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

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ClinicalTrials.gov Identifier: NCT00619619
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : February 21, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 28, 2008
First Posted Date  ICMJE February 21, 2008
Results First Submitted Date  ICMJE November 10, 2010
Results First Posted Date  ICMJE February 21, 2011
Last Update Posted Date February 23, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
  • Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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) [ 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 ]
    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) [ 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 ]
    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) [ 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 ]
    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-∞) [ 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 ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2008)
Safety, Tolerability, and PK [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
  • Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method [ Time Frame: 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 [ Time Frame: 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].
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2008)
Population PK and Efficacy [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2011)
  • Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Depression
  • Major Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: A
Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2011)
59
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2008)
48
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00619619
Other Study ID Numbers  ICMJE 3151A6-2000
B2061012
3151A6-2000-US
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP