Vascular Depression Clinical Trial
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment