Actively Recruiting
Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Led by Section for Affective Disorders; Northern Stockholm Psychiatry · Updated on 2026-04-13
100
Participants Needed
4
Research Sites
136 weeks
Total Duration
On this page
Sponsors
S
Section for Affective Disorders; Northern Stockholm Psychiatry
Lead Sponsor
U
Uppsala University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is: The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9) ≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).
CONDITIONS
Official Title
Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Aged 20 to 80 years at time of consent
- Able to read, speak, and understand Swedish
- Able and willing to attend all study visits and complete evaluations
- Able to swallow capsules
- Women of childbearing potential must use effective birth control from screening through Day 8
- Diagnosed with malignant neoplasm (ICD-10 codes C00 to C97)
- At least 1 month after cancer diagnosis and with at least 12 months life expectancy
- Physical functioning status 0-2 (WHO/ECOG)
- Meet ICD-10 criteria for major depressive disorder with a current episode lasting at least 30 days and less than 1 year
- Moderate to severe depression symptoms with PHQ-9 score of 10 or higher at screening
- Willing to abstain from other antidepressant or psychotherapeutic treatments during the 180-day study period
- Have an identified support person
- Agree to be accompanied home by support person after dosing
You will not qualify if you...
- Last cancer-related health care contact more than 1 year ago
- Pregnant or intending to become pregnant or nursing
- Unwilling or unable to stop formal psychotherapy
- Currently on antidepressant drug treatment
- Previous deep brain stimulation or vagus nerve stimulation during current episode
- Currently receiving electroconvulsive therapy or transcranial magnetic stimulation
- Unable or unwilling to stop medications that affect specific enzymes (UDP or UGT modulators) before baseline
- Any lifetime use of psychedelic substances
- Cancer involving the central nervous system
- Cancer treatment regimen incompatible with study protocol
- Certain cardiovascular conditions including congenital long QT syndrome, disabling coronary artery disease, significant ECG abnormalities, artificial heart valve, or other serious cardiovascular history
- Elevated blood pressure above specified thresholds
- History of stroke or transient ischemic attack
- Moderate to severe liver impairment
- Uncontrolled epilepsy
- Insulin-dependent diabetes or history of hypoglycemia requiring intervention
- Unable or unwilling to suspend certain medications prior to dosing
- Positive urine drug test excluding stable prescribed benzodiazepines
- Nicotine dependence preventing abstinence during dosing period
- Diagnosis of schizophrenia spectrum, psychotic disorders, bipolar disorder, antisocial personality disorder
- Moderate or severe alcohol or drug use disorder within past 12 months
- Psychiatric conditions more severe than MDD or incompatible with safe study participation
- Suicidal ideation with high risk as assessed by study physician
- Allergy or intolerance to study drug materials
- Hepatitis B, C, or untreated HIV infection
- Clinically significant abnormal blood test results as judged by study physician
AI-Screening
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Trial Site Locations
Total: 4 locations
1
region Västra Götaland
Gothenburg, Göteborg, Sweden
Actively Recruiting
2
Norra Stockholms Psykiatri
Stockholm, Stockholm County, Sweden
Actively Recruiting
3
Psykiatriska Kliniken, Akademiska Sjukhuset
Uppsala, Uppsala County, Sweden
Actively Recruiting
4
Örebro sjukhus
Örebro, Örebro County, Sweden
Actively Recruiting
Research Team
J
Johan Lundberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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