Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder

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NCT00669110

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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
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Contact
1-800-718-1021
[email protected]er.com
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term treatment.

- Study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Clinically important abnormalities on baseline physical examination or any clinically
significant abnormality on electrocardiogram (ECG), laboratory test results, or vital
signs recorded before the final study day (day 56 visit) of the preceding study
3151A6-2000.


- Unresolved clinically significant adverse events or serious adverse events in the
preceding study 3151A6-2000.


- Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator
and the medical monitor.


- Other exclusion criteria apply.

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Major Depressive Disorder Depressive DisorderStudy Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
NCT00669110
  1. Little Rock, Arkansas
  2. North Miami, Florida
  3. Terre Haute, Indiana
  4. Wichita, Kansas
  5. New Orleans, Louisiana
  6. New York, New York
  7. Cleveland, Ohio
  8. Hershey, Pennsylvania
  9. Houston, Texas
ALL GENDERS
7 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Official Title  ICMJE 6-Month, Multicenter, Open-Label, Flexible-Dose Study To Evaluate Safety, Efficacy, And Tolerability Of Desvenlafaxine Succinate Sustained-Release Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Brief Summary The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the treatment of child and adolescent outpatients with major depressive disorder in an exploratory manner.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major Depressive Disorder
Intervention  ICMJE Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
  • tablet
  • subjects randomly assigned to 10-200 mg/day by age group
  • 6 month treatment period(~182 days)
Study Arms  ICMJE Experimental: A
Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2010)		40
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2008)		48
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term treatment.
  • Study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods.

Exclusion Criteria:

  • Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of the preceding study 3151A6-2000.
  • Unresolved clinically significant adverse events or serious adverse events in the preceding study 3151A6-2000.
  • Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator and the medical monitor.
  • Other exclusion criteria apply.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669110
Other Study ID Numbers  ICMJE 3151A6-2001
B2061013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP