Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00619619
Collaborator
(none)
59
9
1
21
6.6
0.3
Study Details
Study Description
Brief Summary
The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
59 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Final Report: Multicenter, Open-Label, Safety, Tolerability, And Pharmacokinetic Study To Evaluate Single Ascending Doses And Subsequent Short-Term Administration Of Fixed Doses Of DVS SR Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) [Baseline to Follow-up (up to Day 77)]
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.
- Maximum Observed Plasma Concentration (Cmax) [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]
Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [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]
Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).
- Plasma Decay Half-Life (t1/2) [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]
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).
- Area Under the Curve From Time Zero to Infinity (AUC0-∞) [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]
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).
Secondary Outcome Measures
- Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method [Day 1, Day 28, and Day 56]
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].
- Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method [Day 1, Day 28, and Day 56]
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].
Other Outcome Measures
- Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score [Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)]
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.
- Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score [Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)]
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.
- Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit [Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)]
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.
- Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit [Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
7 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female outpatient between 7 and 17 years of age at baseline who meet Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision criteria for major depressive disorder.
-
Children's Depression Rating Scale --Revised (CDRS-R) score greater than 40 at the screening and study day -1 (baseline) visits and Clinical Global Impressions Scale--Severity (CGI-S) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
-
Depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
-
Other inclusion criteria apply.
Exclusion Criteria:
-
History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
-
History of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
-
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of MDD with psychotic features.
-
Other exclusion criteria apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 2 | Pfizer Investigational Site | North Miami | Florida | United States | 33161 |
| 3 | Pfizer Investigational Site | Terre Haute | Indiana | United States | 47802 |
| 4 | Pfizer Investigational Site | Wichita | Kansas | United States | 67211 |
| 5 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70114 |
| 6 | Pfizer Investigational Site | New York | New York | United States | 10032 |
| 7 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44106-5080 |
| 8 | Pfizer Investigational Site | Hershey | Pennsylvania | United States | 17033 |
| 9 | Pfizer Investigational Site | Houston | Texas | United States | 77008 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00619619
Other Study ID Numbers:
- 3151A6-2000
- B2061012
- 3151A6-2000-US
First Posted:
Feb 21, 2008
Last Update Posted:
Feb 23, 2011
Last Verified:
Feb 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|---|---|---|---|---|---|---|
| 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 | 5 | 8 | 3 | 7 | 6 | 6 | 7 |
| COMPLETED | 6 | 7 | 8 | 6 | 5 | 7 | 7 | 5 |
| NOT COMPLETED | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 3 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 | 59 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
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 (Count of 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 (scores on a scale) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [scores on a scale] |
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)
|
Outcome Measures
| Title | Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| 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)
|
| Title | Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| 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)
|
| Title | Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Inpatient Days 1 to 4: not ill at all |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Inpatient Days 1 to 4: mildly ill |
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
