Department of Neurology and Psychiatry, School of Medicine, Arak University of Medical Sciences, Arak.
Department of Neurology, School of Medicine, Arak University of Medical Sciences, Arak.
Int Clin Psychopharmacol. 2019 Sep;34(5):222-233. doi: 10.1097/YIC.0000000000000267.
This study aimed to assess the efficacy and tolerability of ondansetron vs. granisetron in patients with treatment-resistant obsessive-compulsive disorder. A randomized clinical trial conducted on 135 patients with a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of obsessive-compulsive disorder, who were treatment-resistant and receiving stable treatment with selective serotonin reuptake inhibitors and antipsychotic, received 14 weeks (phase I, intervention period) of placebo (n = 45), ondansetron (n = 45, 4 mg), and granisetron (n = 45, 2 mg) daily augmentations. Patients were rated every 2 weeks using the Yale-Brown Obsessive Compulsive Scale. Upon completion of intervention course, patients were followed for 4 weeks (phase II, discontinuation period). The collected data were analyzed in SPSS Version 22, with χ test; Fisher's exact test and independent t-test, according to the intention-to-treat principle. Two-factor repeated measure analysis of variance was used to compare score changes over phases. P < 0.05 was considered to be statistically significant. At week 14, reduction in Yale-Brown Obsessive Compulsive Scale scores in ondansetron, granisetron and placebo groups was 41.5%, 39.7% and 15.2%, respectively (P = 0.001). Complete response in the ondansetron group was significantly higher than in the granisetron group ((P = 0.041), risk ratio (95% confidence interval) = 2.33 (1.18-3.045)]. Relapse occurred by three (7.31%) patients in the granisetron group, whereas it was not seen in the ondansetron group [P < 0.001, risk ratio (95% confidence interval) = 2.81 (1.016-4.51)]. The results of this present study confirm the benefit of using ondansetron and granisetron as augmenting agents in treatment-resistant obsessive-compulsive disorder. Our results supported the potential superiority of ondansetron compared to granisetron. This needs to be confirmed in further placebo-controlled augmentation studies. RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL REGISTRATION NUMBER:: IRCT20130726014170N2.
本研究旨在评估昂丹司琼与格拉司琼治疗抵抗性强迫症患者的疗效和耐受性。对 135 例符合《精神障碍诊断与统计手册》第 4 版（DSM-IV）强迫症诊断、治疗抵抗且正在接受选择性 5-羟色胺再摄取抑制剂和抗精神病药物稳定治疗的患者进行了一项随机临床试验，这些患者接受了为期 14 周的（第 I 阶段，干预期）安慰剂（n=45）、昂丹司琼（n=45，4mg）和格拉司琼（n=45，2mg）每日增效治疗。每 2 周对患者进行一次耶鲁-布朗强迫症量表评估。干预疗程结束后，患者进行了 4 周的随访（第 II 阶段，停药期）。采用 SPSS 版本 22 进行数据分析，采用 χ2 检验；Fisher 确切检验和独立 t 检验，根据意向治疗原则。采用双因素重复测量方差分析比较各阶段评分变化。P＜0.05 为统计学意义显著。第 14 周时，昂丹司琼、格拉司琼和安慰剂组的耶鲁-布朗强迫症量表评分分别降低了 41.5%、39.7%和 15.2%（P=0.001）。昂丹司琼组的完全缓解率明显高于格拉司琼组（（P=0.041），风险比（95%置信区间）=2.33（1.18-3.045）]。格拉司琼组有 3 例（7.31%）患者复发，而昂丹司琼组未见复发[P＜0.001，风险比（95%置信区间）=2.81（1.016-4.51）]。本研究结果证实了昂丹司琼和格拉司琼作为增效剂在治疗抵抗性强迫症中的益处。我们的结果支持昂丹司琼相对于格拉司琼可能具有优势。这需要在进一步的安慰剂对照增效研究中得到证实。随机对照临床试验注册号：IRCT20130726014170N2。
