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A double-blind trial of low- and high-dose ranges of gepirone-ER compared with placebo in the treatment of depressed outpatients.
Wilcox, C S; Ferguson, J M; Dale, J L; Heiser, J F.
Afiliação
  • Wilcox CS; Pharmacology Research Institute, Long Beach, CA 90807-3947, USA.
Psychopharmacol Bull ; 32(3): 335-42, 1996.
Article em En | MEDLINE | ID: mdl-8961776
ABSTRACT
We report the results of a double-blind study comparing the efficacy and safety of low-dose (10-50 mg) and high-dose (20-100 mg) ranges of gepirone-extended release (ER) and placebo in 145 outpatients with major depressive disorder. At multiple time points and endpoint (Week 6), statistically significant reductions in Hamilton Rating Scale for Depression (HAM-D) scores were recorded for high-dose gepirone-ER compared to placebo. Analysis of the 17-item HAM-D and 28-item HAM-D scores indicated a relatively early onset of antidepressant efficacy with statistically significant results at treatment Weeks 1, 2, 4, and 6. A rapid response was evident in the high-dose group, beginning at Week 1 (p < .05). The most frequently reported adverse experiences were headache, nausea, dizziness, and insomnia. The results indicate that gepirone-ER is clearly superior to placebo in terms of antidepressant efficacy. When used at higher doses, gepirone-ER appears to be efficacious, safe, and well-tolerated in depressed out-patients.
Assuntos
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Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Pirimidinas / Transtorno Depressivo / Antidepressivos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Psychopharmacol Bull Ano de publicação: 1996 Tipo de documento: Article
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Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Pirimidinas / Transtorno Depressivo / Antidepressivos Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Psychopharmacol Bull Ano de publicação: 1996 Tipo de documento: Article