Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00669110
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : May 16, 2011
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major Depressive Disorder
Intervention Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Enrollment 40
Recruitment Details Eligible participants transitioned from preceding Core study NCT00619619 (3151A6-2000 [B2061012]) on Day 56 to this Extension study NCT00669110 (3151A6-2001 [B2061013]) to continue treatment on a flexible dose schedule. A total of 8 participants (Children n=2 and Adolescent n=6) discontinued during Taper/post-study or Follow-up phase of Core study.
Pre-assignment Details Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619. Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Period Title: Overall Study
Started 20 20
Completed 12 7
Not Completed 8 13
Reason Not Completed
Adverse Event             4             3
Caregiver request             3             2
Physician Decision             0             1
Lost to Follow-up             1             0
Protocol Violation             0             5
Withdrawal by Subject             0             2
Arm/Group Title DVS SR - Children DVS SR - Adolescents Total
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619. Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
9.65  (1.31) 13.55  (1.64) 11.60  (2.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
11
  55.0%
9
  45.0%
20
  50.0%
Male
9
  45.0%
11
  55.0%
20
  50.0%
Number of participants for Tanner Assessment: Females   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Breasts Stage 1 4 0 4
Breasts Stage 2 4 1 5
Breasts Stage 3 1 0 1
Breasts Stage 4 0 1 1
Breasts Stage 5 0 7 7
Pubic hair Stage 1 6 0 6
Pubic hair Stage 2 3 2 5
Pubic hair Stage 3 0 0 0
Pubic hair Stage 4 0 2 2
Pubic hair Stage 5 0 5 5
[1]
Measure Description: Female pubertal development of secondary sexual characteristics documented 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). N=9 Children, 9 Adolescent participants at observation. Participants may be represented in more than 1 test category.
Number of participants for Tanner Assessment: Males   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Penis Stage 1 5 0 5
Penis Stage 2 3 2 5
Penis Stage 3 1 2 3
Penis Stage 4 0 3 3
Penis Stage 5 0 3 3
Pubic hair Stage 1 6 0 6
Pubic hair Stage 2 2 1 3
Pubic hair Stage 3 1 3 4
Pubic hair Stage 4 0 4 4
Pubic hair Stage 5 0 2 2
Testes Stage 1 5 0 5
Testes Stage 2 2 1 3
Testes Stage 3 2 3 5
Testes Stage 4 0 3 3
Testes Stage 5 0 3 3
[1]
Measure Description: Male pubertal development of secondary sexual characteristics documented by size of genitalia and pubic hair development (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity, size). N=9 Children, 10 Adolescent participants at observation. Participants may be represented in > than 1 test category.
1.Primary Outcome
Title Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline (Extension study) up to Extension study Week 29 Follow up visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Adverse events 13 15
Serious adverse events 1 0
2.Primary Outcome
Title Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Hide Description 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.
Time Frame Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Completed suicide: No 20 20
Suicide attempt: No 20 20
Preparatory acts - imminent suicidal behavior: No 20 20
Suicidal ideation: Yes 0 3
Suicidal ideation: No 20 17
Any suicidal behavior and/or ideation: Yes 0 3
Any suicidal behavior and/or ideation: No 20 17
Self-injurious behavior, no suicidal intent: No 20 20
3.Other Pre-specified Outcome
Title Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline mean 32.40  (7.61) 33.70  (6.34)
Change from Bsl Outpatient Week 26 -1.85  (5.51) -1.95  (6.85)
Change from Bsl Outpatient Week >26 -1.85  (5.51) -1.70  (6.67)
4.Other Pre-specified Outcome
Title Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)
Hide 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. Remission defined as a CDRS-R total score ≤28 (coded value of 1).
