Major Depressive DisorderPhase 3NCT01371721
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
A Phase 3 study testing DVS SR in people with Major Depressive Disorder, run by Pfizer at 35 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
- 269 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Feb 2012to Oct 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
- Completed study B2061014 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
- Subject requires precaution against suicide
- Subject not in a generally healthy condition
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Children's Hospital Colorado
Aurora, Colorado, 80045
Northwest Clinical Research Center
Bellevue, Washington, 98007
ATP Clinical Research, Incorporated
Costa Mesa, California, 92626
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, 36303
Precise Research Centers
Flowood, Mississippi, 39232
Behavioral Research Specialists, LLC
Glendale, California, 91206
Dedicated Clinical Research
Goodyear, Arizona, 85395
Amedica Research Institute, Incorporated
Hialeah, Florida, 33013
Lake Charles Clinical Trials,
Lake Charles, Louisiana, 70629
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, 89128
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72211
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Rogers Center for Research and Training, Incorporated
Milwaukee, Wisconsin, 53227
Synergy Clinical Research Center
National City, California, 91950
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
Pacific Clinical Research Medical Group
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Associates
Overland Park, Kansas, 66211
Summit Research Network (Oregon), Incorporated
Portland, Oregon, 97210
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63303
Focus & Balance, LLC
San Antonio, Texas, 78229
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, 30080
University of Arizona Clinical and Translational Science Center (CATS)
Tucson, Arizona, 85724
University of Arizona College of Medicine Dept of Psychiatry
Tucson, Arizona, 85724
Elite Clinical Trials, Incorporated
Wildomar, California, 92595
Kolin Research Group
Winter Park, Florida, 32789-3747
Grayline Clinical Drug Trials
Witchita Falls, Texas, 76309
Mexico2 sites
Hospital Aranda de la Parra, S.A. de C.V.
León, Guanajuato, 37000
CIT-Neuropsique, S.C.
Monterrey, Nuevo León, 64010
About this study
Official title: A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 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 Experiencing a Treatment Emergent Adverse Event
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Secondary outcomes (5)
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
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. Adjusted mean presented.
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
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. Adjusted mean presented.
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
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. Adjusted mean presented.
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
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 = more affected.
Measured: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
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 startFeb 2012
- Primary completionOct 2015
- Study completionOct 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
- Masking
- None (open label)
- Enrolment
- 269 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
- NCT01371721
- Sponsor's protocol ID
- B2061031
- Other IDs
- 3151A6-3357, 2008-002064-34, 2008
- Status last verified
- Dec 2016
- First submitted
- 9 Jun 2011
- Last updated
- 8 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 8 Feb 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 B2061014 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
- NCT01371721
- Acronym / sponsor ID
- B2061031
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 8 Feb 2017
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
- 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 B2061014 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 (2 listed)
- Subject requires precaution against suicide
- Subject not in a generally healthy condition
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 Experiencing a Treatment Emergent Adverse Event
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
5 secondary outcomes
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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
35 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 35 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 2 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, 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. 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 Feb 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?
Percentage of Participants Experiencing a Treatment Emergent Adverse Event (time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study). 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 NCT01371721, 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 8 Feb 2017.