Evaluation of a facilitator training program in a randomized controlled trial of psilocybin treatment for depression.
Nikita Sanati Morel, Dea Siggaard Stenbaek, Johan Lundberg...
https://pubmed.ncbi.nlm.nih.gov/41952163Actively Recruiting
Phase 2
Age: 20Years - 80Years
All Genders
ID06319378
CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial
Led by Section for Affective Disorders; Northern Stockholm Psychiatry · Updated on 2026-04-13
100
Participants Needed
4
Research Sites
N/A
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
Researchers are evaluating the antidepressant effects of a single oral dose of psilocybin in patients aged 20 to 80 who have major depressive disorder related to cancer. This randomized, placebo-controlled trial compares the effects of a 25 mg dose of psilocybin to an active placebo dose of 1 mg. The study focuses on patients with moderate to severe depression occurring after cancer diagnosis, with at least 12 months of expected survival and a willingness to avoid other antidepressant treatments during the study. Participants will receive either a single oral dose of 25 mg psilocybin or 1 mg as an active placebo. The trial includes multiple assessment points, including days 8, 42, 90, and 180 after dosing, to evaluate changes in depressive symptoms and related measures. The study uses a double-blind design to compare the two doses while monitoring safety and adherence. Participants must have a support person to accompany them home after dosing. Throughout the study, participants will attend preparatory and follow-up visits, complete standardized depression questionnaires such as the MADRS, PHQ-9, and others, and undergo clinical evaluations. The primary outcome is the level of depression measured on day 42. Secondary measures assess anxiety, quality of life, and functional status up to day 180. Safety monitoring and adherence checks are included, with the total study participation lasting approximately six months.
CONDITIONS
Brief Title
Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Who Can Participate
Age: 20Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent via minavårdkontakter.se
- Aged 20 to 80 years inclusive at the time of consent
- Able to read, speak, and understand Swedish
- Willing and able to attend all study visits, preparatory and follow-up sessions, and complete evaluations
- Able to swallow capsules
- Women of childbearing potential must agree to use effective birth control during exposure to the study drug
- Diagnosed with malignant neoplasm (ICD-10 codes C00 to C97)
- At least 1 month after cancer diagnosis with an expected life expectancy of at least 12 months
- Physical functioning status of 0 to 2 according to 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 with PHQ-9 score of 10 or higher at screening
- Willing to abstain from other psychotherapeutic or antidepressant treatments during the 180-day study period
- Have an identified support person
- Agree to be driven or accompanied home safely after dosing
You will not qualify if you...
- Last contact with healthcare for cancer monitoring or treatment more than 1 year ago
- Pregnant or nursing women, or those intending pregnancy during the study
- Unwilling or unable to stop formal psychotherapy
- Currently receiving antidepressant drug treatment or certain brain stimulation therapies
- History of deep brain stimulation or vagus nerve stimulation during current episode
- Use of medications that affect UDP or UGT enzymes unless stopped sufficiently before baseline
- Any prior use of psychedelic substances such as psilocybin, LSD, mescaline, DMT, MDMA, or others
- Cancer involving the central nervous system
- Cancer treatment or follow-up incompatible with the study protocol
- Certain cardiovascular conditions including long QT syndrome, coronary artery disease, heart failure, or significant ECG abnormalities
- Elevated blood pressure above study limits
- History of stroke or transient ischemic attack
- Moderate to severe liver impairment
- Uncontrolled epilepsy
- Insulin-dependent diabetes or history of severe hypoglycemia
- Unable or unwilling to suspend sildenafil, tadalafil, or similar medications before dosing
- Positive urine drug test for specified substances except stable benzodiazepines for sleep or anxiety
- Nicotine dependence preventing nicotine abstinence during dosing
- Diagnosis of schizophrenia spectrum, bipolar disorders, antisocial personality disorder, or moderate/severe alcohol or drug use disorders
- Presence of psychiatric or physical conditions judged unsuitable by study physicians
- Suicidal ideation at levels posing serious risk
- Allergy or intolerance to study drug components
- Hepatitis B, C, or HIV infection (unless HIV is treated with undetectable virus)
- Clinically relevant abnormal blood tests except CRP as judged by a study physician
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 180 days
Participants receive a single dose of psilocybin or an active placebo as part of the study treatment for cancer-related major depression.
1 dosing visit and multiple follow-up visits up to Day 180
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
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Research Team
J
Johan Lundberg
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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