Sustained efficacy of gepirone-IR in major depressive disorder: a double-blind placebo substitution trial
| Autor: | Jay D. Amsterdam, Michael Gibertini, David J. Brunswick |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty Population Administration Oral Relapse prevention Placebo Severity of Illness Index law.invention Placebos Double-Blind Method Randomized controlled trial Recurrence law Internal medicine mental disorders Severity of illness medicine Humans Adverse effect education Biological Psychiatry Depressive Disorder education.field_of_study Dose-Response Relationship Drug Middle Aged Antidepressive Agents Discontinuation Psychiatry and Mental health Pyrimidines Treatment Outcome Tolerability Anesthesia Female Psychology |
| Zdroj: | Journal of Psychiatric Research. 38:259-265 |
| ISSN: | 0022-3956 |
| DOI: | 10.1016/j.jpsychires.2003.10.005 |
| Popis: | The objective of this paper is to evaluate the efficacy of gepirone immediate-release (gepirone-IR) for relapse prevention in outpatients with MDD who had responded to initial gepirone-IR therapy. Patients with MDD and a HAM-D(25) scoreor = 20 were treated with open-label gepirone-IR 20 to 90 mg/day for 6 weeks. Responders with a HAM-D(17) total scoreor = 12 or with aor = 50% reduction in total HAM-D(17) score and at least a "much improved" or "very much improved" CGI improvement score, were randomized to gepirone-IR or placebo for six additional weeks. Time to relapse was defined in six ways [(1) return toor = 75% of baseline HAM-D(17) total score; (2) CGI improvement score of "no change" or "minimally worse," "much worse" or "very much worse" than baseline (or = 4); and four more definitions combining the HAM-D(17) or CGI criteria with discontinuation, or discontinuation due to lack of efficacy] and analyzed for the ITT population using the LOCF method. Of 134 patients in the open-label phase, 70 were responders. In the double-blind phase, the relapse rate was significantly lower with gepirone-IR than with placebo (Por = 0.05) for four of the six definitions of relapse. Discontinuations of gepirone-IR due to adverse events were observed for 26.9% of patients in the open-label phase, and four patients (6%) during the double-blind phase. The most frequent adverse events with gepirone-IR were dizziness, nausea, headache, and somnolence, and with placebo were headache and paresthesia. A relapse-prevention study of longer duration is needed to confirm these preliminary results. Gepirone-IR was significantly more effective than placebo for relapse prevention and demonstrated acceptable tolerability in outpatient responders with MDD. |
| Databáze: | OpenAIRE |
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