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拉莫三嗪增效疗法与安慰剂治疗5-羟色胺再摄取抑制剂抵抗的强迫症的随机对照试验

Lamotrigine Augmentation Versus Placebo in Serotonin Reuptake Inhibitors-Resistant Obsessive-Compulsive Disorder: A Randomized Controlled Trial.

作者信息

Khalkhali Mohammadrasoul, Aram Setareh, Zarrabi Homa, Kafie Moosa, Heidarzadeh Abtin

机构信息

Department of Psychiatry, Guilan University of Medical Sciences, Rasht, Iran. Email:

Department of Psychology, Guilan University, Rasht, Iran. Email:

出版信息

Iran J Psychiatry. 2016 Apr;11(2):104-14.

PMID:27437007
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4947218/
Abstract

OBJECTIVE

Serotonin reuptake inhibitors are frequently used in first-line treatments for patients with obsessive-compulsive disorder. Nevertheless, many of these patients do not respond well to initial therapy. The hypothesis of glutamatergic dysfunction in specific brain regions has been proposed in the pathophysiology of obsessive-compulsive disorder. This study was designed to evaluate the possible efficacy of lamotrigine, a glutamatergic agent in Serotonin reuptake inhibitors-resistant patients with obsessive-compulsive disorder.

METHOD

This study was a 12-week, double blind, randomized, placebo-controlled trial of adjunctive fixed-doses of lamotrigine (100 mg) to Serotonin reuptake inhibitors therapy in obsessive-compulsive disorder. Eligible subjects who had a total Y-BOCS of 21 or above were randomly assigned to receive adjunctive treatment with either lamotrigine (n = 26), or placebo (n = 27). Response to lamotrigine was defined as clinical improvement (>25% decrease in the total Y-BOCS score), which was administered at weeks 0, 8 and 12.

RESULTS

At the endpoint (week 12), significant differences were observed in obsession, compulsion, and total Y-BOCS scores comparing lamotrigine to placebo (P = 0.01, 0.005 and 0.007 respectively). The mean reduction in obsession, compulsion and total scores in lamotrigine group was about 4.15, 4.50 and 8.73, respectively. Similarly, the mean reductions in the placebo group were 2.52, 2.56 and 5.07. Effect sizes for efficacy measureswerecalculatedbyCohen'sd, and it was calculated as 0.54 for the total YBOCS.

CONCLUSION

Our findings provide evidence that this augmentation is well tolerated and may be an effective strategy for patients with refractory obsessive-compulsive disorder.

摘要

目的

5-羟色胺再摄取抑制剂常用于强迫症患者的一线治疗。然而,许多此类患者对初始治疗反应不佳。在强迫症的病理生理学中,已提出特定脑区谷氨酸能功能障碍的假说。本研究旨在评估拉莫三嗪(一种谷氨酸能药物)对5-羟色胺再摄取抑制剂耐药的强迫症患者的可能疗效。

方法

本研究是一项为期12周的双盲、随机、安慰剂对照试验,在强迫症患者中,对5-羟色胺再摄取抑制剂治疗辅助固定剂量(100毫克)的拉莫三嗪。总耶鲁布朗强迫症量表(Y-BOCS)得分在21分及以上的符合条件的受试者被随机分配接受拉莫三嗪(n = 26)或安慰剂(n = 27)的辅助治疗。对拉莫三嗪的反应定义为临床改善(Y-BOCS总分降低>25%),在第0、8和12周进行评估。

结果

在终点(第12周),与安慰剂相比,拉莫三嗪在强迫观念、强迫行为和Y-BOCS总分上有显著差异(分别为P = 0.01、0.005和0.007)。拉莫三嗪组强迫观念、强迫行为和总分的平均降低分别约为4.15、4.50和8.73。同样,安慰剂组的平均降低分别为2.52、2.56和5.07。疗效测量的效应大小通过科恩d值计算,总Y-BOCS的效应大小计算为0.54。

结论

我们的研究结果提供了证据,表明这种增效治疗耐受性良好,可能是难治性强迫症患者的一种有效策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/39612d983878/IJPS-11-104-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/b98a9c944571/IJPS-11-104-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/1dbc2e47095b/IJPS-11-104-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/4e57944d10dd/IJPS-11-104-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/39612d983878/IJPS-11-104-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/b98a9c944571/IJPS-11-104-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/1dbc2e47095b/IJPS-11-104-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/4e57944d10dd/IJPS-11-104-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ad8/4947218/39612d983878/IJPS-11-104-g003.jpg

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