AzTrials
AzTrials

MDDPhase 2CAPSINCT06319378

Cancer Related Major Depression Treated With a Single Dose of Psilocybin

A Phase 2 study testing psilocybin 25 mg sod and psilocybin 1 mg sod in people with MDD, run by Section for Affective Disorders; Northern Stockholm Psychiatry at 4 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
MDD
What is being tested?
psilocybin 25 mg sod and psilocybin 1 mg sod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesSweden
Study dates
19 Apr 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • signed informed consent via minavårdkontakter.se
  • Are 20 to 80 (inclusive) years old at the time of signed informed consent
  • Are able to read, speak, and understand Swedish
  • Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
  • Are able to swallow capsules
  • Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of exposure to the Investigational Product, from Screening through the Day 8.
Show all 14Show fewer
  • A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)
  • ≥1 month after cancer diagnosis and ≥ 12 months of life expectancy at time of inclusion
  • physical functioning performance status 0-2 (World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG))
  • Meet ICD-10 criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 30-day duration at the time of the Screening less than 1 year at time of Screening
  • Have moderate-severe depression symptoms at Screening, as defined by a Screening PHQ-9 total score ≥ 10.
  • Are willing to abstain from other psychotherapeutic or antidepressant treatments during the study period (180 days; wash out time 5 half-lives). Note, if antidepressant treatment becomes needed as determined by the study physician this will be supported by the study personnel.
  • Have an identified support person.
  • Agree to be driven/accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing

Who cannot join

  • Individuals not eligible to be randomized in this protocol are those who meet any of the following criteria:
  • Last contact with health care due to cancer monitoring or treatment >1 year ago.
  • Women who are pregnant, as indicated by a positive urine pregnancy test at Screening or Baseline. Women who intend to become pregnant during the study or who are currently nursing.
  • Unwilling or unable to discontinue formal psychotherapy
  • Ongoing antidepressant drug treatment. No interruption of ongoing antidepressant treatment will be done on the initiation of the study personnel. Patients will be encouraged to discuss any interruption with their responsible clinical physician.
  • Have previously during the current episode received the following non-medication treatments: deep brain stimulation (DBS); vagus nerve stimulation (VNS)
Show all 47Show fewer
  • Currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
  • Unable or unwilling to discontinue any current medications that are known uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzyme modulators (eg valproate) Note: Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug plus one week at the time of Baseline. See Appendix A for a full list of prohibited medications.
  • Report psychedelic substances use ever
  • o Note: Psychedelic substances include psilocybin, Lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 3,4-methylenedioxy- methamphetamine (MDMA) or other psychedelics.
  • Cancer at time of inclusion involving the Central Nervous System (CNS) (as determined by a clinical examination or Magnetic Resonance Imaging (MRI))
  • Cancer treatment/follow up regime determined to be incompatible with the CAPSI protocol (eg due to time lines, interaction between cancer treatment and psilocybin 25 mg or 1 mg exposure).
  • Have any of the following cardiovascular conditions:
  • congenital long QT syndrome (prior diagnosis),
  • any of the following if disabling physical exercise similar to walking two stairs without pause: coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure
  • a clinically significant Screening Electro Cardio-Graphy (ECG) abnormality (e.g., atrial fibrillation);
  • artificial heart valve; or
  • any other significant current or history of cardiovascular condition, based on the clinical judgment of study physician, that would make a participant unsuitable for the study
  • At Screening or Baseline have elevated blood pressure as defined as:
  • Screening blood pressure Systolic Blood Pressure >150 mmHg or Diastolic Blood Pressure > 95 mmHg on three separate readings; or
  • o Baseline blood pressure SBP >160 mmHg or DBP > 100 mmHg on three separate readings
  • Have a history of stroke or Transient Ischemic Attack (TIA)
  • Have moderate to severe hepatic impairment, as indexed by a Child-Pugh score ≥ 7
  • Have uncontrolled epilepsy
  • Have insulin-dependent diabetes
  • Note: Participants who are taking oral hypoglycemic agent and have a history of hypoglycemia requiring medical intervention will be excluded
  • Are unable or unwilling to adhere to the following medication requirements:
  • Agree to suspend sildenafil (Viagra®), tadalafil, or similar medications at least 72 hours prior to dosing
  • Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC). Exceptions are made for prescribed Benzodiazepines (stable dose for sleep or anxiety).
  • o Note: Benzodiazepine medications for sleep and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications Note: Participants using cannabis, including legal cannabis, for any purposes will be excluded Note: Participants who are taking prescription maintenance methadone or buprenorphine naloxone will be excluded Note: Prescription opiates must have been stopped at least 5x the elimination half- life of the specific drug at the time of inclusion, as confirmed with a negative urine drug screen.
  • Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period
  • Meet International Classification of Diseases version 10 (ICD-10) criteria for schizophrenia spectrum or other psychotic disorders, including MDD with psychotic features (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder, Bipolar II Disorder.
  • Note: Participants with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders will be excluded
  • Meet ICD-10 criteria for antisocial personality disorder
  • Meet ICD-10 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine) Note: Participants with a diagnosis of alcohol or drug use disorder within the past 12 months will be excluded
  • Have the presence of any psychiatric condition or symptom judged by the PI (or designee) to be a more significant clinical problem than MDD for the participant.
  • Have a first-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition).
  • Have a psychiatric condition judged to be incompatible with establishment of rapport with the Facilitators or safe exposure to psilocybin
  • Report the following suicidal ideation or suicidal thoughts defined as
  • Have a score of ≥ 5 on Item 10 (suicidal thoughts) on MADRS at Screening or Baseline; or
  • Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior at any time prior to randomization
  • Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
  • Have any physical or psychological symptom, medication or other relevant finding at Screening or Baseline, based on the clinical judgment of clinical/medical study personnel, that would make a participant unsuitable for the study.
  • Have an allergy or intolerance to any of the materials contained in either drug product
  • Have Hepatitis B, C or HIV (HIV only allowed if on treatment and non-detectable virus
  • concentrations)
  • Have one or more clinically relevant pathological blood test results (as determined by a study physician; with the exception of CRP).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Johan Lundberg contact