| Inpatient Days 1 to 4: moderately ill |
100
1666.7%
|
100
1428.6%
|
88.9
987.8%
|
85.7
1224.3%
|
100
1428.6%
|
100
1428.6%
|
100
1250%
|
87.5
1093.8%
|
| Inpatient Days 1 to 4: markedly ill |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
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%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Days 5 to 7: mildly ill |
0.0
0%
|
42.9
612.9%
|
44.4
493.3%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
12.5
156.3%
|
| Outpatient Days 5 to 7: moderately ill |
100
1666.7%
|
57.1
815.7%
|
55.6
617.8%
|
100
1428.6%
|
100
1428.6%
|
85.7
1224.3%
|
100
1250%
|
87.5
1093.8%
|
| Outpatient Days 5 to 7: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 2: borderline ill |
0.0
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 2: mildly ill |
66.7
1111.7%
|
57.1
815.7%
|
55.6
617.8%
|
0.0
0%
|
0.0
0%
|
28.6
408.6%
|
50
625%
|
12.5
156.3%
|
| Outpatient Week 2: moderately ill |
33.3
555%
|
28.6
408.6%
|
33.3
370%
|
100
1428.6%
|
100
1428.6%
|
71.4
1020%
|
50
625%
|
87.5
1093.8%
|
| Outpatient Week 2: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 3: borderline ill |
0.0
0%
|
57.1
815.7%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
25
312.5%
|
0.0
0%
|
| Outpatient Week 3: mildly ill |
66.7
1111.7%
|
42.9
612.9%
|
88.9
987.8%
|
0.0
0%
|
28.6
408.6%
|
57.1
815.7%
|
37.5
468.8%
|
12.5
156.3%
|
| Outpatient Week 3: moderately ill |
33.3
555%
|
0.0
0%
|
11.1
123.3%
|
100
1428.6%
|
71.4
1020%
|
42.9
612.9%
|
37.5
468.8%
|
87.5
1093.8%
|
| Outpatient Week 3: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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
0%
|
14.3
204.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 4: borderline ill |
16.7
278.3%
|
57.1
815.7%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
50
625%
|
0.0
0%
|
| Outpatient Week 4: mildly ill |
66.7
1111.7%
|
28.6
408.6%
|
66.7
741.1%
|
14.3
204.3%
|
28.6
408.6%
|
85.7
1224.3%
|
12.5
156.3%
|
37.5
468.8%
|
| Outpatient Week 4: moderately ill |
16.7
278.3%
|
0.0
0%
|
22.2
246.7%
|
85.7
1224.3%
|
71.4
1020%
|
14.3
204.3%
|
37.5
468.8%
|
62.5
781.3%
|
| Outpatient Week 4: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 5: borderline ill |
16.7
278.3%
|
57.1
815.7%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
50
625%
|
0.0
0%
|
| Outpatient Week 5: mildly ill |
66.7
1111.7%
|
28.6
408.6%
|
55.6
617.8%
|
14.3
204.3%
|
28.6
408.6%
|
85.7
1224.3%
|
12.5
156.3%
|
37.5
468.8%
|
| Outpatient Week 5: moderately ill |
16.7
278.3%
|
0.0
0%
|
22.2
246.7%
|
85.7
1224.3%
|
71.4
1020%
|
14.3
204.3%
|
37.5
468.8%
|
62.5
781.3%
|
| Outpatient Week 5: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 6: borderline ill |
50
833.3%
|
57.1
815.7%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
62.5
781.3%
|
0.0
0%
|
| Outpatient Week 6: mildly ill |
50
833.3%
|
42.9
612.9%
|
66.7
741.1%
|
28.6
408.6%
|
57.1
815.7%
|
57.1
815.7%
|
12.5
156.3%
|
50
625%
|
| Outpatient Week 6: moderately ill |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
71.4
1020%
|
42.9
612.9%
|
28.6
408.6%
|
25
312.5%
|
50
625%
|
| Outpatient Week 6: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 7: borderline ill |
50
833.3%
|
42.9
612.9%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
62.5
781.3%
|
0.0
0%
|
| Outpatient Week 7: mildly ill |
50
833.3%
|
57.1
815.7%
|
77.8
864.4%
|
28.6
408.6%
|
57.1
815.7%
|
57.1
815.7%
|
25
312.5%
|
50
625%
|
| Outpatient Week 7: moderately ill |
0.0
0%
|
0.0
0%
|
0.0
0%
|
71.4
1020%
|
42.9
612.9%
|
28.6
408.6%
|
12.5
156.3%
|
50
625%
|
| Outpatient Week 7: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week 8: borderline ill |
66.7
1111.7%
|
42.9
612.9%
|
22.2
246.7%
|
0.0
0%
|
0.0
0%
|
28.6
408.6%
|
50
625%
|
0.0
0%
|
| Outpatient Week 8: mildly ill |
33.3
555%
|
57.1
815.7%
|
66.7
741.1%
|
71.4
1020%
|
57.1
815.7%
|
71.4
1020%
|
25
312.5%
|
62.5
781.3%
|
| Outpatient Week 8: moderately ill |
0.0
0%
|
0.0
0%
|
0.0
0%
|
28.6
408.6%
|
42.9
612.9%
|
0.0
0%
|
12.5
156.3%
|
37.5
468.8%
|
| Outpatient Week 8: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week >8: borderline ill |
66.7
1111.7%
|
57.1
815.7%
|
33.3
370%
|
0.0
0%
|
0.0
0%
|
28.6
408.6%
|
50
625%
|
0.0
0%
|
| Outpatient Week >8: mildly ill |
33.3
555%
|
42.9
612.9%
|
55.6
617.8%
|
71.4
1020%
|
57.1
815.7%
|
71.4
1020%
|
25
312.5%
|
62.5
781.3%
|
| Outpatient Week >8: moderately ill |
0.0
0%
|
0.0
0%
|
0.0
0%
|
28.6
408.6%
|
42.9
612.9%
|
0.0
0%
|
12.5
156.3%
|
37.5
468.8%
|
| Outpatient Week >8: markedly ill |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Serious Adverse Events |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
0
0%
|
0
0%
|
| Non-serious Adverse Events |
1
16.7%
|
3
42.9%
|
3
33.3%
|
7
100%
|
4
57.1%
|
2
28.6%
|
7
87.5%
|
8
100%
|
| Title | Maximum Observed Plasma Concentration (Cmax) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Mean (Standard Deviation) [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)
|
