Efficacy and Safety Study of Desvenlafaxine in the Treatment of Vascular Depression

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hotel-Dieu Grace Healthcare
• Treatments: 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