0812340000

johan.lundberg@ki.se

Sweden4 sites, 4 recruiting

  • region Västra Götaland

    Gothenburg, Göteborg

    Helena Werin Sjögren, MD, helena.werin.sjogren@vgregion.se

    Mikael Landén, MD PhD

    Recruiting

  • Örebro sjukhus

    Örebro, Örebro County

    Axel Nordenskjöld, MD PhD

    Evana Lopez, MD, evana.lopez@ki.se

    Recruiting

  • Norra Stockholms Psykiatri

    Stockholm, Stockholm County

    Evana Lopez, MD, evana.lopez@ki.se

    Carl-Johan Ekman, PhD

    Recruiting

  • Psykiatriska Kliniken, Akademiska Sjukhuset

    Uppsala, Uppsala County

    Evana Lopez, evana.lopez@ki.se

    robert Bodén, MD PhD

    Recruiting

Other trials in Sweden

About this study

Official title: CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

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
MDD
Being tested
psilocybin 25 mg sod, psilocybin 1 mg sod
Keywords
malignant neoplasm
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psilocybin 25 mg sodDrug

    psilocybin 25 mg sod

  • psilocybin 1 mg sodDrug

    active placebo

Study groups in NCT06319378
Study groupRoleWhat they receive
psilocybin 25 mg (active)ExperimentalNot described
Receives: Drug: psilocybin 25 mg sod
psilocybin 1 mgActive comparatorNot described
Receives: Drug: psilocybin 1 mg sod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MADRS at day 42

    Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

    Measured: day 42

Secondary outcomes (16)

  1. MADRS day 8

    Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

    Measured: day 8

  2. MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1)

    Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)

    Measured: Day 42

  3. SDS at Day 42

    Sheehan Disability Scale (SDS) (0-10, smaller equals better)

    Measured: Day 42

  4. CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6)

    Clinical Global Impression (CGI), (1-7, smaller equals better)

    Measured: Day 8 and 42

  5. EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6)

    Euroquol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

    Measured: Day 8 and 42

  6. AQOL-6D at Day 42 (ANCOVA x1)

    Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)

    Measured: Day 42

  7. MADRS at Day 90 and Day 180 (ANCOVA x2)

    Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

    Measured: Day 90 and Day 180

  8. MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1)

    Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)

    Measured: between Day 43 and Day 180

  9. SDS at Day 180 (ANCOVA x3)

    Sheehan Disability Scale (SDS) (0-10, smaller equals better)

    Measured: Day 180

  10. GAD-7 at Day 180 (ANCOVA x3)

    General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)

    Measured: Day 180

  11. HADS at Day 180 (ANCOVA x3)

    Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)

    Measured: Day 180

  12. CGI at Day 90 and Day 180 (ANCOVA x6)

    Clinical Global Impression (CGI), (1-7, smaller equals better)

    Measured: Day 90 and Day 180

  13. EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6)

    Euroqol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

    Measured: Day 90 and Day 180

  14. AQOL-6D at Day 90 and Day 180 (ANCOVA x2)

    Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)

    Measured: Day 90 and Day 180

  15. GAD-7 at Day 42

    General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)

    Measured: Day 42

  16. HADS at Day 42

    Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)

    Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start19 Apr 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial, active placebo, randomization ratio 2:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06319378
Sponsor's protocol ID
CAPSI no 2 date 231024
Other IDs
2023-505532-35-00, 2023
Acronym
CAPSI
Status last verified
Apr 2026
First submitted
8 Nov 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Morel NS, Stenbaek DS, Lundberg J, Beckman M. Evaluation of a facilitator training program in a randomized controlled trial of psilocybin treatment for depression. BMC Med Educ. 2026 Apr 9;26(1):635. doi: 10.1186/s12909-026-09124-8.

    PubMed 41952163

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing psilocybin 25 mg sod and psilocybin 1 mg sod in people with MDD, run by Section for Affective Disorders; Northern Stockholm Psychiatry at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johan Lundberg (0812340000, johan.lundberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MADRS at day 42 (time frame: day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06319378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in