NCT01974934

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

October 23, 2013

Last Update Submit

March 18, 2015

Conditions

Vascular Depression

Outcome Measures

Primary Outcomes (1)

  • 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.

    12-weeks

Study Arms (1)

Desvenlafaxine Succinate

EXPERIMENTAL
Drug: Desvenlafaxine Succinate

Interventions

Desvenlafaxine SuccinateDRUG
Also known as: Pristiq
Desvenlafaxine Succinate

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel-Dieu Grace Healthcare

Windsor, Ontario, N9C 3Z4, Canada

RECRUITING

MeSH Terms

Conditions

Vascular Depression

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Study Officials

  • Corina Velehorschi, MD

    Hotel-Dieu Grace Healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Geml

CONTACT

519-257-5111jeff.geml@hdgh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRPC

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2016

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

CA(1)