Overview
Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hotel-Dieu Grace HealthcareTreatments:
Desvenlafaxine Succinate
Criteria
Inclusion Criteria:1. 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.
2. Male or female subject between 60 and 80 years of age, at the time of consent.
3. Diagnosis of Major Depressive Disorder according to DSM-IV-TR at screening.
4. Evidence of DWMH on MRI
5. 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)
6. Subjects are willing and able to comply with scheduled visits, treatment plan, and
other study procedures
Exclusion Criteria:
1. Subjects who have a history of repeated non-compliance with treatment.
2. Subjects with any contraindication(s) to desvenlafaxine, in accordance with product
monograph
3. Subjects with known or suspected narrow angle glaucoma
4. Subjects currently being treated with anticoagulants
5. Subjects with known hypertension or uncontrolled diabetes
6. 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)
7. 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
8. Subjects with a diagnosis of a psychotic disorder or currently experiencing psychotic
symptoms
9. Subjects judged by the investigator as being at significant risk of
self-injurious/suicidal or violent/homicidal behavior
10. Subjects who have experienced symptoms of a CVA
11. Subjects with TIAs within the past 6 weeks