Safety and Efficacy of Vilazodone in Major Depressive Disorder
(VLZ-MD-01 Trial)
Recruiting in Palo Alto (17 mi)
+53 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Forest Laboratories
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.
Research Team
CG
Carl Gommoll, MS
Principal Investigator
Forest Laboratories
Eligibility Criteria
Inclusion Criteria
Men and women, 18-70 years of age.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.
Treatment Details
Interventions
- Citalopram (Selective Serotonin Reuptake Inhibitor (SSRI))
- Placebo to Citalopram (Placebo)
- Placebo to Vilazodone (Placebo)
- Vilazodone (Serotonin Reuptake Inhibitor and 5-HT1A Receptor Partial Agonist)
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vilazodone 40 mg/dayExperimental Treatment3 Interventions
Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
Group II: Vilazodone 20 mg/dayExperimental Treatment3 Interventions
Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
Group III: Citalopram 40 mg/dayActive Control2 Interventions
Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
Group IV: PlaceboPlacebo Group2 Interventions
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Forest Laboratories
Lead Sponsor
Trials
338
Recruited
89,200+
Founded
1956
Headquarters
New York City, USA
Known For
Depression Medications
Top Products
> Celexa, Lexapro, Namenda, Savella
Brent Saunders
Forest Laboratories
Chief Executive Officer since 2013
JD and MBA from Temple University
Marco Taglietti
Forest Laboratories
Chief Medical Officer since 2013
MD