Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine succinate sustained release 50 mg; Desvenlafaxine succinate sustained release 25 mg; Placebo
Intervention description: 50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.; 25 mg tablet for taper, once daily for 1 week; Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 874.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      The primary purpose of this study is to compare the long-term efficacy and safety of
      desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive
      Disorder, using a randomized withdrawal design. Randomized withdrawal means that after
      receiving desvenlafaxine succinate sustained release for a predetermined period of time,
      subjects will be selected by chance to either continue receiving the study drug or to be
      withdrawn from the study drug and receive placebo for the remainder of their participation in
      the trial. Subjects will not know to which group they have been assigned.

      The study consists of an up to 14-day screening period followed by an 8-week open-label
      period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate
      sustained release. Subjects who do not respond to treatment, demonstrating no significant
      change in their depressive symptoms, will be withdrawn from participation at the end of this
      period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine
      succinate sustained release at the same dose. Subjects with stable response to treatment at
      the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate
      sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or
      until symptoms of depression return. Following discontinuation at any point after enrollment
      in the study, subjects will receive two weeks of follow-up monitoring, including one week of
      blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any
      subjects who have been taking desvenlafaxine succinate sustained release prior to
      discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following
      taper, subjects will be evaluated for one additional week to monitor safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
             symptoms for at least 30 days prior to screening)

          -  Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20

          -  Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

        Exclusion Criteria:

          -  Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia
             Suicide-Severity Rating Scale scores.

          -  Past treatment with desvenlafaxine succinate sustained release.

          -  Other eligibility criteria also apply.