Effect of Antidepressants on White Matter Structure

Sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal (Other)

Overall Status

Unknown status

CT.gov ID

NCT01492621

Collaborator

Pfizer (Industry)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression	Drug: Desvenlafaxine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

Nov 1, 2013

Outcome Measures

Primary Outcome Measures

Anisotropy [16 weeks]
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status

Secondary Outcome Measures

cognitive measures [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 [16 weeks]
Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche Fernand-Seguin	Montreal	Quebec	Canada	H1N3V2

Sponsors and Collaborators

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Pfizer

Investigators

Principal Investigator: Smadar V Tourjman, MDCM, University of Montreal, Centre de recherche Fernand Seguin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Valerie Tourjman, Associate director of clinical research, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

ClinicalTrials.gov Identifier:

NCT01492621

Other Study ID Numbers:

First Posted:

Dec 15, 2011

Last Update Posted:

Dec 15, 2011

Last Verified:

Dec 1, 2011

Keywords provided by Valerie Tourjman, Associate director of clinical research, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Additional relevant MeSH terms:

Depression

Depressive Disorder

Depressive Disorder, Major

Desvenlafaxine Succinate

Study Results

No Results Posted as of Dec 15, 2011