{"title":"氟西汀治疗中风后焦虑症的安全性和有效性--前瞻性随机开放盲法终点试验研究（PROBE）。","authors":"Satish Barki, Deepti Vibha, Sudhir Pachipala, Kamalesh Tayade, Shubham Misra, Manabesh Nath, Rajesh Kumar Singh, Nand Kumar","doi":"10.1177/00912174241296233","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The prevalence of post-stroke anxiety (PSA) is reported to be 20%-25%. There is insufficient evidence on the efficacy of antidepressants for treating anxiety in such patients. This Prospective Randomized Open Blinded Endpoint (PROBE) study was designed to assess the safety and efficacy of fluoxetine in PSA.</p><p><strong>Methods: </strong>In this single-center pilot study conducted in India, post-stroke patients (between 1 to 6 months) were randomized to fluoxetine (intervention group: 20 mg/day for 12 weeks) or standard medical care (control group). The primary outcome was improvement in the Hamilton Anxiety Rating Scale (HAM-A) at 12 weeks. The secondary outcomes were anxiety remission (>50% improvement in HAM-A), modified Rankin Scale (mRS), Barthel Index (BI), quality of life (SF-36), and Hamilton Depression Rating Scale (HAM-D). A linear regression analysis was done for determinants of HAM-A to account for baseline differences in the intervention and control groups.</p><p><strong>Results: </strong>A total of 60 patients were randomized: (30: intervention, 30: control). The overall prevalence of post-stroke anxiety among participants in the study was 50.8%, and 31.5% experienced both anxiety and depression. The average HAM-A score at baseline was 11, and average follow-up score at study conclusion was 4. There was similar improvement in the HAM-A score at 12 weeks post-randomization in the intervention and control groups [fluoxetine: -8.0 (95% CI = -11.0 to -4.0); control: -7.0 (95% CI = -9.5 to -4.0); <i>P</i> = 0.91]. Likewise, there was no significant difference between intervention and control groups at 12 weeks post-randomization on the mRS, BI, SF-36, or HAM-D. There were no serious adverse events in either group during the study.</p><p><strong>Conclusion: </strong>Fluoxetine and standard medical care had comparable improvement in HAM-A in post-stroke patients with mild anxiety at 12 weeks. Further study of the pharmacological treatment of post-stroke patients with more severe anxiety is needed.</p><p><strong>Clinical trial registration: </strong>CTRI/2018/12/016568.</p>","PeriodicalId":50294,"journal":{"name":"International Journal of Psychiatry in Medicine","volume":" ","pages":"912174241296233"},"PeriodicalIF":1.1000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of fluoxetine in post-stroke anxiety-A pilot prospective randomized open blinded endpoint (PROBE) study.\",\"authors\":\"Satish Barki, Deepti Vibha, Sudhir Pachipala, Kamalesh Tayade, Shubham Misra, Manabesh Nath, Rajesh Kumar Singh, Nand Kumar\",\"doi\":\"10.1177/00912174241296233\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The prevalence of post-stroke anxiety (PSA) is reported to be 20%-25%. There is insufficient evidence on the efficacy of antidepressants for treating anxiety in such patients. This Prospective Randomized Open Blinded Endpoint (PROBE) study was designed to assess the safety and efficacy of fluoxetine in PSA.</p><p><strong>Methods: </strong>In this single-center pilot study conducted in India, post-stroke patients (between 1 to 6 months) were randomized to fluoxetine (intervention group: 20 mg/day for 12 weeks) or standard medical care (control group). The primary outcome was improvement in the Hamilton Anxiety Rating Scale (HAM-A) at 12 weeks. The secondary outcomes were anxiety remission (>50% improvement in HAM-A), modified Rankin Scale (mRS), Barthel Index (BI), quality of life (SF-36), and Hamilton Depression Rating Scale (HAM-D). A linear regression analysis was done for determinants of HAM-A to account for baseline differences in the intervention and control groups.</p><p><strong>Results: </strong>A total of 60 patients were randomized: (30: intervention, 30: control). The overall prevalence of post-stroke anxiety among participants in the study was 50.8%, and 31.5% experienced both anxiety and depression. The average HAM-A score at baseline was 11, and average follow-up score at study conclusion was 4. There was similar improvement in the HAM-A score at 12 weeks post-randomization in the intervention and control groups [fluoxetine: -8.0 (95% CI = -11.0 to -4.0); control: -7.0 (95% CI = -9.5 to -4.0); <i>P</i> = 0.91]. Likewise, there was no significant difference between intervention and control groups at 12 weeks post-randomization on the mRS, BI, SF-36, or HAM-D. There were no serious adverse events in either group during the study.</p><p><strong>Conclusion: </strong>Fluoxetine and standard medical care had comparable improvement in HAM-A in post-stroke patients with mild anxiety at 12 weeks. Further study of the pharmacological treatment of post-stroke patients with more severe anxiety is needed.</p><p><strong>Clinical trial registration: </strong>CTRI/2018/12/016568.</p>\",\"PeriodicalId\":50294,\"journal\":{\"name\":\"International Journal of Psychiatry in Medicine\",\"volume\":\" \",\"pages\":\"912174241296233\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-10-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Psychiatry in Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/00912174241296233\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Psychiatry in Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/00912174241296233","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PSYCHIATRY","Score":null,"Total":0}
Safety and efficacy of fluoxetine in post-stroke anxiety-A pilot prospective randomized open blinded endpoint (PROBE) study.
Objective: The prevalence of post-stroke anxiety (PSA) is reported to be 20%-25%. There is insufficient evidence on the efficacy of antidepressants for treating anxiety in such patients. This Prospective Randomized Open Blinded Endpoint (PROBE) study was designed to assess the safety and efficacy of fluoxetine in PSA.
Methods: In this single-center pilot study conducted in India, post-stroke patients (between 1 to 6 months) were randomized to fluoxetine (intervention group: 20 mg/day for 12 weeks) or standard medical care (control group). The primary outcome was improvement in the Hamilton Anxiety Rating Scale (HAM-A) at 12 weeks. The secondary outcomes were anxiety remission (>50% improvement in HAM-A), modified Rankin Scale (mRS), Barthel Index (BI), quality of life (SF-36), and Hamilton Depression Rating Scale (HAM-D). A linear regression analysis was done for determinants of HAM-A to account for baseline differences in the intervention and control groups.
Results: A total of 60 patients were randomized: (30: intervention, 30: control). The overall prevalence of post-stroke anxiety among participants in the study was 50.8%, and 31.5% experienced both anxiety and depression. The average HAM-A score at baseline was 11, and average follow-up score at study conclusion was 4. There was similar improvement in the HAM-A score at 12 weeks post-randomization in the intervention and control groups [fluoxetine: -8.0 (95% CI = -11.0 to -4.0); control: -7.0 (95% CI = -9.5 to -4.0); P = 0.91]. Likewise, there was no significant difference between intervention and control groups at 12 weeks post-randomization on the mRS, BI, SF-36, or HAM-D. There were no serious adverse events in either group during the study.
Conclusion: Fluoxetine and standard medical care had comparable improvement in HAM-A in post-stroke patients with mild anxiety at 12 weeks. Further study of the pharmacological treatment of post-stroke patients with more severe anxiety is needed.
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The International Journal of Psychiatry in Medicine (IJPM) bridges the gap between clinical psychiatry research and primary care clinical research. Providing a forum for addressing: The relevance of psychobiological, psychological, social, familial, religious, and cultural factors in the development and treatment of illness; the relationship of biomarkers to psychiatric symptoms and syndromes in primary care...
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