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Serotonin Modulator and Stimulator
Vortioxetine Versus Placebo in Major Depressive Disorder Comorbid With Social Anxiety Disorder
Phase 4
Waitlist Available
Led By Michael R Liebowitz, M.D.
Research Sponsored by The Medical Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing vortioxetine, a medication that may help adults who have both major depression and social anxiety. It works by balancing brain chemicals to improve mood and reduce anxiety. Vortioxetine is a new antidepressant approved by the US FDA for the treatment of major depressive disorder (MDD).
Eligible Conditions
- Social Anxiety Disorder
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression of Improvement (CGI-I) Responder Rate
Side effects data
From 2019 Phase 4 trial • 1106 Patients • NCT0237198026%
Nausea
8%
Headache
5%
Nasopharyngitis
5%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label: Vortioxetine 10 mg
Double-blind: Placebo
Double-blind: Vortioxetine 5 mg
Double-blind: Vortioxetine 10 mg
Double-blind: Vortioxetine 20 mg
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VortioxetineExperimental Treatment1 Intervention
Vortioxetine 10 to 20 mg PO QD for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo PO QD for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vortioxetine
FDA approved
Find a Location
Who is running the clinical trial?
The Medical Research NetworkLead Sponsor
5 Previous Clinical Trials
270 Total Patients Enrolled
Michael R Liebowitz, M.D.Principal InvestigatorThe Medical Research Network, LLC