NCT07164755Active, not recruiting
Measurement of Serum Inflammatory Markers in Patients Treatment-resistant Depression Given Psilocybin
Measurement of Serum Cytokine Levels in Samples Collected as Part of a Clinical Trial of Psilocybin for Treatment-resistant Depression.
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
About one in three people with major depression respond poorly to standard antidepressant treatments. This kind of depression is called treatment-resistant depression, and it can lead to long-term disability, financial challenges, and a higher risk of suicide. Psilocybin-a compound found in certain mushrooms-has shown early promise as a new treatment for this difficult-to-treat depression. Scientists believe it works by affecting a specific brain receptor (called 5-HT2A), which helps the brain become more flexible and adaptable. But there's another possible mechanism of psilocybin that hasn't been studied much: its ability to influence the immune system. Recent research suggests that inflammation in the body might play a role in depression, especially when treatments don't work. High levels of certain inflammatory markers (called cytokines) are linked to poor response to antidepressants, while lower levels are tied to feeling better. Psilocybin may help reduce this inflammation, which could be part of why it helps some people feel better. Still, we don't fully understand how a person's inflammation levels before treatment, and how those levels change afterward, relate to how well psilocybin works. Figuring this out could help doctors better match patients to psychedelic therapy and discover new ways to treat depression. In this study, blood samples from a recent study (called the PsiDeR trial) that tested psilocybin in people with treatment-resistant depression will be analyzed. Cytokine levels in these blood samples, as well as levels of another type of molecule linked to inflammation, called mRNA, will be measured.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 2 Sept 2025
- Start date
- 21 Jun 2021
- Primary completion date
- Sept 2026
- Lead sponsor
- King's College London
- Diseases
- Depression
- NCT number
- NCT07164755
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 21 Jun 2021 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those enrolled in another drug trial
Other illness
- 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.
- Depression secondary to other medical conditions
- Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
- Hypersensitivity to the IMP or to any of the excipients or placebo
Lab values
- 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.
Other
- Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- Medical diagnosis incompatible with psilocybin treatment
- Inability to provide a screening blood sample, urine sample or electrocardiogram.
- 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.
Who the study is looking for
- 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.
Age in the registry: 25 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College London Institute of Psychiatry, Psychology and Neuroscience Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.