| Title | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Mean (Standard Deviation) [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)
|
| Title | Plasma Decay Half-Life (t1/2) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Mean (Standard Deviation) [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)
|
| Title | Area Under the Curve From Time Zero to Infinity (AUC0-∞) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 8 | 7 | 7 | 7 | 8 | 8 |
| Mean (Standard Deviation) [ng*hr/mL] |
628
(346)
|
1704
(553)
|
2414
(924)
|
6732
(3031)
|
1123
(361)
|
2281
(689)
|
5290
(2188)
|
11730
(3113)
|
| Title | Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 0 | 0 |
| Title | Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 0 |
| Title | Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 7 | 9 | 7 | 7 | 7 | 8 | 8 |
| Inpatient Days 1 to 4: very much improved |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
14.3
204.3%
|
14.3
204.3%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
| Inpatient Days 1 to 4: minimally improved |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.00
0%
|
0.0
0%
|
12.5
156.3%
|
37.5
468.8%
|
| Inpatient Days 1 to 4: no change |
100
1666.7%
|
100
1428.6%
|
88.9
987.8%
|
85.7
1224.3%
|
85.7
1224.3%
|
100
1428.6%
|
87.5
1093.8%
|
50
625%
|
| Inpatient Days 1 to 4: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Days 5 to 7: much improved |
0.0
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
| Outpatient Days 5 to 7: minimally improved |
50
833.3%
|
14.3
204.3%
|
55.6
617.8%
|
42.9
612.9%
|
42.9
612.9%
|
57.1
815.7%
|
25
312.5%
|
25
312.5%
|
| Outpatient Days 5 to 7: no change |
50
833.3%
|
71.4
1020%
|
33.3
370%
|
57.1
815.7%
|
57.1
815.7%
|
42.9
612.9%
|
75
937.5%
|
62.5
781.3%
|
| Outpatient Days 5 to 7: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 2: much improved |
33.3
555%
|
28.6
408.6%
|
44.4
493.3%
|
14.3
204.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
25
312.5%
|
| Outpatient Week 2: minimally improved |
50
833.3%
|
42.9
612.9%
|
11.1
123.3%
|
42.9
612.9%
|
42.9
612.9%
|
57.1
815.7%
|
75
937.5%
|
50
625%
|
| Outpatient Week 2: no change |
16.7
278.3%
|
28.6
408.6%
|
33.3
370%
|
42.9
612.9%
|
57.1
815.7%
|
42.9
612.9%
|
25
312.5%
|
25
312.5%
|
| Outpatient Week 2: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
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%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 3: much improved |
50
833.3%
|
85.7
1224.3%
|
44.4
493.3%
|
14.3
204.3%
|
28.6
408.6%
|
0.0
0%
|
37.5
468.8%
|
25
312.5%
|
| Outpatient Week 3: minimally improved |
50
833.3%
|
14.3
204.3%
|
44.4
493.3%
|
57.1
815.7%
|
57.1
815.7%
|
71.4
1020%
|
37.5
468.8%
|
62.5
781.3%
|
| Outpatient Week 3: no change |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
28.6
408.6%
|
14.3
204.3%
|
28.6
408.6%
|
25
312.5%
|
12.5
156.3%
|
| Outpatient Week 3: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 4: very much improved |
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 4: much improved |
50
833.3%
|
71.4
1020%
|
55.6
617.8%
|
28.6
408.6%
|
28.6
408.6%
|
0.0
0%
|
50
625%
|
37.5
468.8%
|
| Outpatient Week 4: minimally improved |
50
833.3%
|
14.3
204.3%
|
22.2
246.7%
|
57.1
815.7%
|
57.1
815.7%
|
85.7
1224.3%
|
37.5
468.8%
|
37.5
468.8%
|
| Outpatient Week 4: no change |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
14.3
204.3%
|
14.3
204.3%
|
14.3
204.3%
|
12.5
156.3%
|
12.5
156.3%
|
| Outpatient Week 4: minimally worse |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
| Outpatient Week 5: very much improved |
0.0
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 5: much improved |
50
833.3%
|
85.7
1224.3%
|
55.6
617.8%
|
28.6
408.6%
|
28.6
408.6%
|
0.0
0%
|
50
625%
|
37.5
468.8%
|
| Outpatient Week 5: minimally improved |
50
833.3%
|
0.0
0%
|
22.2
246.7%
|
71.4
1020%
|
57.1
815.7%
|
85.7
1224.3%
|
37.5
468.8%
|
37.5
468.8%
|
| Outpatient Week 5: no change |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
14.3
204.3%
|
12.5
156.3%
|
12.5
156.3%
|
| Outpatient Week 5: minimally worse |
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
| Outpatient Week 6: very much improved |
0.0
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 6: much improved |
50
833.3%
|
57.1
815.7%
|
66.7
741.1%
|
28.6
408.6%
|
57.1
815.7%
|
71.4
1020%
|
75
937.5%
|
50
625%
|
| Outpatient Week 6: minimally improved |
50
833.3%
|
28.6
408.6%
|
22.2
246.7%
|
71.4
1020%
|
28.6
408.6%
|
28.6
408.6%
|
12.5
156.3%
|
25
312.5%
|
| Outpatient Week 6: no change |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
12.5
156.3%
|
25
312.5%
|
| Outpatient Week 6: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 7: very much improved |
0.0
0%
|
14.3
204.3%
|
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 7: much improved |
50
833.3%
|
42.9
612.9%
|
55.6
617.8%
|
28.6
408.6%
|
57.1
815.7%
|
71.4
1020%
|
75
937.5%
|
50
625%
|
| Outpatient Week 7: minimally improved |
50
833.3%
|
42.9
612.9%
|
33.3
370%
|
71.4
1020%
|
28.6
408.6%
|
28.6
408.6%
