Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects

The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double‐blind, placebo‐controlled, crossover design with two experimental test sessions to investigate the resp...

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Published in:	Clinical pharmacology and therapeutics Vol. 111; no. 4; pp. 886 - 895
Main Authors:	Becker, Anna M., Holze, Friederike, Grandinetti, Tanja, Klaiber, Aaron, Toedtli, Vanja E., Kolaczynska, Karolina E., Duthaler, Urs, Varghese, Nimmy, Eckert, Anne, Grünblatt, Edna, Liechti, Matthias E.
Format:	Journal Article
Language:	English
Published:	United States 01.04.2022
Subjects:	Antidepressive Agents - adverse effects Brain-Derived Neurotrophic Factor - genetics Citalopram - adverse effects Cross-Over Studies Double-Blind Method Escitalopram Healthy Volunteers Humans Psilocybin - adverse effects
ISSN:	0009-9236, 1532-6535, 1532-6535
Online Access:	Get full text
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Abstract	The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double‐blind, placebo‐controlled, crossover design with two experimental test sessions to investigate the response to psilocybin (25 mg) in healthy subjects after pretreatment with escitalopram or placebo. The treatment order was random and counterbalanced. Pretreatment consisted of 10 mg escitalopram daily for 7 days, followed by 20 mg daily for 7 days, including the day of psilocybin administration, or 14 days of placebo pretreatment before psilocybin administration. Psilocybin treatments were separated by at least 16 days. The outcome measures included self‐rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain‐derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole‐blood HTR2A and SCL6A4 gene expression, and pharmacokinetics. Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment. Escitalopram did not alter the pharmacokinetics of psilocin. The half‐life of psychoactive free (unconjugated) psilocin was 1.8 hours (range 1.1–2.2 hours), consistent with the short duration of action of psilocybin. Escitalopram did not alter HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels before or after psilocybin administration. Further studies are needed with a longer antidepressant pretreatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin.
AbstractList	The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double-blind, placebo-controlled, crossover design with two experimental test sessions to investigate the response to psilocybin (25 mg) in healthy subjects after pretreatment with escitalopram or placebo. The treatment order was random and counterbalanced. Pretreatment consisted of 10 mg escitalopram daily for 7 days, followed by 20 mg daily for 7 days, including the day of psilocybin administration, or 14 days of placebo pretreatment before psilocybin administration. Psilocybin treatments were separated by at least 16 days. The outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole-blood HTR2A and SCL6A4 gene expression, and pharmacokinetics. Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment. Escitalopram did not alter the pharmacokinetics of psilocin. The half-life of psychoactive free (unconjugated) psilocin was 1.8 hours (range 1.1-2.2 hours), consistent with the short duration of action of psilocybin. Escitalopram did not alter HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels before or after psilocybin administration. Further studies are needed with a longer antidepressant pretreatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin.The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double-blind, placebo-controlled, crossover design with two experimental test sessions to investigate the response to psilocybin (25 mg) in healthy subjects after pretreatment with escitalopram or placebo. The treatment order was random and counterbalanced. Pretreatment consisted of 10 mg escitalopram daily for 7 days, followed by 20 mg daily for 7 days, including the day of psilocybin administration, or 14 days of placebo pretreatment before psilocybin administration. Psilocybin treatments were separated by at least 16 days. The outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole-blood HTR2A and SCL6A4 gene expression, and pharmacokinetics. Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment. Escitalopram did not alter the pharmacokinetics of psilocin. The half-life of psychoactive free (unconjugated) psilocin was 1.8 hours (range 1.1-2.2 hours), consistent with the short duration of action of psilocybin. Escitalopram did not alter HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels before or after psilocybin administration. Further studies are needed with a longer antidepressant pretreatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin. The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with psilocybin. The present study used a double‐blind, placebo‐controlled, crossover design with two experimental test sessions to investigate the response to psilocybin (25 mg) in healthy subjects after pretreatment with escitalopram or placebo. The treatment order was random and counterbalanced. Pretreatment consisted of 10 mg escitalopram daily for 7 days, followed by 20 mg daily for 7 days, including the day of psilocybin administration, or 14 days of placebo pretreatment before psilocybin administration. Psilocybin treatments were separated by at least 16 days. The outcome measures included self‐rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain‐derived neurotrophic factor (BDNF) levels, electrocardiogram QTc time, whole‐blood HTR2A and SCL6A4 gene expression, and pharmacokinetics. Escitalopram pretreatment had no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment. Escitalopram did not alter the pharmacokinetics of psilocin. The half‐life of psychoactive free (unconjugated) psilocin was 1.8 hours (range 1.1–2.2 hours), consistent with the short duration of action of psilocybin. Escitalopram did not alter HTR2A or SCL6A4 gene expression before psilocybin administration, QTc intervals, or circulating BDNF levels before or after psilocybin administration. Further studies are needed with a longer antidepressant pretreatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin.
Author	Eckert, Anne Klaiber, Aaron Grünblatt, Edna Grandinetti, Tanja Kolaczynska, Karolina E. Varghese, Nimmy Liechti, Matthias E. Becker, Anna M. Toedtli, Vanja E. Duthaler, Urs Holze, Friederike
Author_xml	– sequence: 1 givenname: Anna M. surname: Becker fullname: Becker, Anna M. organization: University of Basel – sequence: 2 givenname: Friederike surname: Holze fullname: Holze, Friederike organization: University of Basel – sequence: 3 givenname: Tanja surname: Grandinetti fullname: Grandinetti, Tanja organization: University of Basel – sequence: 4 givenname: Aaron surname: Klaiber fullname: Klaiber, Aaron organization: University of Basel – sequence: 5 givenname: Vanja E. surname: Toedtli fullname: Toedtli, Vanja E. organization: University of Basel – sequence: 6 givenname: Karolina E. surname: Kolaczynska fullname: Kolaczynska, Karolina E. organization: University of Basel – sequence: 7 givenname: Urs orcidid: 0000-0002-7811-3932 surname: Duthaler fullname: Duthaler, Urs organization: University of Basel – sequence: 8 givenname: Nimmy orcidid: 0000-0001-8598-0535 surname: Varghese fullname: Varghese, Nimmy organization: University of Basel – sequence: 9 givenname: Anne surname: Eckert fullname: Eckert, Anne organization: University of Basel – sequence: 10 givenname: Edna surname: Grünblatt fullname: Grünblatt, Edna organization: University of Zurich – sequence: 11 givenname: Matthias E. orcidid: 0000-0002-1765-9659 surname: Liechti fullname: Liechti, Matthias E. email: matthias.liechti@usb.ch organization: University of Basel
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34743319$$D View this record in MEDLINE/PubMed
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Snippet	The psychedelic psilocybin is being investigated for the treatment of depression and anxiety. Unclear is whether antidepressant treatments interact with...
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SubjectTerms	Antidepressive Agents - adverse effects Brain-Derived Neurotrophic Factor - genetics Citalopram - adverse effects Cross-Over Studies Double-Blind Method Escitalopram Healthy Volunteers Humans Psilocybin - adverse effects
Title	Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects
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