Safety and Efficacy of Vilazodone in Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT01573598
• Date of registration: 04/04/2012
• Prospective Registration: No
• Primary sponsor: Forest Laboratories
• Public title: Safety and Efficacy of Vilazodone in Major Depressive Disorder
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
• Date of first enrolment: April 2012
• Target sample size: 1219
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01573598
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Bulgaria, Finland, Germany, Romania, Russian Federation, Serbia, Ukraine, United States

Contacts

• Name: Carrie Reichley
• Affiliation: Forest Research Institute, a subsidiary of Actavis plc.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Placebo

Drug: Vilazodone

Primary Outcome(s)

Time to first relapse during the double-blind treatment phase [Time Frame: Number of days from the randomization date to the relapse date, up to 28 weeks.]

Secondary ID(s)

VLZ-MD-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors