NCT03912974

Brief Summary

Psilocybin is a classic serotonergic hallucinogen acting on the 5-HT2A receptor. It is used recreationally and in psychiatric research. Selective serotonin reuptake inhibitors (SSRIs) like escitalopram are first-line treatments for depression. They inhibit the serotonin transporter (SERT). This might cause a possible downregulation of postsynaptic 5-HT receptors, e.g. the 5-HT2A receptor. The aim of the study is to investigate the effects of psilocybin after escitalopram and Placebo pretreatment. Subjective and physiological effects as well as effects on gene expression will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

March 6, 2019

Last Update Submit

November 30, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 5 dimensions of altered state of consciousness (5D-ASC) profile total score

    Visual analog scale consisting of 94 items. Constructed of five scales and allows assessing mood, anxiety, derealization, depersonalization, changes in perception, auditory alterations, and reduced vigilance. Scales will be presented as 100 mm long horizontal lines marked with vertical lines by the participant.

    20 Months

Secondary Outcomes (13)

  • Visual Analog Scales (VAS)

    20 Months

  • Adjective mood rating scale (AMRS)

    20 Months

  • States of consciousness questionnaire (SCQ)

    20 Months

  • Mysticism scale (MS)

    20 Months

  • Eppendorf Schizophrenia Inventory (ESI)

    20 Months

  • +8 more secondary outcomes

Study Arms (2)

Pretreatment with escitalopram

ACTIVE COMPARATOR

Pretreatment with escitalopram (10 mg for 7 days orally, 20 mg for another 7 days orally), followed by administration of psilocybin (25 mg orally) on the study day

Drug: Escitalopram

Pretreatment with placebo oral capsule

PLACEBO COMPARATOR

Pretreatment with placebo, followed by administration of psilocybin (25 mg orally) on the study day

Drug: Placebo oral capsule

Interventions

EscitalopramDRUG

see 'arm description'

Pretreatment with escitalopram
Placebo oral capsuleDRUG

see 'arm description'

Pretreatment with placebo oral capsule

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 25 and 65 years.
  • Understanding of the German language.
  • Understanding the procedures and the risks that are associated with the study.
  • Participants must be willing to adhere to the protocol and sign the consent form.
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
  • Women of childbearing potential must be willing to use double-barrier birth control.

You may not qualify if:

  • Chronic or acute medical condition, including a history of seizures.
  • Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders, and substance abuse).
  • Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
  • Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
  • History of an angle closure glaucoma.
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days).
  • Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known pharmacokinetic or pharmacodynamic interactions with escitalopram).
  • A corrected QT time (QTc), calculated by Bazett's formula, of over 450 milliseconds in males and over 470 milliseconds in females.
  • Tobacco smoking (\>10 cigarettes/day).
  • Consumption of alcoholic drinks (\>10 drinks / week).
  • Bodyweight \< 45 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Clinical Trial Unit

Basel, Canton of Basel-City, 4056, Switzerland

Location

Related Publications (2)

  • Holze F, Becker AM, Kolaczynska KE, Duthaler U, Liechti ME. Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants. Clin Pharmacol Ther. 2023 Apr;113(4):822-831. doi: 10.1002/cpt.2821. Epub 2022 Dec 31.

    PMID: 36507738DERIVED

  • Becker AM, Holze F, Grandinetti T, Klaiber A, Toedtli VE, Kolaczynska KE, Duthaler U, Varghese N, Eckert A, Grunblatt E, Liechti ME. Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Subjects. Clin Pharmacol Ther. 2022 Apr;111(4):886-895. doi: 10.1002/cpt.2487. Epub 2021 Nov 22.

    PMID: 34743319DERIVED

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Matthias E Liechti, MD, MAS

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Pretreatment condition is double-blinded (escitalopram 10 mg x 7 days, then 20 mg orally x 7 days vs. placebo (mannitol) orally x 14 days) On each of the 2 study days, participants will receive psilocybin 25 mg orally (no placebo control on the study days)
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 2-period cross-over, randomized, double-blinded (escitalopram vs. placebo)study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

April 12, 2019

Study Start

July 4, 2019

Primary Completion

November 26, 2020

Study Completion

November 26, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

CH(1)