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Could inflammation predict who benefits from magic mushroom therapy?
NCT ID NCT07164755
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study examines blood samples from 46 people with treatment-resistant depression who took psilocybin in a previous trial. Researchers will measure markers of inflammation (cytokines and mRNA) to see if they relate to how well the treatment worked. The goal is to understand whether inflammation levels before or after treatment can predict who gets better, which could help personalize psychedelic therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors predict who will benefit from psilocybin therapy and point toward new ways to treat depression by targeting inflammation.
- What could go wrong
- This is a small, observational analysis of existing samples, not a new treatment trial. It may not find clear links between inflammation and depression outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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46 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with treatment-resistant depression, recruited in the UK
- Ages
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25 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Fluent in the English language * Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for current single or recurrent episodes of MDD of at least moderate severity but without psychotic features, as defined on the MINI 7.0. * 17-item HAM-D score ≥ 14. * Have failed to respond to 2 or more antidepressants prescribed at the minimum effective dose for at least 6 weeks OR at least 1 antidepressant prescribed at the minimum effective dose for at least 6 weeks AND a course of evidence-based psychotherapy given for at least 6 sessions. * For those aged ≥ 60 years, the first episode of depression must have started prior to their 60th birthday. Exclusion Criteria: Diagnosis of bipolar disorder (defined as meeting DSM-5 criteria for bipolar 1 or bipolar 2) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. Diagnosis of psychotic disorder (defined as meeting DSM-5 criteria for any psychotic disorder) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. Diagnosis of drug or alcohol dependence syndrome (defined as meeting DSM-5 criteria for any dependence syndrome) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. Diagnosis of any personality disorder (defined as meeting DSM-5 criteria for any personality disorder) based on clinical interview and the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist. Personal history of a ≥ 1 suicide attempt in the past year requiring hospitalization, defined using the CSSRS (Q6 (past year) = "y") and confirmation at clinical interview with a psychiatrist. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin. Depression secondary to other medical conditions Medical diagnosis incompatible with psilocybin treatment Inability to provide a screening blood sample, urine sample or electrocardiogram. Biochemical abnormalities (defined as falling outside the normal reference range) as evaluated by a full blood count, full biochemistry profile and thyroid function tests. Biochemical abnormalities must also be determined as clinically significant by a medical doctor to fulfil the criterion for exclusion. Electrocardiographic abnormalities, defined as any abnormality that is not normal sinus rhythm and determined as clinically significant by a medical doctor. Women of child bearing potential not using adequate contraception. Pregnant or breast-feeding women. Those unable to give informed consent. Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held. Those enrolled in another drug trial Hypersensitivity to the IMP or to any of the excipients or placebo
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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King's College London Institute of Psychiatry, Psychology and Neuroscience
London, SE5 8AF, United Kingdom
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