Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression

Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: A Pilot Study - PSILODEP-pilot

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003196-35-GB

Enrollment

Registered

2015-07-01

Start date

2015-01-07

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder MedDRA version: 18.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: Psilocybin Product Code: Psilocybin Pharmaceutical Form: Capsule INN or Proposed INN: Psilocybin CAS Number: 520-52-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Treatment resistant major depressive disorder, DSM-IV (i.e. depression which has failed to respond to at least 2 courses of antidepressant treatment of different class) 18+ yrs of age Males and females 17+ on the HAM-D Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Current or previously diagnosed psychotic disorder. 2. Immediate family member with a diagnosed psychotic disorder. 3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc). 4. History of suicide attempts. 5. History of mania. 6. Blood or needle phobia. 7. Positive pregnancy test at screening or during the study. 8. Current drug or alcohol dependence.

Design outcomes

Primary

Measure	Time frame
Main Objective: How sensitive are patients with depression to the subjective effects of psilocybin?; Secondary Objective: Can we identify changes in brain activity pre (6 days pre session 1) and post (next day after session 2) treatment using functional MRI? ;Primary end point(s): Ratings of the intensity of the subjective effects of psilocybin ;Timepoint(s) of evaluation of this end point: Peak drug effects	—

Measure

Time frame

Main Objective: How sensitive are patients with depression to the subjective effects of psilocybin?; Secondary Objective: Can we identify changes in brain activity pre (6 days pre session 1) and post (next day after session 2) treatment using functional MRI? ;Primary end point(s): Ratings of the intensity of the subjective effects of psilocybin ;Timepoint(s) of evaluation of this end point: Peak drug effects

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in brain activity, i.e. blood flow and resting-state functional connectivity, post versus pre treatment. ;Timepoint(s) of evaluation of this end point: One day post-second treatment session ('post') versus 6 days prior to first session ('pre').	—

Countries

United Kingdom

Contacts

Public ContactCarhart-Harris, Robin

Imperial College London

r.carhart-harris@imperial.ac.uk02075946550

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026