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Selective Serotonin Reuptake Inhibitor (SSRI)

Vilazodone 10mg for Depression

Phase 3
Waitlist Available
Led By Ashwin A Patkar, MD
Research Sponsored by Duke University
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 baseline, week 9
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)
Change in Total MADRS Scores From Baseline to Week 8
Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)
Secondary study objectives
Change in Clinical Global Impression-Improvement (CGI-I) Scale
Change in Clinical Global Impression-Severity (CGI-S) Scale
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
+3 more

Side effects data

From 2017 Phase 4 trial • 24 Patients • NCT01999920
46%
Lightheadedness
46%
Increased Appetite
46%
Headache
38%
Dry Mouth
38%
Insomnia
38%
Impaired Concentration
31%
Diarrhea/Gas
31%
Sexual Dysfunction (women)
31%
Nausea
31%
Decreased Appetite
23%
Restlessness
23%
Fatigue
23%
Heartburn
23%
Apathy
15%
Excessive Sweating
15%
Somnolence
15%
Decreased Libido (men)
15%
Sexual Dysfunction (men)
8%
Tremor
8%
Forgetfulness
8%
Blurry Vision
8%
Skin Problems
8%
Impaired Coordination
8%
Decreased Libido (women)
8%
Constipation
8%
Nervousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vilazodone
Placebo

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.
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Vilazodone 40mgExperimental Treatment1 Intervention
vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Group II: Vilazodone 20mgExperimental Treatment1 Intervention
vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Group III: Vilazodone 10mgExperimental Treatment1 Intervention
Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vilazodone
FDA approved

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,009 Total Patients Enrolled
76 Trials studying Depression
39,185 Patients Enrolled for Depression
Ashwin A Patkar, MDPrincipal InvestigatorDuke University Health Systems
4 Previous Clinical Trials
146 Total Patients Enrolled
1 Trials studying Depression
60 Patients Enrolled for Depression
~5 spots leftby Nov 2025