Vascular DepressionPhase 4NCT01974934
Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
A Phase 4 study testing Desvenlafaxine Succinate in people with Vascular Depression, run by Hotel-Dieu Grace Healthcare at 1 site in Canada.
Trial summary
To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression. Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression Scale. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Vascular Depression
- What is being tested?
- Desvenlafaxine Succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Apr 2016
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Male or female subject between 60 and 80 years of age, at the time of consent.
- Diagnosis of Major Depressive Disorder according to DSM-IV-TR at screening.
- Evidence of DWMH on MRI
- Cognitive deficits not meeting criteria for dementia (MMSE higher or equal 21, Clinical Dementia Rating CDR=0.5, not meeting criteria on DSM IV TR)
- Subjects are willing and able to comply with scheduled visits, treatment plan, and other study procedures
Who cannot join
- Subjects who have a history of repeated non-compliance with treatment.
- Subjects with any contraindication(s) to desvenlafaxine, in accordance with product monograph
- Subjects with known or suspected narrow angle glaucoma
- Subjects currently being treated with anticoagulants
- Subjects with known hypertension or uncontrolled diabetes
- Subjects who meet criteria for an active DSM-IV-TR Axis I diagnosis other than Major Depressive Disorder (Cognitive Disorder NOS is permitted but not dementia)
Show all 11Show fewer
- Subjects prescribed any Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake inhibitors (SNRIs), or typical or atypical antipsychotic medications other than the medications being studied
- Subjects with a diagnosis of a psychotic disorder or currently experiencing psychotic symptoms
- Subjects judged by the investigator as being at significant risk of self-injurious/suicidal or violent/homicidal behavior
- Subjects who have experienced symptoms of a CVA
- Subjects with TIAs within the past 6 weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hotel-Dieu Grace Healthcare
Windsor, Ontario, N9C 3Z4
Jeff Geml, jeff.geml@hdgh.org
Corina Velehorschi, MD
About this study
Official title: A 12 Week, Open Label, Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression. Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment and analysis of change between baseline and 12-week scores.
To evaluate the effectiveness of desvenlafaxine as a first-line treatment for vascular depression in a sub-group of patients who have experienced a TIA greater than 6 weeks prior to baseline. Mean differences between baseline and 12-week efficacy measures will be examined within the sub-group.
Read the detailed description
The trial will involve 30 subjects (N=30). The study population is defined on the basis of the broader concept of vascular depression, but not including post stroke depression (PSD). Vascular depression (VaD) is described in patients of age equal or greater than 60 years with clinical symptoms of MDD, evidence of deep white matter hyperintensities (DWMH) on MRI and cognitive deficits not meeting criteria for dementia (based on a score equal or less than 21 on MMSE and 0.5 on CDR).
Upon completion of a screening assessment subjects will begin treatment with desvenlafaxine. For subjects who are currently prescribed an alternate SSRI or SNRI, they will be titrated off their current medication and begin desvenlafaxine, according to the clinical judgment of the investigator based on proven best practices. All subjects will begin on a dose of 50 mg of desvenlafaxine and after 4 weeks of active treatment may be titrated up to 100 mg daily. At the 8-week visit, individuals assessed as partial-responders, in the judgment of the investigator, may be titrated up to 150 mg daily. Personal clinical experience of the principal investigator has shown desvenlafaxine can be safely increased above a dose of 100 mg daily in partially responsive patients. The decision to titrate is based on a risk benefit analysis, as 150 mg is shown to be effective with limited side effects in younger patient populations. The principal investigator is comfortable with a daily dosage of 150mg and will assess for potential side effects. Blood pressure will be monitored at baseline and every 4 weeks as there is evidence that an increase in these values is more likely with dose escalation. It is estimated that 5-15% of the 30 patients may require 150 mg of desvenlafaxine as partial or non-responders to 100 mg daily. Patients prescribed 150mg desvenlafaxine and requiring downward titration will move to 100mg/d for 7 days, then 50mg/d for 7 days, followed by 50mg every other day for 7 days before discontinuation. Patients prescribed 50mg/d or 100mg/d will undergo similar downward titration prior to study drug discontinuation.
A baseline assessment will be conducted on all subjects, followed by assessments at week 4, 8, and a close out assessment at week 12. Additionally, enrolled subjects will undergo an MRI of the head, unless MRI results within the past 6 weeks can be made available, to confirm the presence or absence of DWMH.
