Effect of Antidepressants on White Matter Structure | NCT01492621

Studies
Effect of Antidepressants on White Matter Structure

NCT01492621

Sponsor

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

Status

Unknown status

Last Update Posted

Dec 15, 2011Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Major Depression

Interventions

Desvenlafaxine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Sep 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2011

Last Update Posted Date

Dec 15, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

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

Collaborators

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desvenlafaxine	Drug	Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.		Pristiq

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anisotropy	Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
cognitive measures	cognitive deficits will be measured at baseline and 16 weeks and correlated to anisotropy using computerized neuropsychological testing of memory, speed and executive function.	16 weeks
Pain threshold

Other Outcomes

Not provided

Eligibility Module

Eligibility 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) -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
souad Lahlafi, BNurs	Contact	5142514000	3416	slahlafi.crfs@ssss.gouv.qc.ca
Louise Normandeau, Nurs	Contact	5142514000	3535	lnormandeau.hlhl@ssss.gouv.qc.ca

Overall Officials

Name	Affiliation	Role
Smadar V Tourjman, MDCM	University of Montreal, Centre de recherche Fernand Seguin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche Fernand-Seguin	Recruiting	Montreal	Quebec	H1N3V2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069468	Desvenlafaxine Succinate

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided