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Studies how psilocybin may ease depression, with and without pimavanserin

Studies psilocybin with pimavanserin or placebo in adults with depression.

Key facts

Who runs it
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Where
Barcelona, SpainSee the site
Registry title
Antidepressant effects of psilocybin without the psychedelic serotonin experience: A dimensional approach using functional neuroimaging.
Status
Not yet recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
1 Jan 2026
Expected to end
1 Dec 2027
Type of study
Interventional
Record updated
31 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression without psychosis, who still have a current depressive episode after at least one earlier antidepressant did not work well enough.

Age
18 to 65 years
Sex
Men and women
Disease stage
Non-psychotic major depressive disorder (DSM-5) with a current major depressive episode and a score of 14 or more on the 24-HDRS
Earlier treatment
At least one earlier adequate antidepressant attempt that did not work. No electroconvulsive therapy, esketamine or experimental medicines or interventions in the last month. No lifetime use of serotonergic psychedelic drugs.

Main reasons for not taking part

  • Another severe mental disorder or substance use disorder (nicotine dependence is allowed)
  • Pregnancy or breastfeeding
  • Heart rhythm problems or long QTc on the heart test
  • Active suicidal thoughts
  • A first-degree relative with a psychotic disorder

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Adults diagnosed with a non-psychotic MDD according to DSM-5 criteria and who are experiencing a current major depressive episode resistant to at least one previous adequate attempt of antidepressant treatment
  • Patients will be men and women aged between 18 and 65 years
  • Patients with a score of ≥ 14 on the 24-HDRS
  • Individuals who have the legal capacity to personally provide informed consent and who do so

Who cannot take part

  • In the case of individuals capable of becoming pregnant, a) a negative pregnancy test will be required during the week prior to recruitment and again on the day of recruitment, and b) the use of two highly effective contraceptive methods, one of which must be a barrier method, throughout participation in the study
  • Current use of other substances (medications or drugs) that may interfere with the study products
  • Current or past comorbidity with another severe mental disorder or substance use disorder, except for nicotine dependence
  • Clinically relevant impairment of renal or hepatic function
  • A first-degree relative with a history of any psychotic disorder
  • Current or past presence of serious medical conditions that pose a health risk or that interfere, either directly or due to their treatment, with the interpretation of the study
  • History of electroconvulsive therapy, esketamine, or experimental medications or interventions in the last month, along with lifetime use of serotonergic psychedelic drugs
  • Subjects with a history of rhythm disorders or other cardiac conditions, with baseline QTc values >450 ms (men) or >470 ms (women), or with electrolyte abnormalities of any cause
  • Subjects who are taking concomitant medications during the study with a known risk of QTc prolongation (e.g., macrolides, fluoroquinolones, antipsychotics, ondansetron, droperidol, amiodarone, sotalol, quinidine, or others); any concomitant medication taken by the subjects will be verified for this purpose by consulting the corresponding Summary of Product Characteristics (SmPC)
  • Contraindication for psilocybin or pimavanserin
  • Contraindication for magnetic resonance imaging (MRI)
  • Pregnancy or breastfeeding
  • Anticipated lack of availability to attend all study visits and procedures
  • Active suicidal ideation

Where in Spain

  • Hospital de la Santa Creu i Sant PauBarcelona, SpainNot yet recruiting

About the trial

What the trial wants to find out

Evaluate which changes in resting-state network functional connectivity (rsNFC) induced by psilocybin are associated with the psychedelic experience by comparing functional magnetic resonance imaging (fMRI) data from patients with major depressive disorder (MDD) treated with psilocybin + pimavanserin and those treated with psilocybin + placebo across scans 1, 2, and 3.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Antidepressant effects of psilocybin in the absence of serotoninergic psychedelic experience: a dimensional functional neuroimaging approach
Plain-language title
Studies how psilocybin may ease depression, with and without pimavanserinGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
31 July 2026