CClinicalTrials.gg
Sign In
CompletedNCT00619619Updated Feb 23, 2011Results posted

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

A Phase 2 interventional study of Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) in Depression and Major Depressive Disorder, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 9 sites in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2011-02-23.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depression
  • Major Depressive Disorder

Keywords

  • MDD
  • Child
  • Adolescent
  • Pharmacokinetic
  • Outpatient
  • Pediatrics
  • Depressive Disorder
  • Major
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 59 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    A

    Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Interventions

  • DrugDesvenlafaxine 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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline to Follow-up (up to Day 77)

  2. Maximum Observed Plasma Concentration (Cmax)

    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

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    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

  4. Plasma Decay Half-Life (t1/2)

    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

  5. Area Under the Curve From Time Zero to Infinity (AUC0-∞)

    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

Secondary outcomes

  1. Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method

    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

  2. Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method

    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

Other outcomes

  1. Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score

    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)

  2. Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score

    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)

  3. Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit

    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)

  4. Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit

    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)

07

Results

Posted Feb 21, 2011

Participant flow

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).

Participant flow — Overall Study
MilestoneDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Started67977788
Entered the extension study65837667
Completed67865775
Not completed00112013
Withdrew: Physician decision00100000
Withdrew: Protocol violation00010011
Withdrew: Adverse event00002002

Outcome measures

Other pre-specifiedChange From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score

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)
Reported as:
Mean · scores on a scale
Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
scores on a scaleDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
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
Other pre-specifiedChange From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score

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)
Reported as:
Mean · Score on a scale
Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score
Score on a scaleDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
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
Other pre-specifiedPercentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit

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)
Reported as:
Number · percentage of participants
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit
percentage of participantsDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Inpatient Days 1 to 4: not ill at all0.00.00.00.00.00.00.00.0
Inpatient Days 1 to 4: borderline ill0.00.00.00.00.00.00.00.0
Inpatient Days 1 to 4: mildly ill0.00.00.014.30.00.00.012.5
Inpatient Days 1 to 4: moderately ill10010088.985.710010010087.5
Inpatient Days 1 to 4: markedly ill0.00.011.10.00.00.00.00.0
Outpatient Days 5 to 7: not ill at all0.00.00.00.00.00.00.00.0
Outpatient Days 5 to 7: borderline ill0.00.00.00.00.00.00.00.0
Outpatient Days 5 to 7: mildly ill0.042.944.40.00.014.30.012.5
Outpatient Days 5 to 7: moderately ill10057.155.610010085.710087.5
Outpatient Days 5 to 7: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 2: not ill at all0.00.00.00.00.00.00.00.0
Outpatient Week 2: borderline ill0.014.311.10.00.00.00.00.0
Outpatient Week 2: mildly ill66.757.155.60.00.028.65012.5
Outpatient Week 2: moderately ill33.328.633.310010071.45087.5
Outpatient Week 2: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 3: not ill at all0.00.00.00.00.00.00.00.0
Outpatient Week 3: borderline ill0.057.10.00.00.00.0250.0
Outpatient Week 3: mildly ill66.742.988.90.028.657.137.512.5
Outpatient Week 3: moderately ill33.30.011.110071.442.937.587.5
Outpatient Week 3: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 4: not ill at all0.014.30.00.00.00.00.00.0
Outpatient Week 4: borderline ill16.757.111.10.00.00.0500.0
Outpatient Week 4: mildly ill66.728.666.714.328.685.712.537.5
Outpatient Week 4: moderately ill16.70.022.285.771.414.337.562.5
Outpatient Week 4: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 5: not ill at all0.014.311.10.00.00.00.00.0
Outpatient Week 5: borderline ill16.757.111.10.00.00.0500.0
Outpatient Week 5: mildly ill66.728.655.614.328.685.712.537.5
Outpatient Week 5: moderately ill16.70.022.285.771.414.337.562.5
Outpatient Week 5: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 6: not ill at all0.00.011.10.00.00.00.00.0
Outpatient Week 6: borderline ill5057.111.10.00.014.362.50.0
Outpatient Week 6: mildly ill5042.966.728.657.157.112.550
Outpatient Week 6: moderately ill0.00.011.171.442.928.62550
Outpatient Week 6: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 7: not ill at all0.00.011.10.00.00.00.00.0
Outpatient Week 7: borderline ill5042.911.10.00.014.362.50.0
Outpatient Week 7: mildly ill5057.177.828.657.157.12550
Outpatient Week 7: moderately ill0.00.00.071.442.928.612.550
Outpatient Week 7: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week 8: not ill at all0.00.011.10.00.00.012.50.0
Outpatient Week 8: borderline ill66.742.922.20.00.028.6500.0
Outpatient Week 8: mildly ill33.357.166.771.457.171.42562.5
Outpatient Week 8: moderately ill0.00.00.028.642.90.012.537.5
Outpatient Week 8: markedly ill0.00.00.00.00.00.00.00.0
Outpatient Week >8: not ill at all0.00.011.10.00.00.012.50.0
Outpatient Week >8: borderline ill66.757.133.30.00.028.6500.0
Outpatient Week >8: mildly ill33.342.955.671.457.171.42562.5
Outpatient Week >8: moderately ill0.00.00.028.642.90.012.537.5
Outpatient Week >8: markedly ill0.00.00.00.00.00.00.00.0
PrimaryNumber of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)