|
12.5
156.3%
|
37.5
468.8%
|
| Outpatient Week 7: no change |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
12.5
156.3%
|
12.5
156.3%
|
| Outpatient Week 7: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week 8: very much improved |
0.0
0%
|
14.3
204.3%
|
22.2
246.7%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week 8: much improved |
83.3
1388.3%
|
71.4
1020%
|
22.2
246.7%
|
71.4
1020%
|
57.1
815.7%
|
71.4
1020%
|
75
937.5%
|
62.5
781.3%
|
| Outpatient Week 8: minimally improved |
16.7
278.3%
|
14.3
204.3%
|
55.6
617.8%
|
28.6
408.6%
|
28.6
408.6%
|
28.6
408.6%
|
0.0
0%
|
37.5
468.8%
|
| Outpatient Week 8: no change |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week 8: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Outpatient Week >8: very much improved |
0.0
0%
|
14.3
204.3%
|
22.2
246.7%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week >8: much improved |
83.3
1388.3%
|
71.4
1020%
|
33.3
370%
|
71.4
1020%
|
57.1
815.7%
|
71.4
1020%
|
75
937.5%
|
62.5
781.3%
|
| Outpatient Week >8: minimally improved |
16.7
278.3%
|
14.3
204.3%
|
44.4
493.3%
|
28.6
408.6%
|
28.6
408.6%
|
28.6
408.6%
|
0.0
0%
|
37.5
468.8%
|
| Outpatient Week >8: no change |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.3
204.3%
|
0.0
0%
|
12.5
156.3%
|
0.0
0%
|
| Outpatient Week >8: minimally worse |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Suicidal behaviour | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 3/7 (42.9%) | 3/9 (33.3%) | 7/7 (100%) | 4/7 (57.1%) | 2/7 (28.6%) | 7/8 (87.5%) | 8/8 (100%) | ||||||||
| Eye disorders | ||||||||||||||||
| Vision blurred | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Ocular hyperaemia | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain upper | 0/6 (0%) | 1/7 (14.3%) | 2/9 (22.2%) | 2/7 (28.6%) | 2/7 (28.6%) | 0/7 (0%) | 0/8 (0%) | 2/8 (25%) | ||||||||
| Constipation | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Nausea | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 2/7 (28.6%) | 1/7 (14.3%) | 1/7 (14.3%) | 0/8 (0%) | 5/8 (62.5%) | ||||||||
| Vomiting | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 2/8 (25%) | ||||||||
| Diarrhoea | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||||||
| Faeces discoloured | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Application site irritation | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Asthenia | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Feeling jittery | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Infusion site extravasation | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Seasonal allergy | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Gastroenteritis viral | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Gastrointestinal viral infection | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Infectious mononucleosis | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Nasopharyngitis | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Intentional overdose | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Skin laceration | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Investigations | ||||||||||||||||
| Heart rate increased | 0/6 (0%) | 1/7 (14.3%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Decreased appetite | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Muscle spasms | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Dizziness | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Headache | 1/6 (16.7%) | 0/7 (0%) | 1/9 (11.1%) | 3/7 (42.9%) | 1/7 (14.3%) | 1/7 (14.3%) | 2/8 (25%) | 1/8 (12.5%) | ||||||||
| Somnolence | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 1/7 (14.3%) | 2/7 (28.6%) | 1/7 (14.3%) | 1/8 (12.5%) | 4/8 (50%) | ||||||||
| Nerve compression | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Affect lability | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Depression | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Insomnia | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 2/8 (25%) | 0/8 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Dysmenorrhoea | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Nasal congestion | 0/6 (0%) | 1/7 (14.3%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Oropharyngeal pain | 0/6 (0%) | 0/7 (0%) | 1/9 (11.1%) | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Sinus congestion | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Upper respiratory tract congestion | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Asthma | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||||||
| Epistaxis | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Blister | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Rash | 0/6 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | 1/7 (14.3%) | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00619619
Other Study ID Numbers:
- 3151A6-2000
- B2061012
- 3151A6-2000-US
First Posted:
Feb 21, 2008
Last Update Posted:
Feb 23, 2011
Last Verified:
Feb 1, 2011