Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: venlafaxine ER 75 mg/day (fixed dose); venlafaxine ER 75 mg/day to 225 mg/day (flexible dose); Placebo
Intervention description: Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration; Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration; Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 538.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: venlafaxine ER; Major depressive disorder; Japan; placebo-controlled

Summary:

      This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group
      study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and
      venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study
      consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The
      follow-up visit will be evaluated after 2 weeks of last study medication dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient status.

          -  A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode,
             without psychotic features.

          -  Depressive symptoms for at least 90 days in single episode and for at least 28 days in
             recurrent episode before the screening visit.

          -  A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS
             total score at baseline is not over 25% from the screening visit.

          -  A QIDS16-J-SR score ≥16 at the screening and baseline visits.

          -  A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening
             and baseline visits.

        Exclusion Criteria:

          -  Subjects who concurrently have Axis II personality disorder or mental retardation
             according to DSM-IV diagnostic criteria.

          -  Subjects who meet DSM-IV criteria for current or past history of Schizophrenia,
             Paranoid Disorders, or any other Psychotic Disorders.

          -  Subjects who meet DSM-IV criteria for current or past history of Dementia.

          -  Subjects who meet DSM-IV criteria for current or past history of bipolar disorder,
             Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).

          -  Subjects who meet DSM-IV criteria for current (within 12 months before the screening
             visit) generalized anxiety disorder, panic disorder, or social anxiety disorder
             considered by the investigator to be primary (causing a higher degree of distress or
             impairment than MDD).

          -  Subjects with a first degree relative with bipolar disorder.

          -  Subjects who are actively suicidal.

          -  History of non-responsive to 2 antidepressant treatment (at least 6-week usage for
             each) for the past or current episodes.

          -  History of Electroconvulsive therapy (ECT) at any time in the past.

          -  History of chronic treatment with benzodiazepines for longer than 6 months before the
             screening visit (Excluding subjects who have taken PRN benzodiazepine use, < 3
             times/week).

          -  Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
             hypertension), ophthalmologic, neurologic, or any other medical condition that in the
             investigator's judgment, will substantially increase the risk associated with the
             subject's participation in and completion of, the study.

          -  Known presence of raised intraocular pressure or history or presence of narrow angle
             glaucoma.

          -  Myocardial infarction within 180 days of the screening visit.

          -  Clinically important abnormalities, as determined by the investigator, on screening
             physical examination, electrocardiogram (ECG) or laboratory tests.

          -  Use of prohibited treatments