Time Frame Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Outpatient Week 1 26.7 21.1
Outpatient Week 2 30 25
Outpatient Week 4 30 20
Outpatient Week 6 25 25
Outpatient Week 10 45 25
Outpatient Week 14 25 25
Outpatient Week 18 35 40
Outpatient Week 22 30 35
Outpatient Week 26 30 30
Outpatient Week >26 30 25
5.Other Pre-specified Outcome
Title Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline mean 5.15  (3.01) 7.45  (4.10)
Change from Bsl Outpatient Week 1 0.53  (2.72) 1.79  (2.97)
Change from Bsl Outpatient Week 2 -0.50  (2.80) 0.70  (3.01)
Change from Bsl Outpatient Week 4 -0.40  (2.28) -0.95  (2.24)
Change from Bsl Outpatient Week 6 -0.45  (2.31) -0.70  (2.68)
Change from Bsl Outpatient Week 10 -1.30  (3.06) -1.40  (2.66)
Change from Bsl Outpatient Week 14 -0.45  (2.58) -1.65  (3.08)
Change from Bsl Outpatient Week 18 -1.65  (2.48) -2.45  (3.10)
Change from Bsl Outpatient Week 22 -1.05  (2.26) -2.15  (3.22)
Change from Bsl Outpatient Week 26 -1.65  (2.94) -2.35  (3.39)
Change from Bsl Outpatient Week >26 -1.65  (2.94) -2.10  (3.37)
6.Other Pre-specified Outcome
Title Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Outpatient Week 1: not ill at all 13.3 10.5
Outpatient Week 1: borderline ill 53.3 10.5
Outpatient Week 1: mildly ill 26.7 57.9
Outpatient Week 1: moderately ill 6.7 21.1
Outpatient Week 2: not ill at all 10 10
Outpatient Week 2: borderline ill 40 20
Outpatient Week 2: mildly ill 45 45
Outpatient Week 2: moderately ill 5 25
Outpatient Week 4: not ill at all 10 10
Outpatient Week 4: borderline ill 50 30
Outpatient Week 4: mildly ill 30 35
Outpatient Week 4: moderately ill 10 25
Outpatient Week 6: not ill at all 10 10
Outpatient Week 6: borderline ill 40 20
Outpatient Week 6: mildly ill 45 50
Outpatient Week 6: moderately ill 5 20
Outpatient Week 10: not ill at all 15 10
Outpatient Week 10: borderline ill 45 35
Outpatient Week 10: mildly ill 35 45
Outpatient Week 10: moderately ill 5 10
Outpatient Week 14: not ill at all 5 5
Outpatient Week 14: borderline ill 55 55
Outpatient Week 14: mildly ill 35 30
Outpatient Week 14: moderately ill 5 10
Outpatient Week 18: not ill at all 5 5
Outpatient Week 18: borderline ill 70 55
Outpatient Week 18: mildly ill 20 35
Outpatient Week 18: moderately ill 5 5
Outpatient Week 22: not ill at all 5 5
Outpatient Week 22: borderline ill 60 55
Outpatient Week 22: mildly ill 30 35
Outpatient Week 22: moderately ill 5 5
Outpatient Week 26: not ill at all 5 5
Outpatient Week 26: borderline ill 75 50
Outpatient Week 26: mildly ill 15 40
Outpatient Week 26: moderately ill 5 5
Outpatient Week >26: not ill at all 5 5
Outpatient Week >26: borderline ill 75 50
Outpatient Week >26: mildly ill 15 40
Outpatient Week >26: moderately ill 5 5
7.Other Pre-specified Outcome
Title Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Outpatient Week 1: very much improved 25 10
Outpatient Week 1: much improved 55 45
Outpatient Week 1: minimally improved 20 40
Outpatient Week 1: minimally worse 0.0 5
Outpatient Week 2: very much improved 25 15
Outpatient Week 2: much improved 55 55
Outpatient Week 2: minimally improved 15 30
Outpatient Week 4: very much improved 35 20
Outpatient Week 4: much improved 45 55
Outpatient Week 4: minimally improved 15 25
Outpatient Week 4: minimally worse 5 0
Outpatient Week 6: very much improved 35 20
Outpatient Week 6: much improved 35 65
Outpatient Week 6: minimally improved 30 15
Outpatient Week 10: very much improved 30 30
Outpatient Week 10: much improved 40 50
Outpatient Week 10: minimally improved 30 15
Outpatient Week 10: no change 0.0 5
Outpatient Week 14: very much improved 25 40
Outpatient Week 14: much improved 50 40
Outpatient Week 14: minimally improved 20 15
Outpatient Week 14: no change 5 5
Outpatient Week 18: very much improved 30 40
