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Cancer Related Major Depression Treated With a Single Dose of Psilocybin

ConditionMDD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSection for Affective Disorders; Northern Stockholm Psychiatry

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • psilocybin 25 mg sod

    Drug

    psilocybin 25 mg sod

  • psilocybin 1 mg sod

    Drug

    active placebo

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: psilocybin 25 mg (active)Experimental treatment 1 intervention
Group B: psilocybin 1 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MADRS at day 42

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

Time frame
day 42

Secondary outcomes

1

MADRS day 8

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

Time frame
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)

Time frame
Day 42
3

SDS at Day 42

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

Time frame
Day 42
4

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

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

Time frame
Day 8 and 42

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Section for Affective Disorders; Northern Stockholm Psychiatry

Lead sponsor

Uppsala University Hospital

Collaborator

Region Örebro County

Collaborator

Vastra Gotaland Region

Collaborator

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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