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

Time frame:
Baseline to Follow-up (up to Day 77)
Reported as:
Number · participants
Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
participantsDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Serious Adverse Events00001000
Non-serious Adverse Events13374278
PrimaryMaximum Observed Plasma Concentration (Cmax)

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
Reported as:
Mean · ng/mL
Maximum Observed Plasma Concentration (Cmax)
ng/mLDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Maximum Observed Plasma Concentration (Cmax)33.9 ± 12.198 ± 60.5108 ± 27263 ± 6646.1 ± 15.993.9 ± 15.5202 ± 92449 ± 126
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax)

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
Reported as:
Mean · hr
Time to Reach Maximum Observed Plasma Concentration (Tmax)
hrDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Time to Reach Maximum Observed Plasma Concentration (Tmax)4.7 ± 2.14.3 ± 1.45.1 ± 35.0 ± 2.04.3 ± 0.78.7 ± 7.17.6 ± 3.47.5 ± 4.1
PrimaryPlasma Decay Half-Life (t1/2)

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
Reported as:
Mean · hr
Plasma Decay Half-Life (t1/2)
hrDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Plasma Decay Half-Life (t1/2)7.8 ± 1.48.6 ± 1.69.4 ± 2.79.0 ± 2.012 ± 310.2 ± 3.79.6 ± 2.09.8 ± 2.7
PrimaryArea Under the Curve From Time Zero to Infinity (AUC0-∞)

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
Reported as:
Mean · ng*hr/mL
Area Under the Curve From Time Zero to Infinity (AUC0-∞)
ng*hr/mLDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Area Under the Curve From Time Zero to Infinity (AUC0-∞)628 ± 3461704 ± 5532414 ± 9246732 ± 30311123 ± 3612281 ± 6895290 ± 218811730 ± 3113
SecondaryPopulation Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method

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
Reported as:
Number · (ng*hr/mL)/mg of dose

No measurements were reported for this outcome.

SecondaryPopulation Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method

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
Reported as:
Number · (ng*hr/mL)/mg of dose

No measurements were reported for this outcome.

Other pre-specifiedPercentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit

