- 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).
- 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.