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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of two fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.


Condition Intervention Phase
Major Depressive Disorder
 Drug: Placebo
Drug: 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • MÅDRS Sustained Remission [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1120
Study Start Date: November 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo capsules, oral administration
 Drug: Placebo
Dose-matched placebo. Oral administration, once per day.
Experimental: Vilazodone 20mg
20 mg/day vilazodone tablets, oral administration
 Drug: Vilazodone
Vilazodone 20 mg. Oral administration, once per day.
Other Name: Viibryd
Experimental: Vilazodone 40mg
40 mg/day vilazodone tablets, oral administration
 Drug: Vilazodone
Vilazodone 40 mg. Oral administration, once per day.
Other Name: Viibryd
Active Comparator: Citalopram
Citalopram, 40 mg/day, oral administration, once daily
 Drug: Citalopram
Citalopram 40 mg. Oral administration, once per day.
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
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
Last Updated: April 15, 2013
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
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 21, 2013