MedDataX Logo

Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

NCT ID: NCT01878292

Last Updated: 2019-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-11

Study Completion Date

2016-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Dose-matched placebo tablets, once per day, oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose matched placebo tablets, once per day, oral administration.

Vilazodone 15 mg

15 mg vilazodone tablets, once per day, oral administration

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Vilazodone tablets, 15 mg per day, oral administration

vilazodone 30 mg

30 mg vilazodone tablets, once per day, oral administration

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Vilazodone tablets, 30 mg once per day, oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Dose matched placebo tablets, once per day, oral administration.

Intervention Type DRUG

Vilazodone

Vilazodone tablets, 15 mg per day, oral administration

Intervention Type DRUG

Vilazodone

Vilazodone tablets, 30 mg once per day, oral administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Viibryd Viibryd

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or Female outpatients between 12-17 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chandran Prakash

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forest Investigative Site 073

Imperial, California, United States

Site Status

Forest Investigative Site 052

Los Angeles, California, United States

Site Status

Forest Investigative Site 023

Murrieta, California, United States

Site Status

Forest Investigative Site 004

Orange, California, United States

Site Status

Forest Investigative Site 037

San Diego, California, United States

Site Status

Forest Investigative Site 006

Washington D.C., District of Columbia, United States

Site Status

Forest Investigative Site 039

Gainesville, Florida, United States

Site Status

Forest Investigative Site 009

Jacksonville Beach, Florida, United States

Site Status

Forest Investigative Site 063

Miami, Florida, United States

Site Status

Forest Investigative Site 034

Oakland Park, Florida, United States

Site Status

Forest Investigative Site 016

Orlando, Florida, United States

Site Status

Forest Investigative Site 064

Orlando, Florida, United States

Site Status

Forest Investigative Site 014

Atlanta, Georgia, United States

Site Status

Forest Investigative Site 030

Roswell, Georgia, United States

Site Status

Forest Investigative Site 032

Libertyville, Illinois, United States

Site Status

Forest Investigative Site 048

Naperville, Illinois, United States

Site Status

Forest Investigative Site 051

Terre Haute, Indiana, United States

Site Status

Forest Investigative Site 013

Overland Park, Kansas, United States

Site Status

Forest Investigative Site 070

Lake Charles, Louisiana, United States

Site Status

Forest Investigative Site 050

Baltimore, Maryland, United States

Site Status

Forest Investigative Site 054

Baltimore, Maryland, United States

Site Status

Forest Investigative Site 049

Rockville, Maryland, United States

Site Status

Forest Investigative Site 026

Watertown, Massachusetts, United States

Site Status

Forest Investigative Site 024

Rochester Hills, Michigan, United States

Site Status

Forest Investigative Site 015

Creve Coeur, Missouri, United States

Site Status

Forest Investigative Site 055

Saint Charles, Missouri, United States

Site Status

Forest Investigative Site 072

St Louis, Missouri, United States

Site Status

Forest Investigative Site 066

Las Vegas, Nevada, United States

Site Status

Forest Investigative Site 007

Cherry Hill, New Jersey, United States

Site Status

Forest Investigative Site 071

Neptune City, New Jersey, United States

Site Status

Forest Investigative Site 008

Albuquerque, New Mexico, United States

Site Status

Forest Investigative Site 057

Rochester, New York, United States

Site Status

Forest Investigative Site 059

Durham, North Carolina, United States

Site Status

Forest Investigative Site 053

Avon Lake, Ohio, United States

Site Status

Forest Investigative Site 021

Canton, Ohio, United States

Site Status

Forest Investigative Site 012

Cincinnati, Ohio, United States

Site Status

Forest Investigative Site 029

Columbus, Ohio, United States

Site Status

Forest Investigative Site 018

Oklahoma City, Oklahoma, United States

Site Status

Forest Investigative Site 011

Oklahoma City, Oklahoma, United States

Site Status

Forest Investigative Site 065

Tulsa, Oklahoma, United States

Site Status

Forest Investigative Site 040

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site 074

Charleston, South Carolina, United States

Site Status

Forest Investigative Site 062

Memphis, Tennessee, United States

Site Status

Forest Investigative Site 001

Dallas, Texas, United States

Site Status

Forest Investigative Site 027

Houston, Texas, United States

Site Status

Forest Investigative Site 041

Plano, Texas, United States

Site Status

Forest Investigative Site 045

The Woodlands, Texas, United States

Site Status

Forest Investigative Site 019

Clinton, Utah, United States

Site Status

Forest Investigative Site 060

Richmond, Virginia, United States

Site Status

Forest Investigative Site 035

Bellevue, Washington, United States

Site Status

Forest Investigative Site 068

Bothell, Washington, United States

Site Status

Forest Investigative Site 022

Kirkland, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Durgam S, Chen C, Migliore R, Prakash C, Edwards J, Findling RL. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder. Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4.

Reference Type DERIVED
PMID: 29633166 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VLZ-MD-21

Identifier Type: -

Identifier Source: org_study_id