Effect of Antidepressants on White Matter Structure

Major Depression Clinical Trial

Official title:

White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01492621
• Other study ID #: DTI
• Status: Recruiting
• Phase: Phase 4
• First received: December 12, 2011
• Last updated: December 14, 2011
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2011
• Source: Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
• Contact: souad Lahlafi, BNurs
• Phone: 5142514000
• Email: slahlafi.crfs[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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) -

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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

Locations

Country	Name	City	State
Canada	Centre de Recherche Fernand-Seguin	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anisotropy	Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status	16 weeks	No
Secondary	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	No
Secondary	Pain threshold	Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy	16 weeks	No

External Links

•   webpage of the Centre de Recherche Fernand-Seguin