Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial
Background: Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature. Metho...
Gespeichert in:
| Veröffentlicht in: | Journal of psychopharmacology (Oxford) 2023-07, Vol.37 (7), p.698-706 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 706 |
|---|---|
| container_issue | 7 |
| container_start_page | 698 |
| container_title | Journal of psychopharmacology (Oxford) |
| container_volume | 37 |
| creator | Sloshower, Jordan Skosnik, Patrick D. Safi-Aghdam, Hamideh Pathania, Surbhi Syed, Shariful Pittman, Brian D’Souza, Deepak Cyril |
| description | Background:
Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature.
Methods:
In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe major depressive disorder were administered placebo (n = 19) followed by psilocybin (0.3 mg/kg) (n = 15) 4 weeks later. Dosing sessions were embedded within an manualized course of psychotherapy. Enhanced blinding procedures were used. Depression, anxiety, and quality of life were measured over a 16-week study period.
Results:
Depression and anxiety significantly improved following both placebo and psilocybin with no significant difference in the degree of change between the two conditions. However, antidepressant effect sizes were larger after psilocybin (d′ = 1.02–2.27) than after placebo (d′ = 0.65–0.99) and there were high rates of response (66.7%) and remission (46.7%) following psilocybin administration. Antidepressant effects following psilocybin persisted, on average, for 2 months and there were persisting improvements in mood-related quality of life domains. The strength of mystical-type experience during psilocybin dosing was not correlated with subsequent antidepressant effects.
Conclusions:
The results of this exploratory study highlight the complex interplay between expectancy, therapy effects, and drug/placebo effects in psychedelic-assisted psychotherapy studies. Nonetheless, the acute and persisting clinical improvements observed following psilocybin support further study of its potential in the treatment of major depression. Future studies should more explicitly mitigate and measure expectancy effects and assess the impact of repeated dosing and different forms of psychotherapeutic support. |
| doi_str_mv | 10.1177/02698811231154852 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2788796799</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_02698811231154852</sage_id><sourcerecordid>2836773669</sourcerecordid><originalsourceid>FETCH-LOGICAL-c368t-a4d01ab3ee044e9d11e140f688d8e28acc7424cbc0493cc5625b566dab2ee6a73</originalsourceid><addsrcrecordid>eNp1kU9P3DAQxa2qFWwpH4BLZakXDoR6bMd_uCEELRJSe6DnyLEnNCtvHOwsYr89WZa2UhGXmcP7vTejGUKOgJ0CaP2VcWWNAeACoJam5u_IAqSCSnNTvyeLrV5tgX3ysZQlY6CkqvfIvlBWGGthQdLP0sfkN20_VK6UvkwY6PQbsxs3tEuZrtxyrgHHjLP8gDT0JeWA-YyeDxQfx5iym1Le0DE6j22qfBqmnGLEcEK7_hFD9czTKfcufiIfOhcLHr70A_Lr6vL24nt18-Pb9cX5TeWFMlPlZGDgWoHIpEQbABAk65QxwSA3znstufStZ9IK72vF67ZWKriWIyqnxQE53uWOOd2vsUzNqi8eY3QDpnVpuDZGW6WtndEv_6HLtM7DvF3DjVBaC6W2FOwon1MpGbtmzP3K5U0DrNl-o3n1jdnz-SV53a4w_HX8Of8MnO6A4u7w39i3E58AleuTpw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2836773669</pqid></control><display><type>article</type><title>Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial</title><source>SAGE Publications</source><source>MEDLINE</source><creator>Sloshower, Jordan ; Skosnik, Patrick D. ; Safi-Aghdam, Hamideh ; Pathania, Surbhi ; Syed, Shariful ; Pittman, Brian ; D’Souza, Deepak Cyril</creator><creatorcontrib>Sloshower, Jordan ; Skosnik, Patrick D. ; Safi-Aghdam, Hamideh ; Pathania, Surbhi ; Syed, Shariful ; Pittman, Brian ; D’Souza, Deepak Cyril</creatorcontrib><description>Background:
Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature.
