دورية أكاديمية
Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects: A double blind multicenter randomized clinical trial.
| العنوان: | Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects: A double blind multicenter randomized clinical trial. |
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| المؤلفون: | Gundugurti PR; Asha Hospital, 443, Venkat Nagar, Banjara Hills, Hyderabad, Telangana 500034, India. Electronic address: prasad40@gmail.com., Banda N; Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India., Yadlapalli SSR; Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India., Narala A; Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India., Thatikonda R; Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India., Kocherlakota C; Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India. Electronic address: kcs@leiutis.com., Kothapalli KS; Biophore Pharma Inc, 4262 US-1 Suite A, Monmouth Junction, NJ 08852, USA. Electronic address: kumar.kothapalli@biophore.com. |
| المصدر: | Asian journal of psychiatry [Asian J Psychiatr] 2024 Jul; Vol. 97, pp. 104073. Date of Electronic Publication: 2024 May 18. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 101517820 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-2026 (Electronic) Linking ISSN: 18762018 NLM ISO Abbreviation: Asian J Psychiatr Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Amsterdam] : Elsevier |
| مواضيع طبية MeSH: | Cannabidiol*/administration & dosage , Cannabidiol*/adverse effects , Cannabidiol*/pharmacokinetics , Cannabidiol*/pharmacology , Anxiety Disorders*/drug therapy, Humans ; Double-Blind Method ; Adult ; Male ; Female ; Middle Aged ; Administration, Oral ; Anti-Anxiety Agents/administration & dosage ; Anti-Anxiety Agents/adverse effects ; Anti-Anxiety Agents/pharmacokinetics ; Young Adult ; India ; Outcome Assessment, Health Care ; Treatment Outcome |
| مستخلص: | Background: Anxiety disorders, an increasingly prevalent global mental health illness, affected approximately 301 million individuals worldwide in 2019. There is an unmet need for the treatment of anxiety disorders, as current therapies are associated with limited response rates, residual symptoms, and adverse effects. Objectives: To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders. Methods: This phase 3 prospective, randomized, double blind, parallel group, placebo-controlled, 15-week cohort study took place at multiple sites across India. Eligible participants were randomly assigned to one of the two treatment arms (CBD or placebo) in a 1:1 ratio. Results: 178 participants were randomized to receive CBD (n=89) or placebo (n=89). The study met both primary (GAD-7 and HAM-A scores) and secondary outcomes (CGI-I, CGI-S, PHQ-9 and PSQI scores). The GAD-7 score difference between the end of treatment and baseline for the CBD versus the placebo was -7.02 (S.E: 0.25, 95% CI -7.52; -6.52), p<0.0001. Similarly, the HAM-A score difference at the end of treatment compared to baseline for the CBD versus the placebo was -11.9 (S.E: 0.33, 95% CI -12.6; -11.3), p<0.0001. Conclusions: Nanodispersible CBD was therapeutically safe with no serious adverse events, well tolerated, and effective for the treatment of mild to moderate anxiety disorders, as well as associated depression and sleep quality disturbances. These results pave way for probable prospective use of nanodispersible CBD formulation for various psychiatry disorders alone or in conjunction with other drugs. Competing Interests: Declaration of Competing Interest CK is the Board member and CEO of Leiutis Pharmaceuticals LLP, KSDK is the Chief Medical Officer of Biophore Pharma, Inc., PRG is the Lead Investigator of the Clinical Trial. NB, SSRY, AN, RT are employees of Leiutis Pharmaceuticals LLP. (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Adverse effects; Anxiety disorders; Cannabidiol; Nanodispersible; Pharmacokinetics |
| المشرفين على المادة: | 19GBJ60SN5 (Cannabidiol) 0 (Anti-Anxiety Agents) |
| تواريخ الأحداث: | Date Created: 20240526 Date Completed: 20240614 Latest Revision: 20240614 |
| رمز التحديث: | 20240615 |
| DOI: | 10.1016/j.ajp.2024.104073 |
| PMID: | 38797087 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1876-2026 |
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| DOI: | 10.1016/j.ajp.2024.104073 |