Phase 4 Completed N=508 Randomized Triple-blind Treatment

Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

Major Depressive Disorder

Source: ClinicalTrials.gov NCT01473394 ↗

Enrolled (actual)

508

Serious AEs

1.0%

Results posted

Apr 2014

Primary outcomePrimary: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 — -11.0; -16.1 Units on a scale — p=<0.00001

Summary

The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	-11.0; -16.1	<0.00001 sig
SECONDARY Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8	-1.2; -1.8	<0.00001 sig
SECONDARY Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate	17.1; 27.3	0.0047 sig

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.

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;
mental retardation, dementia, amnesia, or other cognitive disorders;
patients who are considered a suicide risk.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01473394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.