Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention description: 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.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: MDD; Child; Adolescent; Pharmacokinetic; Outpatient; Pediatrics; Depressive Disorder; Major

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.
    

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.