Safety and Efficacy of Vilazodone in Major Depressive Disorder (VLZ-MD-01)

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo to citalopram; Drug: Vilazodone; Drug: Citalopram; Drug: Placebo to vilazodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473381

VLZ-MD-01

Details and patient eligibility

About

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.

Enrollment: 1,162 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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1,162 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.

Treatment:

Drug: Placebo to vilazodone

Drug: Placebo to citalopram

Vilazodone 20 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Vilazodone

Drug: Placebo to vilazodone

Drug: Placebo to citalopram

Vilazodone 40 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Vilazodone

Drug: Placebo to vilazodone

Drug: Placebo to citalopram

Citalopram 40 mg/day

Active Comparator group

Description:

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.

Treatment:

Drug: Citalopram

Drug: Placebo to vilazodone