Major Depressive DisorderPhase 3NCT01372150
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
A Phase 3 study testing desvenlafaxine succinate sustained release and fluoxetine in people with Major Depressive Disorder, run by Pfizer at 43 sites in 2 countries.
Trial summary
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs 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 and fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 43 sitesin 2 countries
- Study dates
- 17 Nov 2011to 20 Mar 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 behaviour, or requires precaution against suicide
- Not in generally healthy medical condition
- History of psychosis or bipolar disorder
- Seizure disorder
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States41 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Children's Hospital Colorado
Aurora, Colorado, 80045
Northwest Clinical Research Center
Bellevue, Washington, 98007
Cincinnati Children's Hospital Medical Center (New)
Cincinnati, Ohio, 45229
ATP Clinical Research, Inc. 1
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
Nina F. Wimpie, MD Pediatrics
Middleburg Heights, Ohio, 44130
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Rogers Center For Research And Training
Milwaukee, Wisconsin, 53227
Synergy Clinical Research Center
National City, California, 91950
Heartland Pharma Developments
North Platte, Nebraska, 69101
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118
Creighton University
Omaha, Nebraska, 68131
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
Neuroscientific Insights
Rockville, Maryland, 20852
Midwest Research Group
Saint Charles, Missouri, 63304
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Focus & Balance, LLC
San Antonio, Texas, 78229
Sharp Mesa Vista Hospital
San Diego, California, 92123
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
Institute for Behavioral Medicine
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
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Elite Clinical Trials, Incorporated
Wildomar, California, 92595
Kolin Research Group
Winter Park, Florida, 32789-3747
Winter Park Memorial Hospital
Winter Park, Florida, 32792
Mexico2 sites
Hospital Aranda de la Parra S.A. de C.V.
León, Guanajuato, 37000
CIT - Neuropsique, S.C.
Monterrey, Nuevo León, 64610
About this study
Official title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, 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
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
- Conditions
- Major Depressive Disorder
- Being tested
- desvenlafaxine succinate sustained release, fluoxetine, 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 group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
fluoxetineDrug
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
placeboDrug
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
| Study group | Role | What they receive |
|---|---|---|
| DVS SR | Experimental | Not described Receives: Drug: desvenlafaxine succinate sustained release |
| Fluoxetine | Other | Active control for assay sensitivity Receives: Drug: fluoxetine |
| Placebo | Experimental | 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
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: Baseline and Week 8
Secondary outcomes (3)
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
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: 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 = more affected.
Measured: Baseline and 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), 2 (much improved), or 3 (minimally 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.
- First posted13 Jun 2011 (estimated)
- Study start17 Nov 2011
- Primary completion20 Mar 2015
- Study completion20 Mar 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.
- 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
- 340 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
- NCT01372150
- Sponsor's protocol ID
- B2061014
- Other IDs
- 3151A6-3356, 2008-002063-13, 2008
- Status last verified
- Jan 2019
- First submitted
- 9 Jun 2011
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, 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
- NCT01372150
- Acronym / sponsor ID
- B2061014
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2011 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 20 Nov 2015
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 Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
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 |
|---|---|---|
| DVS SR | Experimental | Drug: desvenlafaxine succinate sustained release |
| Fluoxetine | Other | Drug: fluoxetineActive control for assay sensitivity |
| Placebo | Experimental | 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 behaviour, 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 group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets. | Drug | DVS SR |
| fluoxetineSubjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules | Drug | Fluoxetine |
| placeboSubjects randomized to the placebo group receive corresponding placebo tablets and/capsules | Drug | Placebo |
Primary outcome
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
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. Adjusted mean presented.
3 secondary outcomes
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
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: Baseline and 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
43 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 desvenlafaxine succinate sustained release and fluoxetine in people with Major Depressive Disorder, run by Pfizer at 43 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 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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 20 Nov 2015). 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 (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?
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 15 Jan 2019.