- 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.
- 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
- 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.