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Serotonin Modulator and Stimulator
Vortioxetine for 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
Study Summary
This placebo-controlled study is designed to determine the efficacy, safety, and tolerability of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized to receive vortioxetine and the other half will receive placebo.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Global Impression of Improvement (CGI-I) Responder Rate
Secondary outcome measures
Change in total Liebowitz Social Anxiety Scale (LSAS) score
Change in total Montgomery Asberg Depression Rating Scale (MADRS) score
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
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
Frequently Asked Questions
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