Major Depressive DisorderPhase 3VLZ-MD-22NCT02372799

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

A Phase 3 study testing Vilazodone and Fluoxetine in people with Major Depressive Disorder, run by Forest Laboratories at 60 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vilazodone and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 473 participants
Where: 60 sitesin 2 countries
Study dates: 28 Feb 2015to 11 Sep 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

60 sites in 2 countries.

Country

City, postcode or hospital

60 sites in 2 countries

United States58 sites

Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Atlantic Center for Medical Research
Atlanta, Georgia, 30331
FutureSearch Clinical trials, Inc.
Austin, Texas, 78731
BioBehavioral Research of Austin, PC
Austin, Texas, 78759
Haidar Almhana Nieding LLC
Avon Lake, Ohio, 44012
Hugo W Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, 21205
Pharmsite Research Inc.
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
CITrials - Bellflower
Bellflower, California, 90706
Alliance Clinical Research
Birmingham, Alabama, 35213
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718
UVA Center for Psychopharmacology Research in Youth
Charlottesville, Virginia, 22903
University of Cincinnati
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center, Psychiatry
Cleveland, Ohio, 44106
Ericksen Research and Development
Clinton, Utah, 84015
Ohio State Univ. Dept of Psychiatry
Columbus, Ohio, 43210
ATP Clinical Research
Costa Mesa, California, 92626
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141
University of TX Southwestern Medical Ctr
Dallas, Texas, 75235
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Core Clinical Research
Everett, Washington, 98033
Behavioral Research Specialists, LLC
Glendale, California, 91206
Hartford Hospital
Hartford, Connecticut, 06106
Palm Springs Research, LLC
Hialeah, Florida, 33012
IMIC Inc.
Homestead, Florida, 33030
Bayou City Research Ltd
Houston, Texas, 77007
Houston Endoscopy and Research Ctr
Houston, Texas, 77079
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Osceola Mental Health dba Park Place Behavioral Health Care
Kissimmee, Florida, 34741
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Capstone Clinical Research
Libertyville, Illinois, 60048
Woodland International Research Group, INC
Little Rock, Arkansas, 72211
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Professional Psychiatric Services
Mason, Ohio, 45040
Research Strategies of Memphis LLC
Memphis, Tennessee, 38119
BioScience Research LLC
Mount Kisco, New York, 10549
Baber Research Group
Naperville, Illinois, 60563
Manhattan Behavioral Medicine
New York, New York, 10022
Neuroscience Research Institute Inc.
Oak Park, Illinois, 60301
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Associates
Overland Park, Kansas, 66211
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Research Across America
Plano, Texas, 75234
Finger Lakes Clinical research
Rochester, New York, 14618
NeuroScientific Insights
Rockville, Maryland, 20852
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Focus and Balance
San Antonio, Texas, 78229
PCSD - Feighner Research
San Diego, California, 92108
Baystate Medical Center
Springfield, Massachusetts, 01199
Richmond Behavioral Associates
Staten Island, New York, 10312
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
Pacific Clinical Research Medical Group
Upland, California, 91786
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472

Other trials in United States

Canada2 sites

Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9
Paediatric Sleep Research Inc
Toronto, Ontario, M5B 1T8

Other trials in Canada

About this study

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

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.

Conditions: Major Depressive Disorder
Being tested: Vilazodone, Placebo, Fluoxetine
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VilazodoneDrug
Also called Viibryd
PlaceboDrug
FluoxetineDrug
Also called Prozac

Study groups in NCT02372799
Study group	Role	What they receive
Vilazodone	Experimental	Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day. Receives: Drug: Vilazodone
Placebo	Placebo comparator	Dose-matched placebo tablets or capsules, oral administration, once per day. Receives: Drug: Placebo
Fluoxetine	Active comparator	Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day. Receives: Drug: Fluoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Measured: From Baseline to Week 8

Secondary outcomes (1)

Change in Clinical Global Impressions-Severity (CGI-S) Score
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Measured: From Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201511 Sep 2018

First posted26 Feb 2015 (estimated)
Study start28 Feb 2015
Primary completion11 Sep 2018
Study completion11 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02372799
Sponsor's protocol ID: VLZ-MD-22
Acronym: VLZ-MD-22
Status last verified: Sep 2019
First submitted: 21 Feb 2015
Last updated: 1 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02372799
Acronym / sponsor ID: VLZ-MD-22 / VLZ-MD-22
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 28 Feb 2015 (actual)
Primary completion: 11 Sep 2018 (actual)
Study completion: 11 Sep 2018 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 1 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vilazodone	Experimental	Drug: VilazodoneVilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Placebo	Placebo comparator	Drug: PlaceboDose-matched placebo tablets or capsules, oral administration, once per day.
Fluoxetine	Active comparator	Drug: FluoxetineFluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VilazodoneAlso: Viibryd	Drug	Vilazodone
Placebo	Drug	Placebo
FluoxetineAlso: Prozac	Drug	Fluoxetine

Primary outcome

Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Time frame: From Baseline to Week 8
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

1 secondary outcome

Change in Clinical Global Impressions-Severity (CGI-S) Score
Time frame: From Baseline to Week 8

Results and safety

Results posted to the registry on 1 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	186	152
Vilazodone	187	155
Fluoxetine	97	82

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

Time frame: From Baseline to Week 8. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 182	Vilazodone n = 186	Fluoxetine n = 97
Value	-20.32 (0.983)	-20.72 (0.977)	-22.71 (1.320)

Placebo vs Vilazodone: LSMD: -0.40 (95% CI -3.08 to 2.27), p = 0.7662, MMRM
Placebo vs Fluoxetine: LSMD: -2.39 (95% CI -5.60 to 0.81), p = 0.1433, MMRM

Population analysed: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 186 (0.5%)	54 of 186 (29%)	0 of 186
Vilazodone	0 of 187 (0%)	97 of 187 (51.9%)	0 of 187
Fluoxetine	6 of 97 (6.2%)	27 of 97 (27.8%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily McCusker, PhD study director

Forest Research Institute, an affiliate of Allergan plc.

60 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vilazodone and Fluoxetine in people with Major Depressive Disorder, run by Forest Laboratories at 60 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score (time frame: From Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02372799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.