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
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: December 12, 2011
Last Updated: December 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by 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
O-desmethylvenlafaxine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014