Prozac Treatment of Major Depression: Discontinuation Study
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study randomized two stratifications of acute phase MDD SSRI responders, categorized as
      having either "true drug" response or "placebo response" pattern, to continuation with SSRI
      vs placebo in a double-blind trial to determine if stratification category predicted
      continuation outcome.
    

Detailed description: 
      This study enrolled 627 subjects with Major Depressive illness at New York State Psychiatric
      Institute and Massachusetts General Hospital. Subjects were treated with fluoxetine 10-60mg
      over a 12 week period. The "responder" group was defined by those no longer meeting criteria
      for Major Depression at week 12, along with CGI ratings of "much improved" or "very much
      improved" as determined by an independent evaluator. At week 12 "non-responders" were
      withdrawn from the study and received open label treatment; responders were randomized in
      double-blind fashion to either fluoxetine continuation (20-80mg daily) at response dose or
      placebo switch for up to 24 weeks. The responder group was stratified by "specific or true"
      drug response (late onset and persistent once attained) and "nonspecific or placebo" response
      (early onset or nonpersistent) patterns. Subjects were evaluated at one week and two week
      intervals at different phases of continuation treatment, and depression relapse was
      determined by agreement between study psychiatrist and independent evaluator CGI and Ham-D
      ratings, as well as administration of the MDD section of the Mood Disorders Module of the
      Structured Clinical Interview for DSM-IV Disorders at those visits. A subset of study
      participants also provided DNA samples to determine whether there are any DNA markers of
      response type. Data were analyzed to test the following hypotheses: that during continuation
      fluoxetine treatment improved patients with a "true drug" acute response pattern randomized
      to placebo had a poorer outcome than those maintained on active drug; that during
      continuation fluoxetine treatment improved patients with a "placebo" acute response pattern
      randomized to placebo had no worse an outcome than those maintained on drug; that during
      continuation fluoxetine treatment patients with a "true drug" acute response pattern
      randomized to continue on fluoxetine were more likely to maintain their benefit than those
      with a "placebo" pattern.
    

Intervention name(s): fluoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg/day increased over 12 weeks to 20-80 mg/day; 20-80 mg/day maintained from week 13-36.; Week 13-36.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depression; "true drug" response; "placebo response" pattern; continuation treatment outcomes