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

Condition(s) targeted: Major Depressive Disorder

Intervention: DVS SR (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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).

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline to final on-therapy visit in the Children's Depression Rating Scale, Revised (CDRS-R) total score

Secondary outcome:

Clinical Global Impression - Improvement (CGI-I) score at the final on-therapy visit

Clinical Global Impression - Severity (CGI-S) score change from baseline at the final on-therapy visit

Clinical Global Impression - Improvement (CGI-I) response (score of 1 or 2)

Remission on the Children's Depression Rating Scale, Revised (CDRS-R) (score <=28)

Minimum age: 7 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Subject requires precaution against suicide

- Subject not in a generally healthy condition

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Harmonex, Dothan, Alabama 36303, United States; Recruiting

Dothan Behavioral Medicine Clinic, Dothan, Alabama 36303, United States; Recruiting

Dedicated Clinical Research, Phoenix, Arizona 85020, United States; Recruiting

University of Arizona College of Medicine Department of Psychiatry, Tucson, Arizona 85724, United States; Recruiting

University of Arizona Clinical and Translational Science Center (CATS), Tucson, Arizona 85724, United States; Recruiting

Arkansas Psychiatric Clinic Clinical Research Trials, P.A., Little Rock, Arkansas 72223, United States; Recruiting

ATP Clinical Research, Incorporated, Costa Mesa, California 92626, United States; Recruiting

Behavioral Research Specialists, LLC, Glendale, California 91206, United States; Recruiting

Synergy Clinical Research Center, National City, California 91950, United States; Recruiting

Pacific Clinical Research Medical Group, Orange, California 92868, United States; Recruiting

Sharp Mesa Vista Hospital, San Diego, California 92123, United States; Not yet recruiting

Neuropsychiatric Research Center of Orange County, Santa Ana, California 92701, United States; Recruiting

Elite Clinical Trials, Incorporated, Wildomar, California 92595, United States; Recruiting

Children's Hospital Colorado, Aurora, Colorado 80045, United States; Recruiting

Amedica Research Institute, Incorporated, Hialeah, Florida 33013, United States; Recruiting

Clinical Neuroscience Solutions Incorporated, Orlando, Florida 32806, United States; Recruiting

Kolin Research Group, Winter Park, Florida 32789, United States; Recruiting

Winter Park Memorial Hospital, Winterpark, Florida 32792, United States; Recruiting

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States; Recruiting

Institute for Behavioral Medicine, LLC, Smyrna, Georgia 30080-6315, United States; Recruiting

Hospital Aranda de la Parra, Leon, Guanajuato 37000, Mexico; Not yet recruiting

Psychiatric Associates, Overland Park, Kansas 66211, United States; Recruiting

Lake Charles Clinical Trials, Lake Charles, Louisiana 70629, United States; Recruiting

Louisiana Clinical Research, LLC, Shreveport, Louisiana 71115, United States; Not yet recruiting

Neuroscientific Insights, Rockville, Maryland 20852, United States; Not yet recruiting

Precise Research Centers, Flowood, Mississippi 39232, United States; Not yet recruiting

St. Charles Psychiatric Associates - Midwest Research Group, St. Charles, Missouri 63301, United States; Recruiting

Heartland Pharma Development, North Platte, Nebraska 69101, United States; Not yet recruiting

Creighton University, Department of Psychiatry, Omaha, Nebraska 68131, United States; Not yet recruiting

Center for Psychiatry and Behavioral Medicine, Incorporated, Las Vegas, Nevada 89128, United States; Recruiting

Bartky HealthCare Center, LLC, Summit, New Jersey 07901, United States; Not yet recruiting

Pulmonary and Allergy Associates, P.A., Summit, New Jersey 07901, United States; Not yet recruiting

PMG Research of Wilmington, Wilmington, North Carolina 28401, United States; Not yet recruiting

Essentia health, Fargo, North Dakota 58103, United States; Not yet recruiting

Odyssey Research, Fargo, North Dakota 58104, United States; Not yet recruiting

Prairie St. John's, Fargo, North Dakota 58103, United States; Not yet recruiting

Centro de Investigacion y Terapia, Monterrey, Nuevo Leon 64020, Mexico; Not yet recruiting

IPS Research Company, Oklahoma City, Oklahoma 73103, United States; Recruiting

Cutting Edge Research Group, Oklahoma City, Oklahoma 73116, United States; Recruiting

Summit Research Network (Oregon), Incorporated, Portland, Oregon 97210, United States; Recruiting

Clinical Neuroscience Solutions, Incorporated, Memphis, Tennessee 38119, United States; Recruiting

Grayline Clinical Drug Trials, Wichita Falls, Texas 76309, United States; Recruiting

Summit Research Network (Seattle) LLC, Seattle, Washington 98104, United States; Recruiting

Rogers Center for Research and Training, Incorporated, Milwaukee, Wisconsin 53227, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2012
Last updated: January 29, 2013