Effect of Antidepressants on White Matter Structure

NCT01492621

Last updated date
Study Location
Centre de Recherche Fernand-Seguin
Montreal, Quebec, H1N3V2, Canada
Contact
5142514000

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Major depression

- Age 18 to 55

- Hamilton grater or equal to 20

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Major neurologic disorder


- Major cardiovascular disorder


- Unstable medical condition


- Significant psychiatric co-morbidity


- Current substance dependance


- Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more
antidepressant treatments (adequate dose and duration) -

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Antidepressants on White Matter Structure
Official Title  ICMJE White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
Brief Summary Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.
Detailed Description 40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Major Depression
Intervention  ICMJE Drug: Desvenlafaxine
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Other Name: Pristiq
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 14, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Major depression
  • Age 18 to 55
  • Hamilton grater or equal to 20

Exclusion Criteria:

  • Major neurologic disorder
  • Major cardiovascular disorder
  • Unstable medical condition
  • Significant psychiatric co-morbidity
  • Current substance dependance
  • Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (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 NCT01492621
Other Study ID Numbers  ICMJE DTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Study Sponsor  ICMJE Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Smadar V Tourjman, MDCMUniversity of Montreal, Centre de recherche Fernand Seguin
PRS Account Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Verification Date December 2011

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