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
Overview
- Phase
- Phase 2
- Intervention
- Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
- Conditions
- Depression
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
A
Intervention: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method(Day 1, Day 28, and Day 56)
- Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method(Day 1, Day 28, and Day 56)