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

Primary Purpose

Depressive Disorder, Major Depressive Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

About this trial

This is an interventional treatment trial for Depressive Disorder, Major Depressive Disorder focused on measuring MDD, Depression, Pediatrics, Major Depressive Disorder

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)

AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.

Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

Secondary Outcome Measures

Full Information

NCT ID

NCT00669110

First Posted

April 25, 2008

Last Updated

August 17, 2021

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00669110

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major Depressive Disorder

Keywords

MDD, Depression, Pediatrics, Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Intervention Description

tablet subjects randomly assigned to 10-200 mg/day by age group 6 month treatment period(~182 days)

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline (Extension study) up to Extension study Week 29 Follow up visit

Title

Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

Description

Time Frame

Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)

Other Pre-specified Outcome Measures:

Title

Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit

Description

CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.

Time Frame

Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)

Title

Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)

Description

Time Frame

Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)

Title

Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score

Description

HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.

Time Frame

Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)

Title

Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score

Description

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.

Time Frame

Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)

Title

Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score

Description

CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.

Time Frame

Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)

Title

Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score

Description

CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).

Time Frame

Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)

Title

Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females

Description

Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.

Time Frame

Baseline (Extension study), Week 26 (Extension study)

Title

Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males

Description

Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.

Time Frame

Baseline (Extension study), Week 26 (Extension study)

Title

Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)

Description

PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]).

Time Frame