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

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00619619
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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