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)
Reported as:
Number · percentage of participants
Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit
percentage of participantsDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Inpatient Days 1 to 4: very much improved0.00.00.00.00.00.00.00.0
Inpatient Days 1 to 4: much improved0.00.00.014.314.30.00.012.5
Inpatient Days 1 to 4: minimally improved0.00.011.10.00.000.012.537.5
Inpatient Days 1 to 4: no change10010088.985.785.710087.550
Inpatient Days 1 to 4: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Days 5 to 7: very much improved0.00.00.00.00.00.00.00.0
Outpatient Days 5 to 7: much improved0.014.311.10.00.00.00.012.5
Outpatient Days 5 to 7: minimally improved5014.355.642.942.957.12525
Outpatient Days 5 to 7: no change5071.433.357.157.142.97562.5
Outpatient Days 5 to 7: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week 2: very much improved0.00.011.10.00.00.00.00.0
Outpatient Week 2: much improved33.328.644.414.30.00.00.025
Outpatient Week 2: minimally improved5042.911.142.942.957.17550
Outpatient Week 2: no change16.728.633.342.957.142.92525
Outpatient Week 2: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week 3: very much improved0.00.00.00.00.00.00.00.0
Outpatient Week 3: much improved5085.744.414.328.60.037.525
Outpatient Week 3: minimally improved5014.344.457.157.171.437.562.5
Outpatient Week 3: no change0.00.011.128.614.328.62512.5
Outpatient Week 3: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week 4: very much improved0.014.30.00.00.00.00.00.0
Outpatient Week 4: much improved5071.455.628.628.60.05037.5
Outpatient Week 4: minimally improved5014.322.257.157.185.737.537.5
Outpatient Week 4: no change0.00.011.114.314.314.312.512.5
Outpatient Week 4: minimally worse0.00.011.10.00.00.00.012.5
Outpatient Week 5: very much improved0.014.311.10.00.00.00.00.0
Outpatient Week 5: much improved5085.755.628.628.60.05037.5
Outpatient Week 5: minimally improved500.022.271.457.185.737.537.5
Outpatient Week 5: no change0.00.00.00.014.314.312.512.5
Outpatient Week 5: minimally worse0.00.011.10.00.00.00.012.5
Outpatient Week 6: very much improved0.014.311.10.00.00.00.00.0
Outpatient Week 6: much improved5057.166.728.657.171.47550
Outpatient Week 6: minimally improved5028.622.271.428.628.612.525
Outpatient Week 6: no change0.00.00.00.014.30.012.525
Outpatient Week 6: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week 7: very much improved0.014.311.10.00.00.00.00.0
Outpatient Week 7: much improved5042.955.628.657.171.47550
Outpatient Week 7: minimally improved5042.933.371.428.628.612.537.5
Outpatient Week 7: no change0.00.00.00.014.30.012.512.5
Outpatient Week 7: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week 8: very much improved0.014.322.20.00.00.012.50.0
Outpatient Week 8: much improved83.371.422.271.457.171.47562.5
Outpatient Week 8: minimally improved16.714.355.628.628.628.60.037.5
Outpatient Week 8: no change0.00.00.00.014.30.012.50.0
Outpatient Week 8: minimally worse0.00.00.00.00.00.00.00.0
Outpatient Week >8: very much improved0.014.322.20.00.00.012.50.0
Outpatient Week >8: much improved83.371.433.371.457.171.47562.5
Outpatient Week >8: minimally improved16.714.344.428.628.628.60.037.5
Outpatient Week >8: no change0.00.00.00.014.30.012.50.0
Outpatient Week >8: minimally worse0.00.00.00.00.00.00.00.0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Desvenlafaxine 10 mg Children—0/6 (0%)1/6 (16.7%)
Desvenlafaxine 25 mg Children—0/7 (0%)3/7 (42.9%)
Desvenlafaxine 50 mg Children—0/9 (0%)3/9 (33.3%)
Desvenlafaxine 100 mg Children—0/7 (0%)7/7 (100%)
Desvenlafaxine 25 mg Adolescent—1/7 (14.3%)4/7 (57.1%)
Desvenlafaxine 50 mg Adolescent—0/7 (0%)2/7 (28.6%)
Desvenlafaxine 100 mg Adolescent—0/8 (0%)7/8 (87.5%)
Desvenlafaxine 200 mg Adolescent—0/8 (0%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
Suicidal behaviourPsychiatric disorders0/60/70/90/71/70/70/80/8
Most frequent other events
Showing 10 of 40
Most frequent other events
EventDesvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg Adolescent
NauseaGastrointestinal disorders0/60/71/92/71/71/70/85/8
SomnolenceNervous system disorders0/60/71/91/72/71/71/84/8
HeadacheNervous system disorders1/60/71/93/71/71/72/81/8
Abdominal pain upperGastrointestinal disorders0/61/72/92/72/70/70/82/8
VomitingGastrointestinal disorders0/60/71/92/70/70/70/82/8
CoughRespiratory, thoracic and mediastinal disorders0/60/71/92/70/70/70/80/8
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/60/71/92/70/70/70/81/8
InsomniaPsychiatric disorders0/60/70/90/70/70/72/80/8
ConstipationGastrointestinal disorders0/60/70/91/70/70/70/80/8
Heart rate increasedInvestigations0/61/70/90/70/70/70/80/8

Baseline characteristics

Age Continuous
Age Continuous(years)Desvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg AdolescentTotal
Mean8.83 ± 1.339.57 ± 1.139.89 ± 1.279.71 ± 0.9515.00 ± 1.8313.14 ± 1.4614.25 ± 1.6714.00 ± 1.6011.86 ± 2.71
Sex: Female, Male
Sex: Female, Male(Participants)Desvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg AdolescentTotal
Female4334433529
Male2463345330
Children's Depression Ratings Scale-Revised (CDRS-R) total score
Children's Depression Ratings Scale-Revised (CDRS-R) total score(scores on a scale)Desvenlafaxine 10 mg ChildrenDesvenlafaxine 25 mg ChildrenDesvenlafaxine 50 mg ChildrenDesvenlafaxine 100 mg ChildrenDesvenlafaxine 25 mg AdolescentDesvenlafaxine 50 mg AdolescentDesvenlafaxine 100 mg AdolescentDesvenlafaxine 200 mg AdolescentTotal
Mean57.50 ± 4.8952.43 ± 5.1349.89 ± 7.3046.43 ± 4.3564.86 ± 11.8757.71 ± 1.9857.88 ± 9.1948.63 ± 6.2554.17 ± 8.78
08

Study locations

9 sites
  • Pfizer Investigational Site
    Little Rock, Arkansas 72205, United States
  • Pfizer Investigational Site
    North Miami, Florida 33161, United States
  • Pfizer Investigational Site
    Terre Haute, Indiana 47802, United States
  • Pfizer Investigational Site
    Wichita, Kansas 67211, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana 70114, United States
  • Pfizer Investigational Site
    New York, New York 10032, United States
  • Pfizer Investigational Site
    Cleveland, Ohio 44106-5080, United States
  • Pfizer Investigational Site
    Hershey, Pennsylvania 17033, United States
  • Pfizer Investigational Site
    Houston, Texas 77008, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00619619
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Feb 21, 2008
Start date
Feb 2008
Primary completion
Nov 2009
Completion
Nov 2009
Results posted
Feb 21, 2011
Last update
Feb 23, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression→

Other studies from this sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Start the discussion