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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Dose-matched placebo; Drug: Vilazodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473394

VLZ-MD-03

Details and patient eligibility

About

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.

Enrollment: 518 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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518 participants in 2 patient groups, including a placebo group

Dose-matched placebo

Placebo Comparator group

Description:

Participants received dose-matched placebo orally once daily for 9 weeks.

Treatment:

Drug: Dose-matched placebo

Vilazodone

Experimental group

Description:

Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.

Treatment:

Drug: Vilazodone