Outpatient Week 18: much improved 55 45
Outpatient Week 18: minimally improved 15 15
Outpatient Week 22: very much improved 30 45
Outpatient Week 22: much improved 50 40
Outpatient Week 22: minimally improved 20 15
Outpatient Week 26: very much improved 40 40
Outpatient Week 26: much improved 45 45
Outpatient Week 26: minimally improved 15 15
Outpatient Week >26: very much improved 40 40
Outpatient Week >26: much improved 45 45
Outpatient Week >26: minimally improved 15 15
8.Other Pre-specified Outcome
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Outpatient Week 1 80 55
Outpatient Week 2 80 70
Outpatient Week 4 80 75
Outpatient Week 6 70 85
Outpatient Week 10 70 80
Outpatient Week 14 75 80
Outpatient Week 18 85 85
Outpatient Week 22 80 85
Outpatient Week 26 85 85
Outpatient Week >26 85 85
9.Other Pre-specified Outcome
Title Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 7 3
Measure Type: Number
Unit of Measure: participants
Breasts: 0=no stage change 5 1
Breasts: 1=change of 1 stage 1 1
Breasts: 2=change of 2 stages 1 1
Pubic hair: 0=no stage change 6 2
Pubic hair: 1=change of 1 stage 1 0
Pubic hair: 2=change of 2 stages 0 1
10.Other Pre-specified Outcome
Title Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 5 4
Measure Type: Number
Unit of Measure: participants
Penis: 0=no stage change 4 3
Penis: 1=change of 1 stage 1 0
Penis: 2=change of 2 stages 0 1
Pubic hair: 0=no stage change 2 2
Pubic hair: 1=change of 1 stage 3 1
Pubic hair: 2=change of 2 stages 0 1
Testes: 0=no stage change 3 3
Testes: 1=change of 1 stage 2 0
Testes: 2=change of 2 stages 0 1
11.Other Pre-specified Outcome
Title Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
Hide 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 Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study).
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Elevated supine SBP, 3 consecutive visits 4 0
Decrease SBP ≥20 mmHg supine to standing 2 0
Decrease DBP ≥15 mmHg supine to standing 0 3
12.Other Pre-specified Outcome
Title Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight
Hide Description Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.
Time Frame Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study).
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Increase ≥7 percent in body weight 11 4
Decrease of ≥3.5 percent in body weight 1 3
13.Other Pre-specified Outcome
Title Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
Hide Description PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]).
Time Frame Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study).
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Low supine pulse rate 1 2
Increase in pulse rate ≥20 mmHg supine to standing 14 12
14.Other Pre-specified Outcome
Title Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
Hide Description ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.
Time Frame Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in >1 category.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
PR interval ≥200 msec 0 1
QRS interval ≥120 msec 0 1
QTcF interval ≥30 msec change from baseline 5 1
QTcB interval ≥30 msec change from baseline 6 1
QTcB interval ≥60 msec change from baseline 1 0
QTcB interval >470 or increase ≥60 msec (females) 1 0
15.Other Pre-specified Outcome
Title Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)
Hide Description PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).
Time Frame Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
0 2
16.Other Pre-specified Outcome
Title Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)
Hide Description Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.
Time Frame Baseline (Extension study) up to Week 26 (Extension study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in >1 category.
