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Effect of Antidepressants on White Matter Structure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492621
First Posted: December 15, 2011
Last Update Posted: December 15, 2011
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
  Purpose
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.

Condition Intervention Phase
Major Depression Drug: Desvenlafaxine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study

Resource links provided by NLM:


Further study details as provided by Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:

Primary Outcome Measures:
  • Anisotropy [ Time Frame: 16 weeks ]
    Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status


Secondary Outcome Measures:
  • cognitive measures [ Time Frame: 16 weeks ]
    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 ]
    Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Desvenlafaxine
    Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
    Other Name: Pristiq
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) -
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01492621


Contacts
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

Locations
Canada, Quebec
Centre de Recherche Fernand-Seguin Recruiting
Montreal, Quebec, Canada, H1N3V2
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   
Sponsors and Collaborators
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Pfizer
Investigators
Principal Investigator: Smadar V Tourjman, MDCM University of Montreal, Centre de recherche Fernand Seguin
  More Information

Responsible Party: Valerie Tourjman, Associate director of clinical research, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
ClinicalTrials.gov Identifier: NCT01492621     History of Changes
Other Study ID Numbers: DTI
First Submitted: December 12, 2011
First Posted: December 15, 2011
Last Update Posted: December 15, 2011
Last Verified: December 2011

Keywords provided by Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:
major depression
DTI
inflammatory markers
cognition

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Desvenlafaxine Succinate
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs