CompletedPhase 2

Psilocybin for Treatment-Resistant Depression

Canada30 participantsStarted 2021-11-19

Plain-language summary

The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve. This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants' depressive symptoms and side effects will also be measured during the study.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Over the age of 18 years and under the age of 65;
✓. Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider;
✓. Experiencing a major depressive episode (MDE) without psychotic features as defined and operationalized in the DSM-5, where the duration of the current episode is at least 3 months;
✓. Have failed to respond to an adequate dose and duration of at least two guideline-concordant pharmacological treatments for the current MDE, as determined by the Massachusetts General Hospital-Antidepressant Treatment History Questionnaire; and
✓. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

What they're measuring

Feasibility of the study based on participant retention

Timeframe: Up to 24 weeks

Feasibility of the study based on suicidal ideation and behaviour scores

Timeframe: Up to 24 weeks

Feasibility of the study based on adverse events

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT05029466

SponsorBrain and Cognition Discovery Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-22

View on ClinicalTrials.gov More Treatment Resistant Depression trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Over the age of 18 years and under the age of 65;
✓. Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider;
✓. Experiencing a major depressive episode (MDE) without psychotic features as defined and operationalized in the DSM-5, where the duration of the current episode is at least 3 months;
✓. Have failed to respond to an adequate dose and duration of at least two guideline-concordant pharmacological treatments for the current MDE, as determined by the Massachusetts General Hospital-Antidepressant Treatment History Questionnaire; and
✓. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.