Expired Study
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Wichita, Kansas 67211


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

3151A6-2001


NCT ID:

NCT00669110


Secondary ID:

B2061013


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

7 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wyeth


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Wyeth

Study Dates

Start Date:May 2008
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 7, 2010
First Received Date:April 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety: Descriptive statistics for AEs, vital sign measurements, Tanner Assessment scores, laboratory evaluations, and ECG data; Columbia Suicide-Severity Rating Scale data
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Efficacy: CDRS-R mean change from baseline.
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:HAM-D17 mean change from baseline.
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:CGI-S proportions of subjects in each category at each time point.
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:CGI-I proportions of subjects in each category at each time point.
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Desvenlafaxine Succinate Sustained-Release Tablets
Description:tablet subjects randomly assigned to 10-200 mg/day by age group 6 month treatment period(~182 days)
Arm Name:A

Study Arms

Study Arm Type:Experimental
Arm Name:A

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wyeth
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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