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Safety and Efficacy of Vilazodone in Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01573598
Enrollment
1219
Registered
2012-04-09
Start date
2012-04-30
Completion date
2015-01-31
Last updated
2015-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, Depression

Brief summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Interventions

DRUGPlacebo

Matching placebo given orally, once per day

DRUGVilazodone

Vilazodone, 20 mg per day, oral administration

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Men and women, 18-70 years of age * Currently meet the 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 18 months in duration

Exclusion criteria

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control * Patients with a history of meeting DSM-IV-TR criteria for: * any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode; * any depressive episode with psychotic or catatonic features; * panic disorder with or without agoraphobia; * obsessive-compulsive disorder; * Schizophrenia, schizoaffective, or other psychotic disorder; * bulimia or anorexia nervosa; * presence of borderline personality disorder or antisocial personality disorder; h. mental retardation, dementia, amnesia, or other cognitive disorders * Patients who are considered a suicide risk

Design outcomes

Primary

MeasureTime frame
Time to first relapse during the double-blind treatment phaseNumber of days from the randomization date to the relapse date, up to 28 weeks.

Countries

Bulgaria, Finland, Germany, Romania, Russia, Serbia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026