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
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...
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| Veröffentlicht in: | Asian journal of psychiatry 2024-07, Vol.97, p.104073, Article 104073 |
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| creator | Gundugurti, Prasad Rao Banda, Nagaraju Yadlapalli, Siva Sankara Rao Narala, Arjun Thatikonda, Ramyasree Kocherlakota, Chandrashekhar Kothapalli, Kumar SD |
| description | 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.
To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders.
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.
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 |
| doi_str_mv | 10.1016/j.ajp.2024.104073 |
| format | Article |
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To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders.
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.
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.
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.
•Nanodispersible CBD oral solution was effective treating mild to moderate anxiety.•Nanodispersible CBD reduced GAD-7 and HAM-A scores (primary outcome).•Nanodispersible CBD reduced CGI-I, CGI-S, PHQ-9, and PSQI scores (secondary outcomes).•Nanodispersible CBD showed good tolerability, with no serious adverse events.</description><identifier>ISSN: 1876-2018</identifier><identifier>ISSN: 1876-2026</identifier><identifier>EISSN: 1876-2026</identifier><identifier>DOI: 10.1016/j.ajp.2024.104073</identifier><identifier>PMID: 38797087</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Administration, Oral ; Adult ; Adverse effects ; Anti-Anxiety Agents - administration & dosage ; Anti-Anxiety Agents - adverse effects ; Anti-Anxiety Agents - pharmacokinetics ; Anxiety disorders ; Anxiety Disorders - drug therapy ; Cannabidiol ; Cannabidiol - administration & dosage ; Cannabidiol - adverse effects ; Cannabidiol - pharmacokinetics ; Cannabidiol - pharmacology ; Double-Blind Method ; Female ; Humans ; India ; Male ; Middle Aged ; Nanodispersible ; Outcome Assessment, Health Care ; Pharmacokinetics ; Treatment Outcome ; Young Adult</subject><ispartof>Asian journal of psychiatry, 2024-07, Vol.97, p.104073, Article 104073</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c348t-d4c66352750833ea062b4d7eb5b4f40b3ae13c879e2ff1684a2440cefce14bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1876201824001667$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38797087$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gundugurti, Prasad Rao</creatorcontrib><creatorcontrib>Banda, Nagaraju</creatorcontrib><creatorcontrib>Yadlapalli, Siva Sankara Rao</creatorcontrib><creatorcontrib>Narala, Arjun</creatorcontrib><creatorcontrib>Thatikonda, Ramyasree</creatorcontrib><creatorcontrib>Kocherlakota, Chandrashekhar</creatorcontrib><creatorcontrib>Kothapalli, Kumar SD</creatorcontrib><title>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</title><title>Asian journal of psychiatry</title><addtitle>Asian J Psychiatr</addtitle><description>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.
To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders.
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.
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.
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.
•Nanodispersible CBD oral solution was effective treating mild to moderate anxiety.•Nanodispersible CBD reduced GAD-7 and HAM-A scores (primary outcome).•Nanodispersible CBD reduced CGI-I, CGI-S, PHQ-9, and PSQI scores (secondary outcomes).•Nanodispersible CBD showed good tolerability, with no serious adverse events.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Adverse effects</subject><subject>Anti-Anxiety Agents - administration & dosage</subject><subject>Anti-Anxiety Agents - adverse effects</subject><subject>Anti-Anxiety Agents - pharmacokinetics</subject><subject>Anxiety disorders</subject><subject>Anxiety Disorders - drug therapy</subject><subject>Cannabidiol</subject><subject>Cannabidiol - administration & dosage</subject><subject>Cannabidiol - adverse effects</subject><subject>Cannabidiol - pharmacokinetics</subject><subject>Cannabidiol - pharmacology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>India</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nanodispersible</subject><subject>Outcome Assessment, Health Care</subject><subject>Pharmacokinetics</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1876-2018</issn><issn>1876-2026</issn><issn>1876-2026</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UctuFDEQHCEQCYEP4IJ8DBK7sceeB3CKogSQVuKSu9W2e4gXPwbbsyKc-CO-iAtfEi8bcuTUdru6qtzVNC8ZXTPK-rPtGrbzuqWtqHdBB_6oOWbj0K9qq3_8cGbjUfMs5y2l_cjF8LQ54uPwdqDjcNz8vtyBW6DYGEicSLlBgtNkNejbNyTDhKVWCIbMN5A86PjVBixW5z06QIjG5hlTtsoh0RACKGtsdCQmcCRHt_ylPmUd_fPzl_9y5jevya4OLJnMDjSqSGwg3jpDSiQ-GkxQsEp-t1Wb5EVtUZf8jpwTE5e9inK2-vGLqzYwFEwkVYPR2x9oiK6P1b0jJVlwz5snE7iML-7rSXN9dXl98XG1-fzh08X5ZqW5GMvKCN33vGuHjo6cI9C-VcIMqDolJkEVB2Rc151hO02sHwW0QlCNk0YmlOYnzemBdk7x24K5SG-zRucgYFyy5LSnQ9fybqxQdoDqFHNOOMk5WQ_pVjIq96HKrayhyn2o8hBqnXl1T78oj-Zh4l-KFfD-AMD6x53FJLO2GDQam-rypIn2P_R3y7K4aA</recordid><startdate>202407</startdate><enddate>202407</enddate><creator>Gundugurti, Prasad Rao</creator><creator>Banda, Nagaraju</creator><creator>Yadlapalli, Siva Sankara Rao</creator><creator>Narala, Arjun</creator><creator>Thatikonda, Ramyasree</creator><creator>Kocherlakota, Chandrashekhar</creator><creator>Kothapalli, Kumar SD</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202407</creationdate><title>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</title><author>Gundugurti, Prasad Rao ; 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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.
To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders.
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.
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.
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.
•Nanodispersible CBD oral solution was effective treating mild to moderate anxiety.•Nanodispersible CBD reduced GAD-7 and HAM-A scores (primary outcome).•Nanodispersible CBD reduced CGI-I, CGI-S, PHQ-9, and PSQI scores (secondary outcomes).•Nanodispersible CBD showed good tolerability, with no serious adverse events.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>38797087</pmid><doi>10.1016/j.ajp.2024.104073</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1876-2018 |
| ispartof | Asian journal of psychiatry, 2024-07, Vol.97, p.104073, Article 104073 |
| issn | 1876-2018 1876-2026 1876-2026 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Administration, Oral Adult Adverse effects Anti-Anxiety Agents - administration & dosage Anti-Anxiety Agents - adverse effects Anti-Anxiety Agents - pharmacokinetics Anxiety disorders Anxiety Disorders - drug therapy Cannabidiol Cannabidiol - administration & dosage Cannabidiol - adverse effects Cannabidiol - pharmacokinetics Cannabidiol - pharmacology Double-Blind Method Female Humans India Male Middle Aged Nanodispersible Outcome Assessment, Health Care Pharmacokinetics Treatment Outcome Young Adult |
| title | 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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