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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Vilazodone
Drug: Placebo to citalopram
Drug: Placebo to vilazodone
Drug: Citalopram
Phase 4

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
Official Title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
    The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.


Secondary Outcome Measures:
  • Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
    The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: "Considering your total clinical experience with this population, how mentally ill is the patient at this time?" The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.

  • Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
    The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.


Enrollment: 1162
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Drug: Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Other Name: Celexa
Drug: Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Experimental: Vilazodone 20 mg/day
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.
Drug: Vilazodone
Vilazodone was supplied as film-coated tablets.
Other Name: Viibryd
Drug: Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Other Name: Celexa
Drug: Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Experimental: Vilazodone 40 mg/day
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.
Drug: Vilazodone
Vilazodone was supplied as film-coated tablets.
Other Name: Viibryd
Drug: Placebo to citalopram
Placebo to citalopram was supplied as a capsule.
Other Name: Celexa
Drug: Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Active Comparator: Citalopram 40 mg/day
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.
Drug: Placebo to vilazodone
Placebo to vilazodone was supplied as film-coated tablets.
Drug: Citalopram
Citalopram was supplied as encapsulated tablets.
Other Name: Celexa

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473381

  Show 54 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473381     History of Changes
Other Study ID Numbers: VLZ-MD-01
Study First Received: November 14, 2011
Results First Received: June 13, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on October 19, 2014