大麻二酚作为急性双相抑郁的辅助治疗:一项初步研究。

IF 3.3 3区 医学 Q2 PSYCHIATRY Canadian Journal of Psychiatry-Revue Canadienne De Psychiatrie Pub Date : 2024-04-01 Epub Date: 2023-11-03 DOI:10.1177/07067437231209650
Jairo Vinícius Pinto, José Alexandre S Crippa, Keila Maria Ceresér, Miréia Fortes Vianna-Sulzbach, Érico de Moura Silveira Júnior, Gabriel Santana da Rosa, Manoella Guatimuzim Testa da Silva, Gabriel Henrique Hizo, Leonardo Simão Medeiros, Carlos Eduardo Santana de Oliveira, Giovana Bristot, Alline Cristina Campos, Francisco Silveira Guimarães, Jaime E C Hallak, Antonio W Zuardi, Lakshmi N Yatham, Flávio Kapczinski, Márcia Kauer-Sant'Anna
{"title":"大麻二酚作为急性双相抑郁的辅助治疗:一项初步研究。","authors":"Jairo Vinícius Pinto, José Alexandre S Crippa, Keila Maria Ceresér, Miréia Fortes Vianna-Sulzbach, Érico de Moura Silveira Júnior, Gabriel Santana da Rosa, Manoella Guatimuzim Testa da Silva, Gabriel Henrique Hizo, Leonardo Simão Medeiros, Carlos Eduardo Santana de Oliveira, Giovana Bristot, Alline Cristina Campos, Francisco Silveira Guimarães, Jaime E C Hallak, Antonio W Zuardi, Lakshmi N Yatham, Flávio Kapczinski, Márcia Kauer-Sant'Anna","doi":"10.1177/07067437231209650","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The treatment of bipolar depression remains challenging due to the limited effective and safe therapeutic options available; thus, developing newer treatments that are effective and well tolerable is an urgent unmet need. The objective of the present trial was to test 150 to 300 mg/day of cannabidiol as an adjunctive treatment for bipolar depression.</p><p><strong>Method: </strong>A randomized, double-blind, placebo-controlled pilot study to assess the efficacy of adjunctive cannabidiol in bipolar depression was used. Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 8. Secondary outcomes included response and remission rates, changes in anxiety and psychotic symptoms, and changes in functioning. Patients continued double-blind treatment until week 12 to monitor for adverse effects, laboratory analysis, and manic symptoms. Study registry: NCT03310593.</p><p><strong>Results: </strong>A total of 35 participants were included. MADRS scores significantly decreased from baseline to the endpoint (placebo, -14.56; cannabidiol, -15.38), but there was no significant difference between the groups. Similarly, there were no other significant effects on the secondary outcomes. However, an exploratory analysis showed a significant effect of cannabidiol 300 mg/day in reducing MADRS scores from week 2 to week 8 (placebo, -6.64; cannabidiol, -13.72). There were no significant differences in the development of manic symptoms or any other adverse effects.</p><p><strong>Conclusion: </strong>Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an exploratory analysis suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response.</p>","PeriodicalId":55283,"journal":{"name":"Canadian Journal of Psychiatry-Revue Canadienne De Psychiatrie","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10924581/pdf/","citationCount":"0","resultStr":"{\"title\":\"Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la dépression bipolaire aiguë : une étude pilote.\",\"authors\":\"Jairo Vinícius Pinto, José Alexandre S Crippa, Keila Maria Ceresér, Miréia Fortes Vianna-Sulzbach, Érico de Moura Silveira Júnior, Gabriel Santana da Rosa, Manoella Guatimuzim Testa da Silva, Gabriel Henrique Hizo, Leonardo Simão Medeiros, Carlos Eduardo Santana de Oliveira, Giovana Bristot, Alline Cristina Campos, Francisco Silveira Guimarães, Jaime E C Hallak, Antonio W Zuardi, Lakshmi N Yatham, Flávio Kapczinski, Márcia Kauer-Sant'Anna\",\"doi\":\"10.1177/07067437231209650\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The treatment of bipolar depression remains challenging due to the limited effective and safe therapeutic options available; thus, developing newer treatments that are effective and well tolerable is an urgent unmet need. The objective of the present trial was to test 150 to 300 mg/day of cannabidiol as an adjunctive treatment for bipolar depression.</p><p><strong>Method: </strong>A randomized, double-blind, placebo-controlled pilot study to assess the efficacy of adjunctive cannabidiol in bipolar depression was used. Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 8. Secondary outcomes included response and remission rates, changes in anxiety and psychotic symptoms, and changes in functioning. Patients continued double-blind treatment until week 12 to monitor for adverse effects, laboratory analysis, and manic symptoms. Study registry: NCT03310593.</p><p><strong>Results: </strong>A total of 35 participants were included. MADRS scores significantly decreased from baseline to the endpoint (placebo, -14.56; cannabidiol, -15.38), but there was no significant difference between the groups. Similarly, there were no other significant effects on the secondary outcomes. However, an exploratory analysis showed a significant effect of cannabidiol 300 mg/day in reducing MADRS scores from week 2 to week 8 (placebo, -6.64; cannabidiol, -13.72). There were no significant differences in the development of manic symptoms or any other adverse effects.</p><p><strong>Conclusion: </strong>Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an exploratory analysis suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response.</p>\",\"PeriodicalId\":55283,\"journal\":{\"name\":\"Canadian Journal of Psychiatry-Revue Canadienne De Psychiatrie\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10924581/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Canadian Journal of Psychiatry-Revue Canadienne De Psychiatrie\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/07067437231209650\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/11/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Journal of Psychiatry-Revue Canadienne De Psychiatrie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/07067437231209650","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/3 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PSYCHIATRY","Score":null,"Total":0}
引用次数: 0

摘要

目的:由于有效和安全的治疗选择有限,双相抑郁症的治疗仍然具有挑战性;因此,开发有效且耐受性良好的新型治疗方法是一个亟待满足的需求。本试验的目的是测试150至300 mg/天的大麻二酚作为双相抑郁症的辅助治疗。方法:采用随机、双盲、安慰剂对照的初步研究来评估辅助大麻二酚治疗双相抑郁症的疗效。疗效参数是Montgomery-Åsberg抑郁评定量表(MADRS)从基线到第8周的变化。次要结果包括反应率和缓解率、焦虑和精神病症状的变化以及功能的变化。患者持续双盲治疗至第12周,以监测不良反应、实验室分析和躁狂症状。研究登记:NCT03310593。结果:共有35名参与者被纳入。MADRS评分从基线到终点显著下降(安慰剂,-14.56;大麻二酚,-15.38),但两组之间没有显著差异。同样,对次要结果没有其他显著影响。然而,一项探索性分析显示,大麻二酚300具有显著作用 mg/天,从第2周到第8周降低MADRS评分(安慰剂,-6.64;大麻二酚,-13.72)。在躁狂症状或任何其他不良反应的发展方面没有显著差异。结论:大麻二酚的不良反应并不明显高于安慰剂。尽管主要结果为阴性,但一项探索性分析表明,大麻二酚应在双相抑郁症中以至少300的更高剂量进行进一步研究 mg/天,并且正在进行可以更好地控制高安慰剂反应的研究设计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la dépression bipolaire aiguë : une étude pilote.

Objective: The treatment of bipolar depression remains challenging due to the limited effective and safe therapeutic options available; thus, developing newer treatments that are effective and well tolerable is an urgent unmet need. The objective of the present trial was to test 150 to 300 mg/day of cannabidiol as an adjunctive treatment for bipolar depression.

Method: A randomized, double-blind, placebo-controlled pilot study to assess the efficacy of adjunctive cannabidiol in bipolar depression was used. Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 8. Secondary outcomes included response and remission rates, changes in anxiety and psychotic symptoms, and changes in functioning. Patients continued double-blind treatment until week 12 to monitor for adverse effects, laboratory analysis, and manic symptoms. Study registry: NCT03310593.

Results: A total of 35 participants were included. MADRS scores significantly decreased from baseline to the endpoint (placebo, -14.56; cannabidiol, -15.38), but there was no significant difference between the groups. Similarly, there were no other significant effects on the secondary outcomes. However, an exploratory analysis showed a significant effect of cannabidiol 300 mg/day in reducing MADRS scores from week 2 to week 8 (placebo, -6.64; cannabidiol, -13.72). There were no significant differences in the development of manic symptoms or any other adverse effects.

Conclusion: Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an exploratory analysis suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
7.00
自引率
2.50%
发文量
69
审稿时长
6-12 weeks
期刊介绍: Established in 1956, The Canadian Journal of Psychiatry (The CJP) has been keeping psychiatrists up-to-date on the latest research for nearly 60 years. The CJP provides a forum for psychiatry and mental health professionals to share their findings with researchers and clinicians. The CJP includes peer-reviewed scientific articles analyzing ongoing developments in Canadian and international psychiatry.
期刊最新文献
Access to University Mental Health Services: Understanding the Student Experience: L'accès aux services universitaires de santé mentale : comprendre l'expérience des étudiants. Formal Thought Disorders and Neurocognition in Treatment-Resistant Schizophrenia: Trouble du cours de la pensée et neurocognition dans la schizophrénie réfractaire. Psychosis and Gender: A Focus on Women in the Global South. Procognitive Effects of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation in Major Depressive Disorder: Effets procognitifs de la D-cyclosérine en traitement complémentaire par la stimulation thêta-burst intermittente dans le trouble dépressif caractérisé. Impacts and Implications of Cannabis Legalization on Key Outcomes Among Adolescents in Canada.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1