A randomized double-blind fluvoxamine/placebo crossover trial in pathologic gambling
A randomized double-blind fluvoxamine/placebo crossover trial in pathologic gambling
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DOI：
10.1016/s0006-3223(00)00241-9
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发表时间：
2000-05-01
影响因子：
10.6
通讯作者：
Cartwright, C
中科院分区：
文献类型：
--
作者：
Hollander, E;DeCaria, CM;Cartwright, C
背景：本研究评估了选择性5-羟色胺再摄取抑制剂(SSRI)氟伏沙明治疗病理性赌博(PG)的有效性和耐受性。方法：采用16周随机双盲交叉设计，确保每个受试者分别服用8周的氟伏沙明和8周的安慰剂。结果：在PG临床总体印象量表(PG-CGI)上，氟伏沙明显著改善了整体赌博严重程度。通过对Yale-Brown强迫量表和PG-CGI量表改进得分的PG修改，发现药物对赌博冲动和行为有显著的影响，但药物效应与给药顺序和安慰剂的给药顺序存在显著的交互作用。将每个阶段作为一个单独的试验进行的事后分析表明，在试验的第二阶段，氟伏沙明和安慰剂之间有显著差异，但在第一阶段没有显著差异。氟伏沙明的副作用只有轻微的强度，与SSRI治疗一致，与早期退出研究无关。结论：这些发现表明，氟伏沙明耐受性良好，在急性试验中可能有效治疗PG，PG治疗的早期安慰剂效应似乎随着时间的推移而减弱。为了证实这一发现，并确定改善是否在较长时间内持续，应在更大和更多样化的PG人群中进行持续时间更长、长期维持随访的平行设计试验。生物精神病学2000；47：813-817(C)2000生物精神病学学会。
Background: The study assessed the efficacy and tolerability of the selective serotonin reuptake inhibitor (SSRI) fluvoxamine in the treatment of pathologic gambling (PG).Methods: A 16-week randomized double-blind crossover design insured that each subject received 8 weeks of fluvoxamine and 8 weeks of a placebo. Fifteen patients entered and 10 subjects, all male, completed the study.Results: Fluvoxamine resulted in a significantly greater percent improvement in overall gambling severity on the PG Clinical Global Impression (PG-CGI) scale. There was a significant drug effect on gambling urge and behavior as measured by the PG modification of the Yale-Brown Obsessive Compulsive Scale and PG-CGI scale improvement scores; however, there was a significant interaction of drug effect with the order of administration of drug and placebo. Post hoc analysis, treating each phase as a separate trial, demonstrated a significant difference between fluvoxamine and the placebo in the second phase of the trial but not in the first. Fluvoxamine side effects were of only mild intensity and consistent with SSRI treatment and were not associated with early withdrawal from the study.Conclusions: These findings suggest that fluvoxamine is well tolerated and may be effective in the treatment of PG in an acute trial, and that an early placebo effect in PG treatment appears to diminish over time. To confirm this finding and to determine whether improvement persists over an extended period of time, a longer duration parallel-design trial with long-term maintenance follow-up should be conducted in a larger and more diverse PG population. Biol Psychiatry 2000;47:813-817 (C) 2000 Society of Biological Psychiatry.