Abstract | BACKGROUND: METHOD: 365 outpatients 18 to 65 years old with a DSM-IV diagnosis of major depressive disorder were enrolled at 16 sites. A 17-item Hamilton Rating Scale for Depression (HAM-D-17) score of > or = 20 was required for entry. Patients were randomly assigned to receive either STS, 20 mg/20 cm(2), daily or placebo patch for up to 8 weeks. A tyramine-restricted diet was neither required nor advised. Efficacy, safety, and vital sign measures were obtained regularly. RESULTS: 289 patients were randomly assigned to treatment and received at least 1 on- therapy evaluation (STS, N = 145; placebo, N = 144). Although the effect size was modest, at endpoint, STS was statistically superior to placebo on the MADRS (p =.001) and HAM-D-28 (p =.039) ratings and showed a nonsignificant superiority on the HAM-D-17 (p =.069) and Clinical Global Impressions-Severity ratings (p <.055). Side effect profiles were similar for STS and placebo with the exception of application-site reaction, which was observed in 31.5% of STS patients and 15.1% of placebo-treated patients (p =.001). No significant differences were observed in blood pressure measures between treatment groups. CONCLUSION: Results from this double-blind, placebo-controlled clinical trial demonstrate that STS may have a modest, but statistically significant, antidepressant benefit compared with placebo and a similar safety profile compared with placebo in the absence of a tyramine-restricted diet.
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Authors | Jay D Amsterdam |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 64
Issue 2
Pg. 208-14
(Feb 2003)
ISSN: 0160-6689 [Print] United States |
PMID | 12633131
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Monoamine Oxidase Inhibitors
- Placebos
- Selegiline
- Tyramine
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Topics |
- Administration, Cutaneous
- Adult
- Aged
- Ambulatory Care
- Depressive Disorder
(diagnosis, drug therapy)
- Diet
(methods)
- Double-Blind Method
- Female
- Humans
- Hypertension
(chemically induced, prevention & control)
- Male
- Middle Aged
- Monoamine Oxidase Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Placebos
- Psychiatric Status Rating Scales
- Selegiline
(administration & dosage, adverse effects, therapeutic use)
- Treatment Outcome
- Tyramine
(adverse effects, metabolism)
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