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Effect of Antidepressants on White Matter Structure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
ClinicalTrials.gov Identifier:
NCT01492621
First received: December 12, 2011
Last updated: December 14, 2011
Last verified: December 2011

December 12, 2011
December 14, 2011
November 2011
September 2013   (final data collection date for primary outcome measure)
Anisotropy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
Same as current
Complete list of historical versions of study NCT01492621 on ClinicalTrials.gov Archive Site
  • cognitive measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    cognitive deficits will be measured at baseline and 16 weeks and correlated to anisotropy using computerized neuropsychological testing of memory, speed and executive function.
  • Pain threshold [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
Same as current
Not Provided
Not Provided
 
Effect of Antidepressants on White Matter Structure
White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study

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.

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.

Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Major Depression
Drug: Desvenlafaxine
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Other Name: Pristiq
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2013
September 2013   (final data collection date for primary outcome measure)

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) -
Both
18 Years to 55 Years
No
Contact: souad Lahlafi, BNurs 5142514000 ext 3416 slahlafi.crfs@ssss.gouv.qc.ca
Contact: Louise Normandeau, Nurs 5142514000 ext 3535 lnormandeau.hlhl@ssss.gouv.qc.ca
Canada
 
NCT01492621
DTI
No
Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Pfizer
Principal Investigator: Smadar V Tourjman, MDCM University of Montreal, Centre de recherche Fernand Seguin
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
December 2011

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