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Desvenlafaxine for Depression
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 53 Patients • NCT01916824Trial Design
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- 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.
- Group 1: Desvenlafaxine Succinate
- 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.
- 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.
Frequently Asked Questions
Who has the privilege of participating in this research trial?
"This research venture is admitting 30 geriatric patients suffering from vascular depression. Suitable candidates must meet the following eligibility criteria: subjects that are willing to comply with study visits and procedures, have given informed consent for participation in this trial, aged 60-80 years old at time of signing up, diagnosed with Major Depressive Disorder according DSM IV TR, evidence of DWMH on MRI scans, cognitive deficits not meeting dementia diagnosis (MMSE 21 or higher and CDR=0.5)."
What is the current sample size of this research project?
"Unfortunately, active recruitment for this trial concluded on March 18th 2015. However, if you are searching for similar studies, there are currently 1287 trials actively enrolling patients with depression related to vascular issues and 2 distinct studies need participants taking Desvenlafaxine Succinate."
Has the FDA sanctioned Desvenlafaxine Succinate for public use?
"Due to the fact that Desvenlafaxine Succinate is an approved treatment, our evaluation gave it a score of 3 on the risk scale."
Are seniors accepted into this testing program?
"The requirements for this medical trial necessitate that applicants must be aged between 60 and 80 years old. There are 191 trials available to those under 18, while 964 can participate if they exceed the age of 65."
What other explorations have been done with Desvenlafaxine Succinate?
"Presently, two clinical trials involving Desvenlafaxine Succinate are underway. One of the active studies is in its third phase and takes place primarily around Windsor, Ontario with seven additional locations offering this medication as part of a trial."
Is this research pioneering in its methodology?
"Currently, two trials involving Desvenlafaxine Succinate are being conducted in four cities and two countries. This medication was first investigated by Jiangsu Hansoh Pharmaceutical Co., Ltd. in 2013; a Phase 2 & 3 drug approval program including 300 patients obtained the necessary data before concluding. Since its inception, 49 studies have concluded successfully."
Are there any remaining vacancies in this medical trial?
"As evidenced on clinicaltrials.gov, this study is no longer actively seeking participants; its initial posting was December 1st 2013 and the last update occurred March 18th 2015. Despite not recruiting anymore, there are still 1289 other studies that currently require volunteers."
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