Depression Rating Scale (HAM-D)
Change History Complete list of historical versions of study NCT00254007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
  • - Beck Depression Inventory (BDI)
  • - Rivermead Head Injury Follow-up Questionnaire (RHFQ)
  • - General Health Questionnaire (GHQ)
  • - Rivermead Post Concussion Disorder Questionnaire (RPDQ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression and Traumatic Brain Injury
Official Title  ICMJE The Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Traumatic Brain Injury
Intervention  ICMJE Drug: citalopram (celexa)
20(1 tablet)-50(2 1/2 tablets) mg/day for a period of 6 or 10 weeks
Study Arms  ICMJE Not Provided
Publications * Chan F, Lanctôt KL, Feinstein A, Herrmann N, Strauss J, Sicard T, Kennedy JL, McCullagh S, Rapoport MJ. The serotonin transporter polymorphisms and major depression following traumatic brain injury. Brain Inj. 2008 Jun;22(6):471-9. doi: 10.1080/02699050802084886.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 10, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254007
Other Study ID Numbers  ICMJE 205-2003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krista Lanctot, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Ontario Mental Health Foundation
Investigators  ICMJE
Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP