Major Depressive DisorderPhase 3NCT01371734

A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

A Phase 3 study testing Desvenlafaxine Succinate Sustained-Release in people with Major Depressive Disorder, run by Pfizer at 42 sites in 3 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

This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD). 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?: Desvenlafaxine Succinate Sustained-Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 42 sitesin 3 countries
Study dates: Aug 2011to Sep 2015
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

Age >=7 and <18 years of age
Primary diagnosis of major depressive disorder (MDD)
CDRS-R score >40

Who cannot join

History of suicidal behavior or requires precaution against suicide
Not in generally healthy medical condition
History of psychosis or bipolar disorder
Seizure disorder

Trial locations and contacts

42 sites in 3 countries.

Country

City, postcode or hospital

42 sites in 3 countries

United States39 sites

FutureSearch Trials
Austin, Texas, 78731
Pharmasite Research Inc
Baltimore, Maryland, 21208
Children's Hospital of Alabama Laboratory
Birmingham, Alabama, 35233
The University of Alabama at Birmingham, Office of Psychiatric Research
Birmingham, Alabama, 35294
Erie County Medical Center / State University of New York at Buffalo affiliate
Buffalo, New York, 14215
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Discovery and Wellness Center for Children/University Hospitals Case Medical Center
Cleveland, Ohio, 44106
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
SJS Clinical Research, Inc.
Destin, Florida, 32541
Sarkis Clinical Trials
Gainesville, Florida, 32607
The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
Glen Oaks, New York, 11004
Bliss Basement Pharmacy - Hartford Hospital
Hartford, Connecticut, 06102
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
Institute of Living
Hartford, Connecticut, 06106
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Capstone Clinical Research
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Research Strategies of Memphis, LLC.
Memphis, Tennessee, 38119
Bioscience Research, LLC.
Mount Kisco, New York, 10549
AMR-Baber Research Inc.
Naperville, Illinois, 60563
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Medical Research Group of Central Florida
Orange City, Florida, 32763
Millenia Psychiatry & Research, Inc.
Orlando, Florida, 32839
Alliance Research Group
Richmond, Virginia, 23230
Virginia Commonwealth University
Richmond, Virginia, 23298
Virginia Treatment Center
Richmond, Virginia, 23298
Carilion Medical Center
Roanoke, Virginia, 24014
Finger Lakes Clinical Research
Rochester, New York, 14618
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
Shreveport, Louisiana, 71103
Drug:University Health Shreveport Outpatient
Shreveport, Louisiana, 71130
Stony Brook University Medical Center, Child And Adolescent Psychiatry
Stony Brook, New York, 11794-8790
Clinco
Terre Haute, Indiana, 47802
Center for Advanced Improvement
Tucson, Arizona, 85719
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407

Other trials in United States

Chile2 sites

Biomedica Research Group
Santiago, Santiago Metropolitan, 7500710
Optima Salud
Santiago, Santiago Metropolitan, 8320325

Other trials in Chile

Mexico1 site

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
Monterrey, Nuevo León, 064460

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: Desvenlafaxine Succinate Sustained-Release, Placebo
Keywords: Major Depressive Disorder, MDD, Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

Desvenlafaxine Succinate Sustained-ReleaseDrug
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Desvenlafaxine Succinate Sustained-ReleaseDrug
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
PlaceboDrug
Subjects randomized to the Placebo treatment arm will receive placebo tablets

Study groups in NCT01371734
Study group	Role	What they receive
Experimental Arm 1 - high dose	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release
Experimental Arm 2 - low dose	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release
Placebo Arm	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.
Measured: Baseline and Week 8

Secondary outcomes (3)

Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender.
Measured: Baseline and Week 8
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score equals (=) more affected.
Measured: Weeks 1, 2, 3, 4, 6, and 8
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Higher score = more affected.
Measured: Weeks 1, 2, 3, 4, 6, and 8

Timeline

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

Aug 2011Sep 2015

First posted13 Jun 2011 (estimated)
Study startAug 2011
Primary completionSep 2015
Study completionSep 2015

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.
More trials run by PfizerThe sponsor's other registered studies.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01371734
Sponsor's protocol ID: B2061032
Other IDs: 3151A6-3343, 2008-001875-32, 2008
Status last verified: Jan 2017
First submitted: 9 Jun 2011
Last updated: 20 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.
PubMed 29185786

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 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01371734
Acronym / sponsor ID: B2061032
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, MDD, Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 13 Jun 2011 (estimated)
Results: Posted 20 Mar 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Experimental Arm 1 - high dose	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release
Experimental Arm 2 - low dose	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release
Placebo Arm	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

Age >=7 and <18 years of age
Primary diagnosis of major depressive disorder (MDD)
CDRS-R score >40

Key exclusion criteria (4 listed)

History of suicidal behavior or requires precaution against suicide
Not in generally healthy medical condition
History of psychosis or bipolar disorder
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
Desvenlafaxine Succinate Sustained-ReleaseSubjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.	Drug	Experimental Arm 1 - high dose
Desvenlafaxine Succinate Sustained-ReleaseSubjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.	Drug	Experimental Arm 2 - low dose
PlaceboSubjects randomized to the Placebo treatment arm will receive placebo tablets	Drug	Placebo Arm

Primary outcome

Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Time frame: Baseline and Week 8
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.

3 secondary outcomes

Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
Time frame: Baseline and Week 8
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Time frame: Weeks 1, 2, 3, 4, 6, and 8

Results and safety

Results posted to the registry on 20 Mar 2017, 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	120	97
DVS SR Low Dose	122	103
DVS SR High Dose	121	104

Primary outcome: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)

Time frame: Baseline and Week 8. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Placebo n = 119	DVS SR Low Dose n = 120	DVS SR High Dose n = 121
Value	-22.85 (1.13)	-23.70 (1.12)	-24.37 (1.12)

Placebo vs DVS SR Low Dose: Mean Difference (Net): 0.85 (95% CI -2.23 to 3.94), p = 0.587, Mixed-effects model for repeated measure
Placebo vs DVS SR High Dose: Mean Difference (Net): 1.52 (95% CI -1.56 to 4.61), p = 0.333, Mixed-effects model for repeated measure

Population analysed: Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment. n is the number of participants with evaluable data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 8 for participants entering the extension study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 120 (1.7%)	34 of 120 (28.3%)	Not reported
DVS SR Low Dose	2 of 122 (1.6%)	46 of 122 (37.7%)	Not reported
DVS SR High Dose	1 of 121 (0.8%)	53 of 121 (43.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29185786Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

42 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desvenlafaxine Succinate Sustained-Release in people with Major Depressive Disorder, run by Pfizer at 42 sites in 3 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 3 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Chile, Mexico. 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 20 Mar 2017). 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 From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) (time frame: Baseline and 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 NCT01371734, 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 20 Mar 2017.