Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Desvenlafaxine Succinate Sustained-Release (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: NCT00619619
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : February 21, 2011
Last Update Posted : February 23, 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)
Conditions Depression
Major Depressive Disorder
Intervention Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Enrollment 59
Recruitment Details Treatment to be given at only 1 dose level at a time for at least the first 6 subjects per dose group. Approximately 6 to 8 subjects were to be enrolled in each of the dose cohorts; 4 dose levels were to be evaluated per age stratum in sequential manner and ascending order (10 to 100 milligrams (mg) for children; 25 to 200 mg for adolescents).
Pre-assignment Details Screening period 6 to 14 days followed by treatment period (up to 3.5 day inpatient and up to 7.5 week outpatient phase). Participants who enter outpatient period but do not continue into 6-month open-label extension study (NCT00669110) will participate in taper period of 0 to 2 weeks depending on dose of study treatment to which they are assigned.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description Desvenlafaxine sustained release 10 milligram (mg) tablet Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Period Title: Overall Study
Started 6 7 9 7 7 7 8 8
Entered the Extension Study 6 [1] 5 8 3 7 6 6 7
Completed 6 [2] 7 8 6 5 7 7 5
Not Completed 0 0 1 1 2 0 1 3
Reason Not Completed
Physician Decision             0             0             1             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             1             1
Adverse Event             0             0             0             0             2             0             0             2
[1]
Extension study: 3151A6-2001 (NCT00669110)
[2]
Completed=conclusion of Test Article (treatment) phase for all treatment groups in 3151A6-2000.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent Total
Hide Arm/Group Description Desvenlafaxine sustained release 10 milligram (mg) tablet Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14. Total of all reporting groups
Overall Number of Baseline Participants 6 7 9 7 7 7 8 8 59
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 9 participants 7 participants 7 participants 7 participants 8 participants 8 participants 59 participants
8.83  (1.33) 9.57  (1.13) 9.89  (1.27) 9.71  (0.95) 15.00  (1.83) 13.14  (1.46) 14.25  (1.67) 14.00  (1.60) 11.86  (2.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 9 participants 7 participants 7 participants 7 participants 8 participants 8 participants 59 participants
Female
4
  66.7%
3
  42.9%
3
  33.3%
4
  57.1%
4
  57.1%
3
  42.9%
3
  37.5%
5
  62.5%
29
  49.2%
Male
2
  33.3%
4
  57.1%
6
  66.7%
3
  42.9%
3
  42.9%
4
  57.1%
5
  62.5%
3
  37.5%
30
  50.8%
Children's Depression Ratings Scale-Revised (CDRS-R) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 6 participants 7 participants 9 participants 7 participants 7 participants 7 participants 8 participants 8 participants 59 participants
57.50  (4.89) 52.43  (5.13) 49.89  (7.30) 46.43  (4.35) 64.86  (11.87) 57.71  (1.98) 57.88  (9.19) 48.63  (6.25) 54.17  (8.78)
[1]
Measure 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 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.
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 to Follow-up (up to Day 77)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 0 0 0 0 1 0 0 0
Non-serious Adverse Events 1 3 3 7 4 2 7 8
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).
Time Frame Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
33.9  (12.1) 98  (60.5) 108  (27) 263  (66) 46.1  (15.9) 93.9  (15.5) 202  (92) 449  (126)
3.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Time Frame Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: hr
4.7  (2.1) 4.3  (1.4) 5.1  (3) 5.0  (2.0) 4.3  (0.7) 8.7  (7.1) 7.6  (3.4) 7.5  (4.1)
4.Primary Outcome
Title Plasma Decay Half-Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
Time Frame Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: hr
7.8  (1.4) 8.6  (1.6) 9.4  (2.7) 9.0  (2.0) 12  (3) 10.2  (3.7) 9.6  (2.0) 9.8  (2.7)
5.Primary Outcome
Title Area Under the Curve From Time Zero to Infinity (AUC0-∞)
Hide Description AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Time Frame Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 8 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
628  (346) 1704  (553) 2414  (924) 6732  (3031) 1123  (361) 2281  (689) 5290  (2188) 11730  (3113)
6.Secondary Outcome
Title Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method
Hide Description Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].
