Major DepressionPhase 4NCT01492621
Effect of Antidepressants on White Matter Structure
A Phase 4 study testing Desvenlafaxine in people with Major Depression, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Desvenlafaxine
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depression
- Age 18 to 55
- Hamilton grater or equal to 20
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de Recherche Fernand-Seguin
Montreal, Quebec, H1N3V2
Souad Lahlafi, Bnurs, 5142514000 ext. 3416, slahlafi.crfs@ssss.gouv.qc.ca
Louise Normandeau, Nurs, 5142514000 ext. 3535, lnormandeau.hlhl@ssss.gouv.qc.ca
About this study
Official title: White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- Desvenlafaxine
- Keywords
- major depression, DTI, inflammatory markers, cognition
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Also called Pristiq
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anisotropy
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
Measured: 16 weeks
Secondary outcomes (2)
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.
Measured: 16 weeks
Pain threshold
Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Valerie Tourjman, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Investigators
- Smadar V Tourjman, MDCM, Principal investigator, University of Montreal, Centre de recherche Fernand Seguin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492621
- Sponsor's protocol ID
- DTI
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
- ClinicalTrials.gov ID
- NCT01492621
- Acronym / sponsor ID
- DTI
- Conditions
- Major Depression
- Keywords
- major depression, DTI, inflammatory markers, cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major depression
- Age 18 to 55
- Hamilton grater or equal to 20
Key exclusion criteria (6 listed)
- Major neurologic disorder
- Major cardiovascular disorder
- Unstable medical condition
- Significant psychiatric co-morbidity
- Current substance dependance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesvenlafaxineAlso: PristiqDesvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained. | Drug | – |
Primary outcome
Anisotropy
Time frame: 16 weeks
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
2 secondary outcomes
cognitive measures
Time frame: 16 weeks
Pain threshold
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smadar V Tourjman, MDCM principal investigator
University of Montreal, Centre de recherche Fernand Seguin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desvenlafaxine in people with Major Depression, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact souad Lahlafi, BNurs (5142514000 ext. 3416, slahlafi.crfs@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anisotropy (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.