Effect of Antidepressants on White Matter Structure
This study is currently recruiting participants.
Verified December 2011 by Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Sponsor:
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Collaborator:
Pfizer
Information provided by (Responsible Party):
Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
ClinicalTrials.gov Identifier:
NCT01492621
First received: December 12, 2011
Last updated: December 14, 2011
Last verified: December 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Major Depression |
Drug: Desvenlafaxine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:
Primary Outcome Measures:
- Anisotropy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
Secondary Outcome Measures:
- cognitive measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Desvenlafaxine
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Other Name: Pristiq
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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) -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492621
Contacts
| Contact: souad Lahlafi, BNurs | 5142514000 ext 3416 | slahlafi.crfs@ssss.gouv.qc.ca |
| Contact: Louise Normandeau, Nurs | 5142514000 ext 3535 | lnormandeau.hlhl@ssss.gouv.qc.ca |
Locations
| Canada, Quebec | |
| Centre de Recherche Fernand-Seguin | Recruiting |
| Montreal, Quebec, Canada, H1N3V2 | |
| Contact: Souad Lahlafi, Bnurs 5142514000 ext 3416 slahlafi.crfs@ssss.gouv.qc.ca | |
| Contact: Louise Normandeau, Nurs 5142514000 ext 3535 lnormandeau.hlhl@ssss.gouv.qc.ca | |
Sponsors and Collaborators
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Pfizer
Investigators
| Principal Investigator: | Smadar V Tourjman, MDCM | University of Montreal, Centre de recherche Fernand Seguin |
More Information
Additional Information:
No publications provided
| Responsible Party: | Valerie Tourjman, Associate director of clinical research, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine |
| ClinicalTrials.gov Identifier: | NCT01492621 History of Changes |
| Other Study ID Numbers: | DTI |
| Study First Received: | December 12, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine:
|
major depression DTI inflammatory markers cognition |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents O-desmethylvenlafaxine |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013