Major Depressive DisorderPhase 3VLZ-MD-21NCT01878292

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

A Phase 3 study testing Vilazodone in people with Major Depressive Disorder, run by Forest Laboratories at 52 sites in United States.

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 relative to placebo in adolescent outpatients (12-17) with major depressive disorder. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vilazodone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 529 participants
Where: 52 sitesUnited States
Study dates: 11 Jul 2013to 5 Oct 2016
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

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

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

Forest Investigative Site 008
Albuquerque, New Mexico, 87109
Forest Investigative Site 014
Atlanta, Georgia, 30308
Forest Investigative Site 053
Avon Lake, Ohio, 44012
Forest Investigative Site 050
Baltimore, Maryland, 21205
Forest Investigative Site 054
Baltimore, Maryland, 21208
Forest Investigative Site 035
Bellevue, Washington, 98007
Forest Investigative Site 068
Bothell, Washington, 98011
Forest Investigative Site 021
Canton, Ohio, 44718
Forest Investigative Site 074
Charleston, South Carolina, 29407
Forest Investigative Site 007
Cherry Hill, New Jersey, 08002
Forest Investigative Site 012
Cincinnati, Ohio, 45219
Forest Investigative Site 019
Clinton, Utah, 84015
Forest Investigative Site 029
Columbus, Ohio, 43210
Forest Investigative Site 015
Creve Coeur, Missouri, 63141
Forest Investigative Site 001
Dallas, Texas, 75235
Forest Investigative Site 059
Durham, North Carolina, 27705
Forest Investigative Site 039
Gainesville, Florida, 32607
Forest Investigative Site 027
Houston, Texas, 77098
Forest Investigative Site 073
Imperial, California, 92251
Forest Investigative Site 009
Jacksonville Beach, Florida, 32250
Forest Investigative Site 022
Kirkland, Washington, 98033
Forest Investigative Site 070
Lake Charles, Louisiana, 70629
Forest Investigative Site 066
Las Vegas, Nevada, 89128
Forest Investigative Site 032
Libertyville, Illinois, 60048
Forest Investigative Site 052
Los Angeles, California, 90027
Forest Investigative Site 062
Memphis, Tennessee, 38119
Forest Investigative Site 063
Miami, Florida, 33155
Forest Investigative Site 023
Murrieta, California, 92562
Forest Investigative Site 048
Naperville, Illinois, 60563
Forest Investigative Site 071
Neptune City, New Jersey, 07752
Forest Investigative Site 034
Oakland Park, Florida, 33334
Forest Investigative Site 018
Oklahoma City, Oklahoma, 73103
Forest Investigative Site 011
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 004
Orange, California, 92868
Forest Investigative Site 016
Orlando, Florida, 32803
Forest Investigative Site 064
Orlando, Florida, 32806
Forest Investigative Site 013
Overland Park, Kansas, 66211
Forest Investigative Site 040
Philadelphia, Pennsylvania, 19139
Forest Investigative Site 041
Plano, Texas, 75093
Forest Investigative Site 060
Richmond, Virginia, 23230
Forest Investigative Site 057
Rochester, New York, 14618
Forest Investigative Site 024
Rochester Hills, Michigan, 48307
Forest Investigative Site 049
Rockville, Maryland, 20852
Forest Investigative Site 030
Roswell, Georgia, 30076
Forest Investigative Site 055
Saint Charles, Missouri, 63304
Forest Investigative Site 037
San Diego, California, 92108
Forest Investigative Site 072
St Louis, Missouri, 63128
Forest Investigative Site 051
Terre Haute, Indiana, 47802
Forest Investigative Site 045
The Woodlands, Texas, 77381
Forest Investigative Site 065
Tulsa, Oklahoma, 74104
Forest Investigative Site 006
Washington D.C., District of Columbia, 20010
Forest Investigative Site 026
Watertown, Massachusetts, 02472

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About this study

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

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.

Conditions: Major Depressive Disorder
Being tested: Placebo, Vilazodone
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.

PlaceboDrug
Dose matched placebo tablets, once per day, oral administration.
VilazodoneDrug
Also called Viibryd
Vilazodone tablets, 15 mg per day, oral administration
VilazodoneDrug
Also called Viibryd
Vilazodone tablets, 30 mg once per day, oral administration

Study groups in NCT01878292
Study group	Role	What they receive
Placebo	Placebo comparator	Dose-matched placebo tablets, once per day, oral administration Receives: Drug: Placebo
Vilazodone 15 mg	Experimental	15 mg vilazodone tablets, once per day, oral administration Receives: Drug: Vilazodone
vilazodone 30 mg	Experimental	30 mg vilazodone tablets, once per day, oral administration Receives: Drug: Vilazodone

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.

11 Jul 20135 Oct 2016

First posted14 Jun 2013 (estimated)
Study start11 Jul 2013
Primary completion17 Mar 2016
Study completion5 Oct 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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: 529 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878292
Sponsor's protocol ID: VLZ-MD-21
Acronym: VLZ-MD-21
Status last verified: Dec 2019
First submitted: 11 Jun 2013
Last updated: 24 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29633166

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01878292
Acronym / sponsor ID: VLZ-MD-21 / VLZ-MD-21
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 529 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 11 Jul 2013 (actual)
Primary completion: 17 Mar 2016 (actual)
Study completion: 5 Oct 2016 (actual)
First posted: 14 Jun 2013 (estimated)
Results: Posted 24 Dec 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 relative to placebo in adolescent outpatients (12-17) 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
Placebo	Placebo comparator	Drug: PlaceboDose-matched placebo tablets, once per day, oral administration
Vilazodone 15 mg	Experimental	Drug: Vilazodone15 mg vilazodone tablets, once per day, oral administration
vilazodone 30 mg	Experimental	Drug: Vilazodone30 mg vilazodone tablets, once per day, oral administration

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

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
PlaceboDose matched placebo tablets, once per day, oral administration.	Drug	Placebo
VilazodoneAlso: ViibrydVilazodone tablets, 15 mg per day, oral administration	Drug	Vilazodone 15 mg
VilazodoneAlso: ViibrydVilazodone tablets, 30 mg once per day, oral administration	Drug	vilazodone 30 mg

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 24 Dec 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	174	171
Vilazodone 15 mg	175	175
Vilazodone 30 mg	180	180

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 = 170	Vilazodone 15 mg n = 174	Vilazodone 30 mg n = 180
Value	-22.48 (0.921)	-22.94 (0.904)	-24.22 (0.872)

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 for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 171 (0.6%)	63 of 171 (36.8%)	0 of 171
Vilazodone 15 mg	2 of 175 (1.1%)	81 of 175 (46.3%)	0 of 175
Vilazodone 30 mg	3 of 180 (1.7%)	97 of 180 (53.9%)	0 of 180

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29633166Durgam 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.

Related trials for Major Depressive Disorder

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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
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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.

Chandran Prakash study director

Allergan

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vilazodone in people with Major Depressive Disorder, run by Forest Laboratories at 52 sites in United States.

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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. 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 24 Dec 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 NCT01878292, which also lists 1 linked publication.

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 24 Dec 2019.