A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: desvenlafaxine succinate sustained release Drug: fluoxetine Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fluoxetine-Referenced, Parallel-Group Study To Evaluate The Safety, Efficacy, And Tolerability Of DVS SR In Children And Adolescent Outpatients With Major Depressive Disorder |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Fluoxetine
Fluoxetine hydrochloride
Desvenlafaxine
Desvenlafaxine Succinate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline to final on-therapy visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impression Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- CGI-S score change from baseline at the final on-therapy visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- CGI-I response (1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DVS SR |
Drug: desvenlafaxine succinate sustained release
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.
|
|
Fluoxetine
Active control for assay sensitivity
|
Drug: fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
|
| Experimental: Placebo |
Drug: placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
|
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >=7 and <18 years of age
- Primary diagnosis of major depressive disorder (MDD)
- CDRS-R score >40
Exclusion Criteria:
- History of suicidal behaviour, or requires precaution against suicide
- Not in generally healthy medical condition
- History of psychosis or bipolar disorder
- Seizure disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372150
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Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, Alabama | |
| Harmonex | Recruiting |
| Dothan, Alabama, United States, 36303 | |
| Dothan Behavioral Medicine Clinic | Recruiting |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Dedicated Clinical Research | Recruiting |
| Phoenix, Arizona, United States, 85020 | |
| University of Arizona Clinical and Translational Science Center | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| University of Arizona College of Medicine Department of Psychiatry | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Arkansas Psychiatric Clinic Clinical Research Trials, P.A. | Recruiting |
| Little Rock, Arkansas, United States, 72223 | |
| United States, California | |
| ATP Clinical Research, Incorporated | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Behavioral Research Specialists, LLC | Recruiting |
| Glendale, California, United States, 91206 | |
| Synergy Clinical Research Center | Recruiting |
| National City, California, United States, 91950 | |
| Pacific Clinical Research Medical Group | Recruiting |
| Orange, California, United States, 92868 | |
| Sharp Mesa Vista Hospital | Not yet recruiting |
| San Diego, California, United States, 92123 | |
| Neuropsychiatric Research Center of Orange County | Recruiting |
| Santa Ana, California, United States, 92701 | |
| Elite Clinical Trials, Incorporated | Recruiting |
| Wildomar, California, United States, 92595 | |
| United States, Colorado | |
| The Children's Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Amedica Research Institute, Incorporated | Recruiting |
| Hialeah, Florida, United States, 33013 | |
| Clinical Neuroscience Solutions Incorporated | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Kolin Research Group | Recruiting |
| Winter Park, Florida, United States, 32789-3747 | |
| Winter Park Memorial Hospital | Recruiting |
| Winter Park, Florida, United States, 32792 | |
| United States, Georgia | |
| Atlanta Center for Medical Research | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Institute for Behavioral Medicine, LLC | Recruiting |
| Smyrna, Georgia, United States, 30080-6315 | |
| United States, Kansas | |
| Psychiatric Associates | Recruiting |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| Lake Charles Clinical Trials | Recruiting |
| Lake Charles, Louisiana, United States, 70629 | |
| United States, Maryland | |
| Neuroscientific Insights | Recruiting |
| Rockville, Maryland, United States, 20852 | |
| United States, Mississippi | |
| Precise Research Centers | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| St. Charles Psychiatric Associates - Midwest Research Group | Recruiting |
| St. Charles, Missouri, United States, 63301 | |
| Midwest Chest Consultants | Recruiting |
| St. Charles, Missouri, United States, 63301 | |
| United States, Nebraska | |
| Heartland Pharma Development | Recruiting |
| North Platte, Nebraska, United States, 69101 | |
| Creighton University, Department of Psychiatry | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| Center for Psychiatry and Behavioral Medicine, Incorporated | Recruiting |
| Las Vegas, Nevada, United States, 89128 | |
| United States, North Carolina | |
| PMG Research of Wilmington | Not yet recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| United States, North Dakota | |
| Essentia Health | Not yet recruiting |
| Fargo, North Dakota, United States, 58103 | |
| Odyssey Research | Not yet recruiting |
| Fargo, North Dakota, United States, 58104 | |
| Prairie St. Johns | Not yet recruiting |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oklahoma | |
| Cutting Edge Research of Enid | Recruiting |
| Enid, Oklahoma, United States, 73703 | |
| IPS Research Company | Recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Cutting Edge Research of Enid | Recruiting |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Oregon | |
| Summit Research Network (Oregon), Incorporated | Recruiting |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Clinical Neuroscience Solutions, Incorporated | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Grayline Clinical Drug Trials | Recruiting |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Washington | |
| Summit Research Network (Seattle) LLC | Recruiting |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Rogers Center for Research and Training, Incorporated | Recruiting |
| Milwaukee, Wisconsin, United States, 53227 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01372150 History of Changes |
| Other Study ID Numbers: | B2061014, 3151A6-3356 |
| Study First Received: | June 9, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
major depressive disorder MDD depression |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Fluoxetine O-desmethylvenlafaxine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013