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A randomized double-blind, placebo-controlled cross-over study was conducted using three doses (60, 100, and 150 mg) two formulations (oral (with 0.5 mg/kg phenelzine plus 10 mg chlorpheniramine) and transdermal patches over 4 days. Ninety patients with DSM-IV/TR-DSM-IV major depressive disorder and at least 6 months of follow-up received active treatment and 90 placebo. Clinical benefit was defined as the percentage of patients who achieved at least 50% reduction from baseline of the score on a Hamilton Rating Scale for Depression (HAM-D) scale, assessed at baseline and post-treatment. The mean percentage reduction from baseline of the HAM-D score was 59.0% (range, 0.6% to 74.0%) for the 60-mg and 64.9% (range, 25.7% to 96.9%) for the 150-mg and 60-mg patches, respectively. Clinical benefit was associated with efficacy as demonstrated by a marked improvement in the mean HAM-D score (P <.001) and an absence of placebo responses.
CONCLUSIONS:
Patients with major depressive disorder comorbid anxiety, psychotic
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