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description:
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
Bicarbonate: increase 2 0
Bicarbonate: decrease 0 1
Hematocrit: low 4 2
HDL cholesterol: decrease 2 1
Triglycerides: high 4 1
Urine specific gravity: high 3 3
Urine protein albumin: positive result 9 9
Urine ketones: positive result 0 1
Urine hemoglobin: positive result 0 1
Time Frame Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title DVS SR - Children DVS SR - Adolescents
Hide Arm/Group Description Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619. Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
All-Cause Mortality
DVS SR - Children DVS SR - Adolescents
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR - Children DVS SR - Adolescents
Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   0/20 (0.00%) 
Psychiatric disorders     
Negativism (oppositional behavior) * 1  1/20 (5.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DVS SR - Children DVS SR - Adolescents
Affected / at Risk (%) Affected / at Risk (%)
Total   13/20 (65.00%)   15/20 (75.00%) 
Eye disorders     
Ocular hyperaemia  1  0/20 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  4/20 (20.00%)  3/20 (15.00%) 
Diarrhoea  1  0/20 (0.00%)  1/20 (5.00%) 
Flatulence  1  1/20 (5.00%)  0/20 (0.00%) 
Lip swelling  1  1/20 (5.00%)  0/20 (0.00%) 
Nausea  1  2/20 (10.00%)  4/20 (20.00%) 
Vomiting  1  2/20 (10.00%)  2/20 (10.00%) 
General disorders     
Asthenia  1  0/20 (0.00%)  1/20 (5.00%) 
Feeling jittery  1  0/20 (0.00%)  1/20 (5.00%) 
Immune system disorders     
Seasonal allergy  1  0/20 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Adenoiditis  1  0/20 (0.00%)  1/20 (5.00%) 
Chlamydial infection  1  0/20 (0.00%)  1/20 (5.00%) 
Gastroenteritis viral  1  0/20 (0.00%)  1/20 (5.00%) 
Gastroenteritis viral infection  1  0/20 (0.00%)  1/20 (5.00%) 
Localised infection  1  1/20 (5.00%)  0/20 (0.00%) 
Lymph gland infection  1  1/20 (5.00%)  0/20 (0.00%) 
Nasopharyngitis  1  1/20 (5.00%)  2/20 (10.00%) 
Sinusitis  1  1/20 (5.00%)  2/20 (10.00%) 
Tonsillitis  1  0/20 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Intentional overdose  1  0/20 (0.00%)  1/20 (5.00%) 
Joint sprain  1  1/20 (5.00%)  1/20 (5.00%) 
Laceration  1  1/20 (5.00%)  0/20 (0.00%) 
Muscle strain  1  0/20 (0.00%)  1/20 (5.00%) 
Procedural pain  1  0/20 (0.00%)  1/20 (5.00%) 
Skin laceration  1  0/20 (0.00%)  2/20 (10.00%) 
Investigations     
Electrocardiogram abnormal  1  0/20 (0.00%)  1/20 (5.00%) 
Heart rate increased  1  1/20 (5.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/20 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Disturbance in attention  1  1/20 (5.00%)  0/20 (0.00%) 
Dizziness  1  0/20 (0.00%)  2/20 (10.00%) 
Headache  1  4/20 (20.00%)  5/20 (25.00%) 
Psychomotor hyperactivity  1  1/20 (5.00%)  0/20 (0.00%) 
Somnolence  1  1/20 (5.00%)  6/20 (30.00%) 
Syncope  1  0/20 (0.00%)  1/20 (5.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1 [1]  0/11 (0.00%)  1/9 (11.11%) 
Psychiatric disorders     
Aggression  1  2/20 (10.00%)  0/20 (0.00%) 
Depressive symptom  1  0/20 (0.00%)  1/20 (5.00%) 
Insomnia  1  0/20 (0.00%)  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/20 (5.00%)  1/20 (5.00%) 
Cough  1  2/20 (10.00%)  0/20 (0.00%) 
Oropharyngeal pain  1  2/20 (10.00%)  1/20 (5.00%) 
Sinus congestion  1  1/20 (5.00%)  1/20 (5.00%) 
Upper respiratory tract congestion  1  1/20 (5.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/20 (5.00%)  0/20 (0.00%) 
Hyperhidrosis  1  0/20 (0.00%)  1/20 (5.00%) 
Rash  1  0/20 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Female population
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00669110     History of Changes
Other Study ID Numbers: 3151A6-2001
B2061013
First Submitted: April 25, 2008
First Posted: April 29, 2008
Results First Submitted: April 21, 2011
Results First Posted: May 16, 2011
Last Update Posted: May 16, 2011