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Esketamine Nasal Spray for Depression (SUSTAIN-3 Trial)
SUSTAIN-3 Trial Summary
This trial will test if esketamine is a safe and tolerable treatment for people with treatment-resistant depression.
- Depression
SUSTAIN-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 1148 Patients • NCT02782104SUSTAIN-3 Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What are the researchers trying to achieve with this experiment?
"Janssen Research & Development, LLC, the primary sponsor for this clinical trial, has announced that the primary outcome being measured over the course of the study is change in heart rate from baseline. This 5 year 3 month long study will also be evaluating secondary outcomes including changes in participant-reported health status, as assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale (VAS), Clinical Global Impression-Severity (CGI-S) score and Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ9) Total Score"
Are the methods used in this trial new or innovative?
"As of right now, there are 26 Esketamine Nasal Spray clinical trials happening in 95 cities and 31 countries. The first one started back in 2016 and was completed in the Phase 3 drug approval stage. Since then, 48 more studies have been conducted."
How many subjects are in this experiment?
"Currently, this trial is not recruiting patients. The study was originally posted on June 9th 2016 and the most recent update was October 12th 2022. However, there are other clinical trials that may be of interest; 1357 studies for patients with depressive disorder and 26 for those specifically interested in Esketamine Nasal Spray."
Has Esketamine Nasal Spray received regulatory approval from the FDA?
"Esketamine Nasal Spray is considered safe by our team at Power. This is due to the fact that it is a Phase 3 trial, meaning that there is evidence of its efficacy and multiple rounds of data supporting its safety."
In how many different medical clinics is this research being conducted today?
"There are 55 sites running this trial currently, with Boston, Wichita Falls and Ottawa among the locations. To reduce travel requirements, patients should try to enroll at the location nearest them."
Can you share what indications Esketamine Nasal Spray is most often prescribed for?
"Esketamine Nasal Spray is most frequently used to treat unipolar depression, but it has also been shown to help manage pain, status asthmaticus, and muscle relaxation."
Could you walk me through other scientific research that has been done on Esketamine Nasal Spray?
"Esketamine Nasal Spray was first studied in 2016 under the identifier NCT02782104. As of now, there have been 48 completed trials with 26 more presently active and recruiting patients. Most of these latter clinical studies are based out of Boston, Massachusetts."
Are we still recruiting people for this research project?
"This clinical trial is no longer actively recruiting patients, according to the information on clinicaltrials.gov. The study was first posted on June 9, 2016 and was last updated on October 12, 2022. However, there are 1383 other trials currently looking for participants that you may be eligible for."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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