Pilot efficacy trial of abt-200 in patients with major depressive disorder

Autor: Carrie Sadd, Ken Kashkin, John J. Sramek, Sara Kennedy, Olga Jasinsky, Vincent Shu, Neal R. Cutler, Stephen Chang
Rok vydání: 1994
Předmět:
Zdroj: Depression. 2:315-318
ISSN: 1522-7162
1062-6417
Popis: ABT-200 is a novel potential antidepressant which antagonizes both norepi-nephrine uptake and noradrenergic alpha-2 receptors. Patients who met DSM-III-R criteria for major depressive disorder and continued to meet all inclusion criteria following a 1-week placebo lead-in were randomized to receive ABT-200 (n = 46) or placebo (n = 45) for 8 weeks. During the first 3 weeks of the study, the ABT-200 dosage was titrated from 60 mg/day (Week 1), to 100 mg/day (Week 2), to 140 mg/day (Week 3), as tolerated. Treatment group differences in total HAM-D change from baseline to end of Week 8 were not significantly different (−7.2 points or 26% decrease on ABT-200 vs. -6.9 points or 23% decrease on placebo, P = 0.880). Similarly, no significant effects were seen on the MADRS or CGI scales. However, HAM-D core depression items were significantly decreased with ABT-200 compared with placebo at the end of treatment (−2.3 points or 29% decrease on drug vs. -1.1 points or 14% decrease with placebo, P = 0.038). The overall incidence of adverse events reported with ABT-200 and placebo was similar. Insomnia, however, occurred at a significantly greater incidence rate with ABT-200 compared to placebo (22% vs. 4%, P = 0.027). Thus, ABT-200 was well tolerated but did not demonstrate overall antidepressant efficacy. Depression 2:315–318 (1994/1995). © 1995 Wiley-Liss, Inc.
Databáze: OpenAIRE
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