Phase 2 Completed N=59 Randomized

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

Source: ClinicalTrials.gov NCT00619619 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Feb 2011

Primary outcomePrimary: Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) — 0; 0; 0; 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)	0; 0; 0; 0; 1; 0	—
PRIMARY Maximum Observed Plasma Concentration (Cmax)	33.9; 98; 108; 263; 46.1; 93.9	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax)	4.7; 4.3; 5.1; 5.0; 4.3; 8.7	—
PRIMARY Plasma Decay Half-Life (t1/2)	7.8; 8.6; 9.4; 9.0; 12; 10.2	—
PRIMARY Area Under the Curve From Time Zero to Infinity (AUC0-∞)	628; 1704; 2414; 6732; 1123; 2281	—
SECONDARY Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method	—	—
SECONDARY Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method	—	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00619619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.