Time Frame Day 1, Day 28, and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
Arm/Group Title Desvenlafaxine – Combined Children Cohorts Desvenlafaxine – Combined Adolescent Cohorts
Hide Arm/Group Description:
Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method
Hide Description Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].
Time Frame Day 1, Day 28, and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
Arm/Group Title Desvenlafaxine - Combined Children and Adolescent Cohorts
Hide Arm/Group Description:
Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
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 or 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, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Inpatient Days 1 to 4 -6.83  (6.15) -9.86  (5.40) -2.78  (3.07) -6.43  (10.00) -7.00  (18.18) -4.57  (2.99) -8.25  (4.33) -10.38  (13.45)
Outpatient Days 5 to 7 -10.67  (6.44) -13.86  (8.51) -10.44  (10.79) -7.86  (8.28) -8.00  (13.88) -8.29  (4.27) -9.50  (8.11) -11.25  (14.00)
Outpatient Week 2 -17.67  (6.92) -18.86  (10.51) -14.44  (12.68) -9.57  (10.83) -8.29  (13.46) -11.29  (5.53) -18.13  (11.12) -13.13  (14.88)
Outpatient Week 3 -19.67  (6.77) -18.57  (7.93) -16.89  (13.49) -10.43  (9.11) -11.71  (13.23) -14.57  (6.19) -21.25  (10.99) -13.13  (11.47)
Outpatient Week 4 -19.50  (6.50) -20.86  (10.98) -17.56  (15.99) -10.00  (4.69) -14.57  (14.06) -19.43  (9.43) -23.50  (10.69) -12.50  (9.41)
Outpatient Week 5 -19.50  (6.50) -23.00  (8.56) -19.56  (13.46) -10.29  (4.39) -14.57  (14.06) -19.43  (9.43) -23.88  (10.36) -12.50  (9.41)
Outpatient Week 6 -21.83  (6.77) -19.86  (9.94) -18.44  (13.79) -12.00  (5.48) -20.57  (18.98) -17.14  (6.20) -24.63  (8.99) -14.38  (9.93)
Outpatient Week 7 -21.83  (6.77) -20.43  (10.06) -19.11  (13.20) -12.00  (5.48) -20.57  (18.98) -17.14  (6.20) -25.38  (7.87) -14.50  (9.89)
Outpatient Week 8 -22.00  (7.01) -20.29  (7.18) -19.78  (14.49) -14.14  (6.52) -21.43  (19.86) -22.29  (3.09) -27.25  (6.78) -15.38  (8.65)
Outpatient Week >8 -22.00  (7.01) -20.00  (7.05) -19.89  (14.51) -14.14  (6.52) -21.43  (19.86) -22.29  (3.09) -26.75  (7.42) -15.38  (8.65)
9.Other Pre-specified Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Hide Description HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.
Time Frame Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Inpatient Days 1 to 4 -6.00  (5.73) -5.43  (4.31) -0.33  (1.94) -2.43  (6.92) -2.29  (7.45) -0.57  (1.13) -1.50  (4.54) -5.63  (7.42)
Outpatient Days 5 to 7 -6.00  (5.73) -5.43  (4.31) -0.33  (1.94) -2.43  (6.92) -2.00  (7.59) -0.57  (1.13) -1.50  (4.54) -5.63  (7.42)
Outpatient Week 2 -9.33  (7.00) -10.71  (4.61) -6.11  (2.67) -5.57  (4.20) -2.71  (4.27) -5.71  (3.40) -8.13  (4.91) -9.38  (7.41)
Outpatient Week 3 -9.33  (7.00) -10.29  (5.41) -6.11  (2.67) -5.57  (4.20) -2.71  (4.27) -5.71  (3.40) -8.13  (4.91) -8.88  (6.33)
Outpatient Week 4 -11.00  (5.62) -13.00  (6.30) -7.22  (5.61) -7.57  (3.05) -7.29  (5.19) -7.57  (2.99) -12.13  (5.69) -9.00  (5.24)
Outpatient Week 5 -11.00  (5.62) -14.14  (4.10) -7.56  (5.64) -9.00  (1.91) -7.29  (5.19) -7.57  (2.99) -12.25  (5.73) -9.00  (5.24)
Outpatient Week 8 -12.17  (6.01) -14.00  (4.62) -8.44  (6.88) -11.14  (4.14) -11.14  (9.56) -9.86  (3.93) -14.25  (3.96) -11.63  (5.40)
Outpatient Week >8 -12.17  (6.01) -13.86  (4.81) -9.11  (6.68) -11.14  (4.14) -11.14  (9.56) -9.86  (3.93) -13.00  (5.37) -11.63  (5.40)
10.Other Pre-specified Outcome
Title Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
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 Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Measure Type: Number
Unit of Measure: percentage of participants
Inpatient Days 1 to 4: not ill at all 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Inpatient Days 1 to 4: borderline ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Inpatient Days 1 to 4: mildly ill 0.0 0.0 0.0 14.3 0.0 0.0 0.0 12.5
Inpatient Days 1 to 4: moderately ill 100 100 88.9 85.7 100 100 100 87.5
