Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT01974934
Status:
UNKNOWN
Last Update Posted:
2015-03-19
First Post:
2013-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
Sponsor:
Hotel-Dieu Grace Healthcare
Organization:
Study Overview
Official Title:
A 12 Week, Open Label, Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: