Section of Cognitive Neuropsychiatry, Institute of Psychiatry, King's College, London, UK.
Neuropsychiatr Dis Treat. 2009;5:327-32. doi: 10.2147/ndt.s5335. Epub 2009 Jun 10.
Psychosis (delusions and/or hallucinations) is a well-recognized complication of treatment of Parkinson's disease (PD). Quetiapine is a currently favored treatment, but data on its efficacy are equivocal. This trial aimed to provide further evidence on the efficacy of quetiapine in PD psychosis.
We conducted a 12 week double blind randomized placebo-controlled trial. Time to dropout due to lack of improvement of psychosis was the primary outcome measure. Other important secondary outcomes were evaluated using standard rating scales for PD and psychiatric symptoms.
Twenty-four eligible subjects gave consent. The primary outcome, time to dropout, was examined using survival analysis. It was shown that patients in the quetiapine group dropped out earlier than those in the placebo group, but this difference was not significant (p = 0.68). No significant changes were found for any of the secondary outcome measures in either group.
In this study, quetiapine at doses of up to 150 mg/day failed to significantly improve psychosis compared to placebo, however the small sample size does not allow any conclusive interpretation of the results. Quetiapine did not appear to worsen PD motor functioning, but its use was limited by a faster drop out compared with placebo. Significant impediments were difficulty with recruitment and natural fluctuation in symptoms during the trial.
精神症状(妄想和/或幻觉)是帕金森病(PD)治疗中一种公认的并发症。喹硫平是目前常用的治疗药物,但关于其疗效的数据尚无定论。本试验旨在为喹硫平治疗 PD 精神症状的疗效提供进一步的证据。
我们进行了一项为期 12 周的双盲随机安慰剂对照试验。因精神症状无改善而退出试验的时间是主要的结局测量指标。使用 PD 和精神症状的标准评定量表评估其他重要的次要结局。
24 名符合条件的受试者同意参加。使用生存分析检查主要结局,即退出时间。结果显示,喹硫平组的患者比安慰剂组更早退出,但差异无统计学意义(p = 0.68)。两组在任何次要结局测量指标上均未发现显著变化。
在这项研究中,与安慰剂相比,高达 150mg/天的喹硫平并不能显著改善精神症状,但小样本量不允许对结果进行任何结论性解释。喹硫平似乎没有使 PD 的运动功能恶化,但与安慰剂相比,它更快地导致患者退出治疗。招募困难和试验期间症状的自然波动是显著的障碍。