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Effect of Antidepressants on White Matter Structure

NCT ID: NCT01492621

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Major Depression

Keywords

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major depression DTI inflammatory markers cognition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Desvenlafaxine

Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.

Intervention Type DRUG

Other Intervention Names

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Pristiq

Eligibility Criteria

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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) -
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Valerie Tourjman

Associate director of clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Smadar V Tourjman, MDCM

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Centre de recherche Fernand Seguin

Locations

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Centre de Recherche Fernand-Seguin

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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souad Lahlafi, BNurs

Role: CONTACT

Phone: 5142514000

Email: [email protected]

Louise Normandeau, Nurs

Role: CONTACT

Phone: 5142514000

Email: [email protected]

Facility Contacts

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Souad Lahlafi, Bnurs

Role: primary

Louise Normandeau, Nurs

Role: backup

Other Identifiers

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DTI

Identifier Type: -

Identifier Source: org_study_id