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Serotonin-Norepinephrine Reuptake Inhibitor
Desvenlafaxine for Depression
Phase 4
Waitlist Available
Led By Corina Velehorschi, MD
Research Sponsored by Hotel-Dieu Grace Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Subjects with known or suspected narrow angle glaucoma
Subjects currently being treated with anticoagulants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
Summary
This trial will examine whether desvenlafaxine is an effective treatment for vascular depression, as well as assessing its safety. The primary efficacy measures will be depressive symptoms and cognition, both measured at baseline and 12 weeks. A sub-group of patients who have experienced a TIA will also be evaluated for efficacy.
Who is the study for?
This trial is for individuals aged 60-80 with Major Depressive Disorder and cognitive deficits, but not dementia. They must have white matter changes on MRI and be able to follow the study plan. Excluded are those non-compliant with treatments, with contraindications to desvenlafaxine, glaucoma, recent TIAs or strokes, current anticoagulant use, uncontrolled diabetes or hypertension.Check my eligibility
What is being tested?
The trial tests desvenlafaxine's effectiveness in treating vascular depression over a period of 12 weeks. It measures changes in depression severity using the Geriatric Depression Scale and cognitive function using the Montreal Cognitive Assessment.See study design
What are the potential side effects?
Desvenlafaxine may cause nausea, dizziness, insomnia, sweating, constipation and possible sexual side effects. It can also increase blood pressure and has a risk of causing serotonin syndrome when combined with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 80 years old.
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I have been diagnosed with Major Depressive Disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or might have narrow angle glaucoma.
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I am currently on blood thinners.
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I am not taking SSRIs, SNRIs, or antipsychotic medications other than those being studied.
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I am not allergic or sensitive to desvenlafaxine.
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I have had symptoms of a stroke.
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I have high blood pressure or diabetes that is not well-controlled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depressive Symptoms
Side effects data
From 2015 Phase 4 trial • 53 Patients • NCT0191682421%
Headache
17%
Insomnia
13%
Upper Respiratory Tract Infection
8%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Major Depressive Disorder
Healthy Controls
Trial Design
1Treatment groups
Experimental Treatment
Group I: Desvenlafaxine SuccinateExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desvenlafaxine
FDA approved
Find a Location
Who is running the clinical trial?
Hotel-Dieu Grace HealthcareLead Sponsor
Corina Velehorschi, MDPrincipal InvestigatorHotel-Dieu Grace Healthcare
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have narrow angle glaucoma.I am currently on blood thinners.You have a diagnosis of a mental health condition other than Major Depressive Disorder, except for certain cognitive disorders.You have been diagnosed with a mental illness that causes you to lose touch with reality, or you are currently experiencing symptoms like hearing voices or seeing things that aren't there.I am not taking SSRIs, SNRIs, or antipsychotic medications other than those being studied.I am between 60 and 80 years old.I have been diagnosed with Major Depressive Disorder.You do not have significant memory or thinking problems that meet the criteria for dementia.You have white matter changes in your brain as seen on an MRI.You have a history of not following the treatment plan.I am not allergic or sensitive to desvenlafaxine.I have had symptoms of a stroke.The doctor thinks you might hurt yourself or someone else.I have had a mini-stroke in the last 6 weeks.I have high blood pressure or diabetes that is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Desvenlafaxine Succinate
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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