Major Depressive DisorderPhase 3NCT01371708
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
A Phase 3 study testing DVS SR in people with Major Depressive Disorder, run by Pfizer at 36 sites in 2 countries.
Trial summary
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child 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?
- DVS SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 2 Feb 2012to 22 Apr 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR
- Willingness and ability to comply with scheduled visits, treatment plan, and procedures
Who cannot join
- Requires precaution against suicide
- Not in generally healthy medical condition
- Poor compliance with study drug or study procedures during participation in study B2061032
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
FutureSearch Trials
Austin, Texas, 78731
Pharmasite Research, Inc
Baltimore, Maryland, 21208
The University Of Alabama At Birmingham, Office Of Psychiatric Research
Birmingham, Alabama, 35294-0009
Erie County Medical Center/State University of New York (SUNY) 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
Institute of Living/Hartford Hospital
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
Baber Research Group
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
Allance Research Group
Richmond, Virginia, 23230
Alliance Research Group
Richmond, Virginia, 23230
Virginia Commonwealth University
Richmond, Virginia, 23298
Virginia Treatment Center for Children
Richmond, Virginia, 23298
Finger Lakes Clinical Research
Rochester, New York, 14618
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Clinical Trials of Texas, INC
San Antonio, Texas, 78229
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
About this study
Official title: A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).
- Conditions
- Major Depressive Disorder
- Being tested
- DVS SR
- 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.
DVS SRDrug
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine Succinate Sustained-Release | Experimental | Not described Receives: Drug: DVS SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Secondary outcomes (10)
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Measured: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study start2 Feb 2012
- Primary completion22 Apr 2016
- Study completion22 Apr 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371708
- Sponsor's protocol ID
- B2061030
- Other IDs
- 3151A6-3344, 2008-001876-67, 2008
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2011
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.
PubMed 30419989
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01371708
- Acronym / sponsor ID
- B2061030
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2012 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 8 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine Succinate Sustained-Release | Experimental | Drug: DVS SR |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR
- Willingness and ability to comply with scheduled visits, treatment plan, and procedures
Key exclusion criteria (3 listed)
- Requires precaution against suicide
- Not in generally healthy medical condition
- Poor compliance with study drug or study procedures during participation in study B2061032
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 |
|---|---|---|
| DVS SRSubjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator | Drug | Desvenlafaxine Succinate Sustained-Release |
Primary outcome
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
10 secondary outcomes
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30419989Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.
- 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
36 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 DVS SR in people with Major Depressive Disorder, run by Pfizer at 36 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 2 inclusion and 3 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Chile. 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. 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 8 Dec 2016). 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?
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030). The study lists 2 primary outcomes in all. 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 NCT01371708, 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 27 Jul 2017.