Clinical trial NCT00669110: Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major Depressive Disorder
Keywords: MDD
Depression
Pediatrics
Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Extension study) up to Extension study Week 29 Follow up visit
measure: Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
timeFrame: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)
Secondary outcomes:
Other outcomes:
measure: Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit
timeFrame: Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)
measure: Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
measure: Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
timeFrame: Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
measure: Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
timeFrame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
measure: Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
timeFrame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
measure: Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
timeFrame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
measure: Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
timeFrame: Baseline (Extension study), Week 26 (Extension study)
measure: Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
timeFrame: Baseline (Extension study), Week 26 (Extension study)
measure: Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
measure: Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
measure: Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
measure: Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
measure: Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
measure: Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
timeFrame: Baseline (Extension study) up to Week 26 (Extension study)
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: