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.

IF 3.3 3区 医学 Q2 PSYCHIATRY
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
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Abstract

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.

大麻二酚作为急性双相抑郁的辅助治疗:一项初步研究。
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。
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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.
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