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
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
Treatments tested in this trial
- psilocybin 25 mg sod
- psilocybin 1 mg sod
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
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