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Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Vilazodone (Drug); Placebo (Drug); Fluoxetine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Michelle Aguirre, Study Director, Affiliation: Forest Research Institute, a subsidiary of Actavis plc.

Overall contact:
Anadil Shaikh, Phone: 866-369-5227, Ext: 8977, Email: Anadil.Shaikh@actavis.com

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.

Clinical Details

Official title: A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

Secondary outcome: Change in Clinical Global Impressions-Severity (CGI-S) Score

Eligibility

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or Female outpatients between 7-17 years of age

- Primary diagnosis of Major Depressive Disorder (MDD)

- Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

- Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

- Current (past 3 months) principal Diagnostic and Statistical Manual of Mental

Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.

- History of suicidal behavior, or requires precaution against suicide

- Not generally healthy medical condition

- Seizure disorder

Locations and Contacts

Anadil Shaikh, Phone: 866-369-5227, Ext: 8977, Email: Anadil.Shaikh@actavis.com

Forest Investigative Site 050, Birmingham, Alabama 35213, United States; Recruiting

Forest Investigative Site 009, Dothan, Alabama 36303, United States; Recruiting

Forest Investigative Site 041, Phoenix, Arizona 85016, United States; Not yet recruiting

Forest Investigative Site 013, Little Rock, Arkansas 72211, United States; Recruiting

Forest Investigative Site 101, Kelowna, British Columbia V1Y 1Z9, Canada; Not yet recruiting

Forest Investigative Site 049, Bellflower, California 90706, United States; Recruiting

Forest Investigative Site 053, Costa Mesa, California 92626, United States; Recruiting

Forest Investigative Site 036, Glendale, California 91206, United States; Recruiting

Forest Investigative Site 032, Orange, California 92868, United States; Terminated

Forest Investigative Site 004, San Diego, California 92108, United States; Recruiting

Forest Investigative Site 037, Washington, District of Columbia 20010, United States; Not yet recruiting

Forest Investigative Site 048, Hialeah, Florida 33012, United States; Recruiting

Forest Investigative Site 051, Homestead, Florida 33030, United States; Recruiting

Forest Investigative Site 010, Jacksonville, Florida 32256, United States; Recruiting

Forest Investigative Site 039, Kissimmee, Florida 34741, United States; Recruiting

Forest Investigative Site 056, Lauderhill, Florida 33319, United States; Recruiting

Forest Investigative Site 003, Orlando, Florida 32801, United States; Recruiting

Forest Investigative Site 054, Alpharetta, Georgia 30005, United States; Recruiting

Forest Investigative Site 022, Atlanta, Georgia 30331, United States; Recruiting

Forest Investigative Site 015, Marietta, Georgia 30060, United States; Recruiting

Forest Investigative Site 018, Libertyville, Illinois 60048, United States; Recruiting

Forest Investigative Site 005, Naperville, Illinois 60563, United States; Recruiting

Forest Investigative Site 044, Oak Park, Illinois 60301, United States; Recruiting

Forest Investigative Site 057, Indianapolis, Indiana 46260, United States; Recruiting

Forest Investigative Site 024, Terre Haute, Indiana 47802, United States; Recruiting

Forest Investigative Site 007, Overland Park, Kansas 66211, United States; Recruiting

Forest Investigative Site 052, Lake Charles, Louisiana 70629, United States; Recruiting

Forest Investigative Site 030, Baltimore, Maryland 21208, United States; Recruiting

Forest Investigative Site 033, Baltimore, Maryland 21205, United States; Recruiting

Forest Investigative Site 011, Rockville, Maryland 20852, United States; Recruiting

Forest Investigative Site 035, Springfield, Massachusetts 01199, United States; Not yet recruiting

Forest Investigative Site 008, Watertown, Massachusetts 02472, United States; Recruiting

Forest Investigative Site 016, Creve Coeur, Missouri 63141, United States; Recruiting

Forest Investigative Site 040, St. Charles, Missouri 63304, United States; Recruiting

Forest Investigative Site 029, Mt Kisco, New York 10549, United States; Recruiting

Forest Investigative Site 061, New York, New York 10022, United States; Recruiting

Forest Investigative Site 020, Rochester, New York 14618, United States; Recruiting

Forest Investigative Site 046, Staten Island, New York 10312, United States; Recruiting

Forest Investigative Site 025, Avon Lake, Ohio 44012, United States; Recruiting

Forest Investigative Site 047, Canton, Ohio 44718, United States; Recruiting

Forest Investigative Site 028, Cincinnati, Ohio 45219, United States; Recruiting

Forest Investigative Site 002, Columbus, Ohio 43210, United States; Recruiting

Forest Investigative Site 043, Mason, Ohio 45040, United States; Recruiting

Forest Investigative Site 031, Oklahoma City, Oklahoma 73103, United States; Recruiting

Forest Investigative Site 059, Oklahoma City, Oklahoma 73116, United States; Recruiting

Forest Investigative Site 102, Toronto, Ontario M5B 1T8, Canada; Not yet recruiting

Forest Investigative Site 103, Toronto, Ontario M4W2N4, Canada; Not yet recruiting

Forest Investigative Site 021, Memphis, Tennessee 38119, United States; Recruiting

Forest Investigative Site 006, Austin, Texas 78759, United States; Recruiting

Forest Investigative Site 045, Austin, Texas 78731, United States; Not yet recruiting

Forest Investigative Site 034, Dallas, Texas 75235, United States; Not yet recruiting

Forest Investigative Site 038, Houston, Texas 77007, United States; Recruiting

Forest Investigative Site 042, Houston, Texas 77079, United States; Recruiting

Forest Investigative Site 012, Plano, Texas 75234, United States; Recruiting

Forest Investigative Site 014, San Antonio, Texas 78229, United States; Recruiting

Forest Investigative Site 027, The Woodlands, Texas 77381, United States; Recruiting

Forest Investigative Site 017, Clinton, Utah 84015, United States; Recruiting

Forest Investigative Site 055, Charlottesville, Virginia 22903, United States; Recruiting

Forest Investigative Site 001, Bellevue, Washington 98007, United States; Recruiting

Forest Investigative Site 023, Kirkland, Washington 98033, United States; Recruiting

Additional Information

Starting date: February 2015
Last updated: July 9, 2015

Page last updated: August 23, 2015

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