Inpatient Days 1 to 4: markedly ill 0.0 0.0 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Days 5 to 7: not ill at all 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Days 5 to 7: borderline ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Days 5 to 7: mildly ill 0.0 42.9 44.4 0.0 0.0 14.3 0.0 12.5
Outpatient Days 5 to 7: moderately ill 100 57.1 55.6 100 100 85.7 100 87.5
Outpatient Days 5 to 7: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 2: not ill at all 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 2: borderline ill 0.0 14.3 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 2: mildly ill 66.7 57.1 55.6 0.0 0.0 28.6 50 12.5
Outpatient Week 2: moderately ill 33.3 28.6 33.3 100 100 71.4 50 87.5
Outpatient Week 2: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 3: not ill at all 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 3: borderline ill 0.0 57.1 0.0 0.0 0.0 0.0 25 0.0
Outpatient Week 3: mildly ill 66.7 42.9 88.9 0.0 28.6 57.1 37.5 12.5
Outpatient Week 3: moderately ill 33.3 0.0 11.1 100 71.4 42.9 37.5 87.5
Outpatient Week 3: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 4: not ill at all 0.0 14.3 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 4: borderline ill 16.7 57.1 11.1 0.0 0.0 0.0 50 0.0
Outpatient Week 4: mildly ill 66.7 28.6 66.7 14.3 28.6 85.7 12.5 37.5
Outpatient Week 4: moderately ill 16.7 0.0 22.2 85.7 71.4 14.3 37.5 62.5
Outpatient Week 4: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 5: not ill at all 0.0 14.3 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 5: borderline ill 16.7 57.1 11.1 0.0 0.0 0.0 50 0.0
Outpatient Week 5: mildly ill 66.7 28.6 55.6 14.3 28.6 85.7 12.5 37.5
Outpatient Week 5: moderately ill 16.7 0.0 22.2 85.7 71.4 14.3 37.5 62.5
Outpatient Week 5: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 6: not ill at all 0.0 0.0 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 6: borderline ill 50 57.1 11.1 0.0 0.0 14.3 62.5 0.0
Outpatient Week 6: mildly ill 50 42.9 66.7 28.6 57.1 57.1 12.5 50
Outpatient Week 6: moderately ill 0.0 0.0 11.1 71.4 42.9 28.6 25 50
Outpatient Week 6: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 7: not ill at all 0.0 0.0 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 7: borderline ill 50 42.9 11.1 0.0 0.0 14.3 62.5 0.0
Outpatient Week 7: mildly ill 50 57.1 77.8 28.6 57.1 57.1 25 50
Outpatient Week 7: moderately ill 0.0 0.0 0.0 71.4 42.9 28.6 12.5 50
Outpatient Week 7: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 8: not ill at all 0.0 0.0 11.1 0.0 0.0 0.0 12.5 0.0
Outpatient Week 8: borderline ill 66.7 42.9 22.2 0.0 0.0 28.6 50 0.0
Outpatient Week 8: mildly ill 33.3 57.1 66.7 71.4 57.1 71.4 25 62.5
Outpatient Week 8: moderately ill 0.0 0.0 0.0 28.6 42.9 0.0 12.5 37.5
Outpatient Week 8: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week >8: not ill at all 0.0 0.0 11.1 0.0 0.0 0.0 12.5 0.0
Outpatient Week >8: borderline ill 66.7 57.1 33.3 0.0 0.0 28.6 50 0.0
Outpatient Week >8: mildly ill 33.3 42.9 55.6 71.4 57.1 71.4 25 62.5
Outpatient Week >8: moderately ill 0.0 0.0 0.0 28.6 42.9 0.0 12.5 37.5
Outpatient Week >8: markedly ill 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
11.Other Pre-specified Outcome
Title Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
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, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description:
Desvenlafaxine sustained release 10 milligram (mg) tablet
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
Overall Number of Participants Analyzed 6 7 9 7 7 7 8 8
Measure Type: Number
Unit of Measure: percentage of participants
Inpatient Days 1 to 4: very much improved 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Inpatient Days 1 to 4: much improved 0.0 0.0 0.0 14.3 14.3 0.0 0.0 12.5
Inpatient Days 1 to 4: minimally improved 0.0 0.0 11.1 0.0 0.00 0.0 12.5 37.5
Inpatient Days 1 to 4: no change 100 100 88.9 85.7 85.7 100 87.5 50
