{"title":"萘普生辅助氟西汀治疗中重度强迫症:随机、双盲、安慰剂对照试验。","authors":"Ahmad Shamabadi, Zahra Motavalian, Yalda Farahmand, Kimia Farahmand, Razman Arabzadeh Bahri, Sanaz Askari, Sahar Ansari, Mohammadali Fallahzadeh, Mohammdreza Shalbafan, Shahin Akhondzadeh","doi":"10.1111/pcn.13748","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>Current treatments for obsessive-compulsive disorder (OCD) encounter resistance and limiting adverse events, necessitating novel therapeutic strategies. This study aimed to investigate the benefits of naproxen, a medication with effects on inflammation and neuronal function, on OCD.</p><p><strong>Methods: </strong>One hundred and four OCD outpatients with a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >21 were equally assigned to receive fluoxetine plus either naproxen 250 mg or matched placebo q12hr. Patients were assessed using the Y-BOCS by recording the subscale scores at baseline and weeks 5 and 10 to evaluate efficacy. They were also assessed in terms of tolerability.</p><p><strong>Results: </strong>Data from 96 patients were analyzed. The baseline characteristics were comparable between the groups. There were significant time-treatment interaction effects on the obsession subscale ( <math> <mrow><msubsup><mi>η</mi> <mi>P</mi> <mn>2</mn></msubsup> </mrow> </math> = 0.055) and total ( <math> <mrow><msubsup><mi>η</mi> <mi>P</mi> <mn>2</mn></msubsup> </mrow> </math> = 0.043) scores of Y-BOCS. Reductions in the obsession subscale and total scores of Y-BOCS were significantly greater in the fluoxetine plus naproxen group until the endpoint (Cohen's d = 0.560 and Cohen's d = 0.477, respectively). However, the difference in compulsion subscale score changes between the groups was not significant. Respondents with a reduction of ≥35% in Y-BOCS total scores were significantly more in the fluoxetine plus naproxen group (80.0% versus 47.8%). The side effect frequencies were comparable between the groups.</p><p><strong>Conclusion: </strong>Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe and tolerable manner.</p><p><strong>Clinical trial registration: </strong>The study protocol was registered and published in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number IRCT20090117001556N139).</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":"810-817"},"PeriodicalIF":5.0000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Naproxen adjunct to fluoxetine for moderate-to-severe obsessive-compulsive disorder: A randomized, double-blind, placebo-controlled trial.\",\"authors\":\"Ahmad Shamabadi, Zahra Motavalian, Yalda Farahmand, Kimia Farahmand, Razman Arabzadeh Bahri, Sanaz Askari, Sahar Ansari, Mohammadali Fallahzadeh, Mohammdreza Shalbafan, Shahin Akhondzadeh\",\"doi\":\"10.1111/pcn.13748\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>Current treatments for obsessive-compulsive disorder (OCD) encounter resistance and limiting adverse events, necessitating novel therapeutic strategies. This study aimed to investigate the benefits of naproxen, a medication with effects on inflammation and neuronal function, on OCD.</p><p><strong>Methods: </strong>One hundred and four OCD outpatients with a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >21 were equally assigned to receive fluoxetine plus either naproxen 250 mg or matched placebo q12hr. Patients were assessed using the Y-BOCS by recording the subscale scores at baseline and weeks 5 and 10 to evaluate efficacy. They were also assessed in terms of tolerability.</p><p><strong>Results: </strong>Data from 96 patients were analyzed. The baseline characteristics were comparable between the groups. There were significant time-treatment interaction effects on the obsession subscale ( <math> <mrow><msubsup><mi>η</mi> <mi>P</mi> <mn>2</mn></msubsup> </mrow> </math> = 0.055) and total ( <math> <mrow><msubsup><mi>η</mi> <mi>P</mi> <mn>2</mn></msubsup> </mrow> </math> = 0.043) scores of Y-BOCS. Reductions in the obsession subscale and total scores of Y-BOCS were significantly greater in the fluoxetine plus naproxen group until the endpoint (Cohen's d = 0.560 and Cohen's d = 0.477, respectively). However, the difference in compulsion subscale score changes between the groups was not significant. Respondents with a reduction of ≥35% in Y-BOCS total scores were significantly more in the fluoxetine plus naproxen group (80.0% versus 47.8%). The side effect frequencies were comparable between the groups.