Methods:
In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe major depressive disorder were administered placebo (n = 19) followed by psilocybin (0.3 mg/kg) (n = 15) 4 weeks later. Dosing sessions were embedded within an manualized course of psychotherapy. Enhanced blinding procedures were used. Depression, anxiety, and quality of life were measured over a 16-week study period.
Results:
Depression and anxiety significantly improved following both placebo and psilocybin with no significant difference in the degree of change between the two conditions. However, antidepressant effect sizes were larger after psilocybin (d′ = 1.02–2.27) than after placebo (d′ = 0.65–0.99) and there were high rates of response (66.7%) and remission (46.7%) following psilocybin administration. Antidepressant effects following psilocybin persisted, on average, for 2 months and there were persisting improvements in mood-related quality of life domains. The strength of mystical-type experience during psilocybin dosing was not correlated with subsequent antidepressant effects.
Conclusions:
The results of this exploratory study highlight the complex interplay between expectancy, therapy effects, and drug/placebo effects in psychedelic-assisted psychotherapy studies. Nonetheless, the acute and persisting clinical improvements observed following psilocybin support further study of its potential in the treatment of major depression. Future studies should more explicitly mitigate and measure expectancy effects and assess the impact of repeated dosing and different forms of psychotherapeutic support.</description><identifier>ISSN: 0269-8811</identifier><identifier>EISSN: 1461-7285</identifier><identifier>DOI: 10.1177/02698811231154852</identifier><identifier>PMID: 36938991</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Antidepressants ; Antidepressive Agents - pharmacology ; Antidepressive Agents - therapeutic use ; Anxiety ; Depressive Disorder, Major - drug therapy ; Dosage ; Expectancy ; Hallucinogens - pharmacology ; Hallucinogens - therapeutic use ; Humans ; Mental depression ; Placebos ; Psilocybin ; Psilocybin - pharmacology ; Psilocybin - therapeutic use ; Psychedelic drugs ; Psychotherapy ; Quality of Life ; Remission</subject><ispartof>Journal of psychopharmacology (Oxford), 2023-07, Vol.37 (7), p.698-706</ispartof><rights>The Author(s) 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c368t-a4d01ab3ee044e9d11e140f688d8e28acc7424cbc0493cc5625b566dab2ee6a73</citedby><cites>FETCH-LOGICAL-c368t-a4d01ab3ee044e9d11e140f688d8e28acc7424cbc0493cc5625b566dab2ee6a73</cites><orcidid>0000-0001-6093-2625 ; 0000-0001-7709-5931 ; 0000-0002-8636-8089</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/02698811231154852$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/02698811231154852$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21818,27923,27924,43620,43621</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36938991$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sloshower, Jordan</creatorcontrib><creatorcontrib>Skosnik, Patrick D.</creatorcontrib><creatorcontrib>Safi-Aghdam, Hamideh</creatorcontrib><creatorcontrib>Pathania, Surbhi</creatorcontrib><creatorcontrib>Syed, Shariful</creatorcontrib><creatorcontrib>Pittman, Brian</creatorcontrib><creatorcontrib>D’Souza, Deepak Cyril</creatorcontrib><title>Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial</title><title>Journal of psychopharmacology (Oxford)</title><addtitle>J Psychopharmacol</addtitle><description>Background:
Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature.
Methods:
In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe major depressive disorder were administered placebo (n = 19) followed by psilocybin (0.3 mg/kg) (n = 15) 4 weeks later. Dosing sessions were embedded within an manualized course of psychotherapy. Enhanced blinding procedures were used. Depression, anxiety, and quality of life were measured over a 16-week study period.
Results:
Depression and anxiety significantly improved following both placebo and psilocybin with no significant difference in the degree of change between the two conditions. However, antidepressant effect sizes were larger after psilocybin (d′ = 1.02–2.27) than after placebo (d′ = 0.65–0.99) and there were high rates of response (66.7%) and remission (46.7%) following psilocybin administration. Antidepressant effects following psilocybin persisted, on average, for 2 months and there were persisting improvements in mood-related quality of life domains. The strength of mystical-type experience during psilocybin dosing was not correlated with subsequent antidepressant effects.
Conclusions:
The results of this exploratory study highlight the complex interplay between expectancy, therapy effects, and drug/placebo effects in psychedelic-assisted psychotherapy studies. Nonetheless, the acute and persisting clinical improvements observed following psilocybin support further study of its potential in the treatment of major depression. Future studies should more explicitly mitigate and measure expectancy effects and assess the impact of repeated dosing and different forms of psychotherapeutic support.</description><subject>Antidepressants</subject><subject>Antidepressive Agents - pharmacology</subject><subject>Antidepressive Agents - therapeutic use</subject><subject>Anxiety</subject><subject>Depressive Disorder, Major - drug therapy</subject><subject>Dosage</subject><subject>Expectancy</subject><subject>Hallucinogens - pharmacology</subject><subject>Hallucinogens - therapeutic use</subject><subject>Humans</subject><subject>Mental depression</subject><subject>Placebos</subject><subject>Psilocybin</subject><subject>Psilocybin - pharmacology</subject><subject>Psilocybin - therapeutic use</subject><subject>Psychedelic drugs</subject><subject>Psychotherapy</subject><subject>Quality of Life</subject><subject>Remission</subject><issn>0269-8811</issn><issn>1461-7285</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU9P3DAQxa2qFWwpH4BLZakXDoR6bMd_uCEELRJSe6DnyLEnNCtvHOwsYr89WZa2UhGXmcP7vTejGUKOgJ0CaP2VcWWNAeACoJam5u_IAqSCSnNTvyeLrV5tgX3ysZQlY6CkqvfIvlBWGGthQdLP0sfkN20_VK6UvkwY6PQbsxs3tEuZrtxyrgHHjLP8gDT0JeWA-YyeDxQfx5iym1Le0DE6j22qfBqmnGLEcEK7_hFD9czTKfcufiIfOhcLHr70A_Lr6vL24nt18-Pb9cX5TeWFMlPlZGDgWoHIpEQbABAk65QxwSA3znstufStZ9IK72vF67ZWKriWIyqnxQE53uWOOd2vsUzNqi8eY3QDpnVpuDZGW6WtndEv_6HLtM7DvF3DjVBaC6W2FOwon1MpGbtmzP3K5U0DrNl-o3n1jdnz-SV53a4w_HX8Of8MnO6A4u7w39i3E58AleuTpw</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Sloshower, Jordan</creator><creator>Skosnik, Patrick D.</creator><creator>Safi-Aghdam, Hamideh</creator><creator>Pathania, Surbhi</creator><creator>Syed, Shariful</creator><creator>Pittman, Brian</creator><creator>D’Souza, Deepak Cyril</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><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>7TK</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6093-2625</orcidid><orcidid>https://orcid.org/0000-0001-7709-5931</orcidid><orcidid>https://orcid.org/0000-0002-8636-8089</orcidid></search><sort><creationdate>202307</creationdate><title>Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial</title><author>Sloshower, Jordan ; Skosnik, Patrick D. ; Safi-Aghdam, Hamideh ; Pathania, Surbhi ; Syed, Shariful ; Pittman, Brian ; D’Souza, Deepak Cyril</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c368t-a4d01ab3ee044e9d11e140f688d8e28acc7424cbc0493cc5625b566dab2ee6a73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antidepressants</topic><topic>Antidepressive Agents - pharmacology</topic><topic>Antidepressive Agents - therapeutic use</topic><topic>Anxiety</topic><topic>Depressive Disorder, Major - drug therapy</topic><topic>Dosage</topic><topic>Expectancy</topic><topic>Hallucinogens - pharmacology</topic><topic>Hallucinogens - therapeutic use</topic><topic>Humans</topic><topic>Mental depression</topic><topic>Placebos</topic><topic>Psilocybin</topic><topic>Psilocybin - pharmacology</topic><topic>Psilocybin - therapeutic use</topic><topic>Psychedelic drugs</topic><topic>Psychotherapy</topic><topic>Quality of Life</topic><topic>Remission</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sloshower, Jordan</creatorcontrib><creatorcontrib>Skosnik, Patrick D.</creatorcontrib><creatorcontrib>Safi-Aghdam, Hamideh</creatorcontrib><creatorcontrib>Pathania, Surbhi</creatorcontrib><creatorcontrib>Syed, Shariful</creatorcontrib><creatorcontrib>Pittman, Brian</creatorcontrib><creatorcontrib>D’Souza, Deepak Cyril</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of psychopharmacology (Oxford)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sloshower, Jordan</au><au>Skosnik, Patrick D.</au><au>Safi-Aghdam, Hamideh</au><au>Pathania, Surbhi</au><au>Syed, Shariful</au><au>Pittman, Brian</au><au>D’Souza, Deepak Cyril</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial</atitle><jtitle>Journal of psychopharmacology (Oxford)</jtitle><addtitle>J Psychopharmacol</addtitle><date>2023-07</date><risdate>2023</risdate><volume>37</volume><issue>7</issue><spage>698</spage><epage>706</epage><pages>698-706</pages><issn>0269-8811</issn><eissn>1461-7285</eissn><abstract>Background:
Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature.