Inpatient Days 1 to 4: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Days 5 to 7: very much improved 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Days 5 to 7: much improved 0.0 14.3 11.1 0.0 0.0 0.0 0.0 12.5
Outpatient Days 5 to 7: minimally improved 50 14.3 55.6 42.9 42.9 57.1 25 25
Outpatient Days 5 to 7: no change 50 71.4 33.3 57.1 57.1 42.9 75 62.5
Outpatient Days 5 to 7: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 2: very much improved 0.0 0.0 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 2: much improved 33.3 28.6 44.4 14.3 0.0 0.0 0.0 25
Outpatient Week 2: minimally improved 50 42.9 11.1 42.9 42.9 57.1 75 50
Outpatient Week 2: no change 16.7 28.6 33.3 42.9 57.1 42.9 25 25
Outpatient Week 2: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 3: very much improved 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 3: much improved 50 85.7 44.4 14.3 28.6 0.0 37.5 25
Outpatient Week 3: minimally improved 50 14.3 44.4 57.1 57.1 71.4 37.5 62.5
Outpatient Week 3: no change 0.0 0.0 11.1 28.6 14.3 28.6 25 12.5
Outpatient Week 3: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 4: very much improved 0.0 14.3 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 4: much improved 50 71.4 55.6 28.6 28.6 0.0 50 37.5
Outpatient Week 4: minimally improved 50 14.3 22.2 57.1 57.1 85.7 37.5 37.5
Outpatient Week 4: no change 0.0 0.0 11.1 14.3 14.3 14.3 12.5 12.5
Outpatient Week 4: minimally worse 0.0 0.0 11.1 0.0 0.0 0.0 0.0 12.5
Outpatient Week 5: very much improved 0.0 14.3 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 5: much improved 50 85.7 55.6 28.6 28.6 0.0 50 37.5
Outpatient Week 5: minimally improved 50 0.0 22.2 71.4 57.1 85.7 37.5 37.5
Outpatient Week 5: no change 0.0 0.0 0.0 0.0 14.3 14.3 12.5 12.5
Outpatient Week 5: minimally worse 0.0 0.0 11.1 0.0 0.0 0.0 0.0 12.5
Outpatient Week 6: very much improved 0.0 14.3 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 6: much improved 50 57.1 66.7 28.6 57.1 71.4 75 50
Outpatient Week 6: minimally improved 50 28.6 22.2 71.4 28.6 28.6 12.5 25
Outpatient Week 6: no change 0.0 0.0 0.0 0.0 14.3 0.0 12.5 25
Outpatient Week 6: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 7: very much improved 0.0 14.3 11.1 0.0 0.0 0.0 0.0 0.0
Outpatient Week 7: much improved 50 42.9 55.6 28.6 57.1 71.4 75 50
Outpatient Week 7: minimally improved 50 42.9 33.3 71.4 28.6 28.6 12.5 37.5
Outpatient Week 7: no change 0.0 0.0 0.0 0.0 14.3 0.0 12.5 12.5
Outpatient Week 7: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week 8: very much improved 0.0 14.3 22.2 0.0 0.0 0.0 12.5 0.0
Outpatient Week 8: much improved 83.3 71.4 22.2 71.4 57.1 71.4 75 62.5
Outpatient Week 8: minimally improved 16.7 14.3 55.6 28.6 28.6 28.6 0.0 37.5
Outpatient Week 8: no change 0.0 0.0 0.0 0.0 14.3 0.0 12.5 0.0
Outpatient Week 8: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Outpatient Week >8: very much improved 0.0 14.3 22.2 0.0 0.0 0.0 12.5 0.0
Outpatient Week >8: much improved 83.3 71.4 33.3 71.4 57.1 71.4 75 62.5
Outpatient Week >8: minimally improved 16.7 14.3 44.4 28.6 28.6 28.6 0.0 37.5
Outpatient Week >8: no change 0.0 0.0 0.0 0.0 14.3 0.0 12.5 0.0
Outpatient Week >8: minimally worse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
 
Arm/Group Title Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Hide Arm/Group Description Desvenlafaxine sustained release 10 milligram (mg) tablet Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper. Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14. Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
All-Cause Mortality
Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/7 (0.00%)   1/7 (14.29%)   0/7 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Psychiatric disorders                 
Suicidal behaviour  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Indicates events were collected by 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%
Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   3/7 (42.86%)   3/9 (33.33%)   7/7 (100.00%)   4/7 (57.14%)   2/7 (28.57%)   7/8 (87.50%)   8/8 (100.00%) 
Eye disorders                 
Vision blurred  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Ocular hyperaemia  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain upper  1  0/6 (0.00%)  1/7 (14.29%)  2/9 (22.22%)  2/7 (28.57%)  2/7 (28.57%)  0/7 (0.00%)  0/8 (0.00%)  2/8 (25.00%) 
Constipation  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nausea  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  2/7 (28.57%)  1/7 (14.29%)  1/7 (14.29%)  0/8 (0.00%)  5/8 (62.50%) 
Vomiting  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  2/7 (28.57%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  2/8 (25.00%) 
Diarrhoea  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Faeces discoloured  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
General disorders                 
Application site irritation  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Asthenia  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Feeling jittery  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Infusion site extravasation  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Immune system disorders                 
Seasonal allergy  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Infections and infestations                 
Gastroenteritis viral  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Gastrointestinal viral infection  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Infectious mononucleosis  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Nasopharyngitis  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Injury, poisoning and procedural complications                 
Intentional overdose  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Skin laceration  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Investigations                 
Heart rate increased  1  0/6 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders                 
Decreased appetite  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Muscle spasms  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Nervous system disorders                 
Dizziness  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Headache  1  1/6 (16.67%)  0/7 (0.00%)  1/9 (11.11%)  3/7 (42.86%)  1/7 (14.29%)  1/7 (14.29%)  2/8 (25.00%)  1/8 (12.50%) 
Somnolence  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  1/7 (14.29%)  2/7 (28.57%)  1/7 (14.29%)  1/8 (12.50%)  4/8 (50.00%) 
Nerve compression  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Psychiatric disorders                 
Affect lability  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Depression  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Insomnia  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%)  0/8 (0.00%) 
Reproductive system and breast disorders                 
Dysmenorrhoea  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  2/7 (28.57%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nasal congestion  1  0/6 (0.00%)  1/7 (14.29%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Oropharyngeal pain  1  0/6 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  2/7 (28.57%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Sinus congestion  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Upper respiratory tract congestion  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Asthma  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Epistaxis  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders                 
Blister  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Rash  1  0/6 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00619619     History of Changes
Other Study ID Numbers: 3151A6-2000
B2061012
3151A6-2000-US
First Submitted: January 28, 2008
First Posted: February 21, 2008
Results First Submitted: November 10, 2010
Results First Posted: February 21, 2011
Last Update Posted: February 23, 2011