</p><p><strong>Conclusion: </strong>Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe and tolerable manner.</p><p><strong>Clinical trial registration: </strong>The study protocol was registered and published in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number IRCT20090117001556N139).</p>\",\"PeriodicalId\":20938,\"journal\":{\"name\":\"Psychiatry and Clinical Neurosciences\",\"volume\":\" \",\"pages\":\"810-817\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Psychiatry and Clinical Neurosciences\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/pcn.13748\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychiatry and Clinical Neurosciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pcn.13748","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:目前治疗强迫症(OCD)的方法存在抗药性和限制性不良反应,因此需要新的治疗策略。本研究旨在探讨萘普生这种对炎症和神经元功能有影响的药物对强迫症的益处:方法:将耶鲁-布朗强迫症量表(Y-BOCS)评分大于21分的144名强迫症门诊患者平均分配到接受氟西汀加萘普生250毫克或相匹配的安慰剂治疗,每12小时一次。 在基线和第5、10周时使用Y-BOCS对患者进行评估,记录分量表评分,以评估疗效。此外,还对患者的耐受性进行了评估:结果:分析了 96 名患者的数据。两组患者的基线特征相当。Y-BOCS的强迫分量表(η P 2 $$ {\eta}_P^2 $$ = 0.055)和总分(η P 2 $$ {\eta}_P^2 $$ = 0.043)存在明显的时间-治疗交互效应。直到终点,氟西汀加萘普生组强迫分量表和Y-BOCS总分的降低幅度明显更大(分别为Cohen's d = 0.560和Cohen's d = 0.477)。然而,两组间强迫量表分值的变化差异并不显著。Y-BOCS总分降低≥35%的受访者在氟西汀加萘普生组明显更多(80.0%对47.8%)。两组的副作用频率相当:临床试验注册:研究方案已在伊朗临床试验注册中心(http://www.irct.ir;注册号为 IRCT20090117001556N139)注册并公布。
Naproxen adjunct to fluoxetine for moderate-to-severe obsessive-compulsive disorder: A randomized, double-blind, placebo-controlled trial.
Aim: Current treatments for obsessive-compulsive disorder (OCD) encounter resistance and limiting adverse events, necessitating novel therapeutic strategies. This study aimed to investigate the benefits of naproxen, a medication with effects on inflammation and neuronal function, on OCD.
Methods: One hundred and four OCD outpatients with a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >21 were equally assigned to receive fluoxetine plus either naproxen 250 mg or matched placebo q12hr. Patients were assessed using the Y-BOCS by recording the subscale scores at baseline and weeks 5 and 10 to evaluate efficacy. They were also assessed in terms of tolerability.
Results: Data from 96 patients were analyzed. The baseline characteristics were comparable between the groups. There were significant time-treatment interaction effects on the obsession subscale ( = 0.055) and total ( = 0.043) scores of Y-BOCS. Reductions in the obsession subscale and total scores of Y-BOCS were significantly greater in the fluoxetine plus naproxen group until the endpoint (Cohen's d = 0.560 and Cohen's d = 0.477, respectively). However, the difference in compulsion subscale score changes between the groups was not significant. Respondents with a reduction of ≥35% in Y-BOCS total scores were significantly more in the fluoxetine plus naproxen group (80.0% versus 47.8%). The side effect frequencies were comparable between the groups.
Conclusion: Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe and tolerable manner.
Clinical trial registration: The study protocol was registered and published in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number IRCT20090117001556N139).
期刊介绍:
PCN (Psychiatry and Clinical Neurosciences)
Publication Frequency:
Published 12 online issues a year by JSPN
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All manuscripts undergo peer review by anonymous reviewers, an Editorial Board Member, and the Editor
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Manuscripts are accepted based on quality, originality, and significance to the readership
Authors must confirm that the manuscript has not been published or submitted elsewhere and has been approved by each author