- Conditions
- Vascular Depression
- Being tested
- Desvenlafaxine Succinate
- Medical subject headings
- Vascular Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine SuccinateDrug
Also called Pristiq
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine Succinate | Experimental | Not described Receives: Drug: Desvenlafaxine Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression. Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment and analysis of change between baseline and 12-week scores.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel-Dieu Grace Healthcare
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Corina Velehorschi, Hotel-Dieu Grace Healthcare
- Investigators
- Corina Velehorschi, MD, Principal investigator, Hotel-Dieu Grace Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974934
- Sponsor's protocol ID
- Pristiq-2013
- Status last verified
- Mar 2015
- First submitted
- 23 Oct 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week, Open Label, Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
- ClinicalTrials.gov ID
- NCT01974934
- Acronym / sponsor ID
- Pristiq-2013
- Conditions
- Vascular Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hotel-Dieu Grace HealthcareOther government
- Study start
- Dec 2013
- Primary completion
- Apr 2016 (estimated)
- First posted
- 4 Nov 2013 (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.
To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression. Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment and analysis of change between baseline and 12-week scores.
To evaluate the effectiveness of desvenlafaxine as a first-line treatment for vascular depression in a sub-group of patients who have experienced a TIA greater than 6 weeks prior to baseline. Mean differences between baseline and 12-week efficacy measures will be examined within the sub-group.
Detailed description
The trial will involve 30 subjects (N=30). The study population is defined on the basis of the broader concept of vascular depression, but not including post stroke depression (PSD). Vascular depression (VaD) is described in patients of age equal or greater than 60 years with clinical symptoms of MDD, evidence of deep white matter hyperintensities (DWMH) on MRI and cognitive deficits not meeting criteria for dementia (based on a score equal or less than 21 on MMSE and 0.5 on CDR).
Upon completion of a screening assessment subjects will begin treatment with desvenlafaxine. For subjects who are currently prescribed an alternate SSRI or SNRI, they will be titrated off their current medication and begin desvenlafaxine, according to the clinical judgment of the investigator based on proven best practices. All subjects will begin on a dose of 50 mg of desvenlafaxine and after 4 weeks of active treatment may be titrated up to 100 mg daily. At the 8-week visit, individuals assessed as partial-responders, in the judgment of the investigator, may be titrated up to 150 mg daily. Personal clinical experience of the principal investigator has shown desvenlafaxine can be safely increased above a dose of 100 mg daily in partially responsive patients. The decision to titrate is based on a risk benefit analysis, as 150 mg is shown to be effective with limited side effects in younger patient populations. The principal investigator is comfortable with a daily dosage of 150mg and will assess for potential side effects. Blood pressure will be monitored at baseline and every 4 weeks as there is evidence that an increase in these values is more likely with dose escalation. It is estimated that 5-15% of the 30 patients may require 150 mg of desvenlafaxine as partial or non-responders to 100 mg daily. Patients prescribed 150mg desvenlafaxine and requiring downward titration will move to 100mg/d for 7 days, then 50mg/d for 7 days, followed by 50mg every other day for 7 days before discontinuation. Patients prescribed 50mg/d or 100mg/d will undergo similar downward titration prior to study drug discontinuation.
A baseline assessment will be conducted on all subjects, followed by assessments at week 4, 8, and a close out assessment at week 12. Additionally, enrolled subjects will undergo an MRI of the head, unless MRI results within the past 6 weeks can be made available, to confirm the presence or absence of DWMH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine Succinate | Experimental | Drug: Desvenlafaxine Succinate |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Male or female subject between 60 and 80 years of age, at the time of consent.
- Diagnosis of Major Depressive Disorder according to DSM-IV-TR at screening.
- Evidence of DWMH on MRI
- Cognitive deficits not meeting criteria for dementia (MMSE higher or equal 21, Clinical Dementia Rating CDR=0.5, not meeting criteria on DSM IV TR)
Key exclusion criteria (11 listed)
- Subjects who have a history of repeated non-compliance with treatment.
- Subjects with any contraindication(s) to desvenlafaxine, in accordance with product monograph
- Subjects with known or suspected narrow angle glaucoma
- Subjects currently being treated with anticoagulants
- Subjects with known hypertension or uncontrolled diabetes
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 |
|---|---|---|
| Desvenlafaxine SuccinateAlso: Pristiq | Drug | Desvenlafaxine Succinate |
Primary outcome
Depressive Symptoms
Time frame: 12-weeks
To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression. Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment and analysis of change between baseline and 12-week scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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.
Corina Velehorschi, MD principal investigator
Hotel-Dieu Grace Healthcare
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 Succinate in people with Vascular Depression, run by Hotel-Dieu Grace Healthcare 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 6 inclusion and 11 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 19 Mar 2015. 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 Jeff Geml (519-257-5111 ext. 76908, jeff.geml@hdgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: 12-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 19 Mar 2015.