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
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 12, 2011 | ||||||||
| Last Updated Date | December 14, 2011 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01492621 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Antidepressants on White Matter Structure | ||||||||
| Official Title ICMJE | White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Major Depression | ||||||||
| Intervention ICMJE | Drug: Desvenlafaxine
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Other Name: Pristiq |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01492621 | ||||||||
| Other Study ID Numbers ICMJE | DTI | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Valerie Tourjman, Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine | ||||||||
| Study Sponsor ICMJE | Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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