Effect of Antidepressants on White Matter Structure

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01492621

Enrollment

Registered

2011-12-15

Start date

2011-11-30

Completion date

2013-11-30

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

major depression, DTI, inflammatory markers, cognition

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.

Interventions

DRUGDesvenlafaxine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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) -

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary Contactsouad Lahlafi, BNurs

slahlafi.crfs@ssss.gouv.qc.ca5142514000

Backup ContactLouise Normandeau, Nurs

lnormandeau.hlhl@ssss.gouv.qc.ca5142514000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026