Methods:
In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe major depressive disorder were administered placebo (n = 19) followed by psilocybin (0.3 mg/kg) (n = 15) 4 weeks later. Dosing sessions were embedded within an manualized course of psychotherapy. Enhanced blinding procedures were used. Depression, anxiety, and quality of life were measured over a 16-week study period.
Results:
Depression and anxiety significantly improved following both placebo and psilocybin with no significant difference in the degree of change between the two conditions. However, antidepressant effect sizes were larger after psilocybin (d′ = 1.02–2.27) than after placebo (d′ = 0.65–0.99) and there were high rates of response (66.7%) and remission (46.7%) following psilocybin administration. Antidepressant effects following psilocybin persisted, on average, for 2 months and there were persisting improvements in mood-related quality of life domains. The strength of mystical-type experience during psilocybin dosing was not correlated with subsequent antidepressant effects.
Conclusions:
The results of this exploratory study highlight the complex interplay between expectancy, therapy effects, and drug/placebo effects in psychedelic-assisted psychotherapy studies. Nonetheless, the acute and persisting clinical improvements observed following psilocybin support further study of its potential in the treatment of major depression. Future studies should more explicitly mitigate and measure expectancy effects and assess the impact of repeated dosing and different forms of psychotherapeutic support.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>36938991</pmid><doi>10.1177/02698811231154852</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6093-2625</orcidid><orcidid>https://orcid.org/0000-0001-7709-5931</orcidid><orcidid>https://orcid.org/0000-0002-8636-8089</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0269-8811 |
| ispartof | Journal of psychopharmacology (Oxford), 2023-07, Vol.37 (7), p.698-706 |
| issn | 0269-8811 1461-7285 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2788796799 |
| source | SAGE Publications; MEDLINE |
| subjects | Antidepressants Antidepressive Agents - pharmacology Antidepressive Agents - therapeutic use Anxiety Depressive Disorder, Major - drug therapy Dosage Expectancy Hallucinogens - pharmacology Hallucinogens - therapeutic use Humans Mental depression Placebos Psilocybin Psilocybin - pharmacology Psilocybin - therapeutic use Psychedelic drugs Psychotherapy Quality of Life Remission |
| title | Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-10T15%3A17%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Psilocybin-assisted%20therapy%20for%20major%20depressive%20disorder:%20An%20exploratory%20placebo-controlled,%20fixed-order%20trial&rft.jtitle=Journal%20of%20psychopharmacology%20(Oxford)&rft.au=Sloshower,%20Jordan&rft.date=2023-07&rft.volume=37&rft.issue=7&rft.spage=698&rft.epage=706&rft.pages=698-706&rft.issn=0269-8811&rft.eissn=1461-7285&rft_id=info:doi/10.1177/02698811231154852&rft_dat=%3Cproquest_cross%3E2836773669%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2836773669&rft_id=info:pmid/36938991&rft_sage_id=10.1177_02698811231154852&rfr_iscdi=true |