A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

• Drug: sertraline/[S,S]-reboxetine
  
  Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: sertraline/[S,S]-reboxetine
  
  Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: sertraline
  
  Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
• Drug: sertraline
  
  Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
• Drug: sertraline/[S,S]-reboxetine
  
  Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
• Drug: Placebo
  
  Tablets, orally once per day for 8 weeks
• Drug: sertraline/[S,S]-reboxetine
  
  Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
• Drug: [S,S]-reboxetine monotherapy
  
  Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks

• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/4
  
  Intervention: Drug: sertraline/[S,S]-reboxetine
• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/6
  
  Intervention: Drug: sertraline/[S,S]-reboxetine
• Active Comparator: sertraline-satellite
  
  Intervention: Drug: sertraline
• Active Comparator: sertraline-main
  
  Intervention: Drug: sertraline
• Experimental: Sertraline/[S,S]-Reboxetine-satellite150/2
  
  Intervention: Drug: sertraline/[S,S]-reboxetine
• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo
• Experimental: Sertraline/[S,S]-Reboxetine-main
  
  Intervention: Drug: sertraline/[S,S]-reboxetine
• Active Comparator: [S,S]-reboxetine-main
  
  Intervention: Drug: [S,S]-reboxetine monotherapy

Inclusion Criteria:

• Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
• HAM-D (17-item) ? 22 at Screening (Visit 1) and > 20 at Baseline (Visit 2).
• Minimum CGI-S ? 4 at Screening (Visit 1) and at Baseline (Visit 2).

Exclusion Criteria:

• Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
• Subjects with > 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
• Subjects with uncorrected hypothyroidism or hyperthyroidism.