Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, a
| Condition(s) | Major Depressive Disorder, Depression, Treatment-Resistant Depression, Mood Disorders |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. |
| Who can participate | Inclusion Criteria: 1. Adults 18 to 65 years old. 2. Must be deemed to have capacity to provide informed consent. 3. Must sign and date the informed consent form. 4. Stated willingness to comply with all study procedures. 5. Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent. 6. Meets DSM-5 criteria for MDD, currently experiencing a Major Depressive Episode (MDE) without psychotic features, as diagnosed by a mood disorder specialist. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI). 7. Current MDE must be moderate to severe, as determined by a MADRS score greater than 21. 8. Have not responded |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University Health Network, Toronto |
| Locations | Toronto, Ontario, Canada |
| Start date | 2024-02-05 |
| NCT ID | NCT06341426 |
| Official listing | https://clinicaltrials.gov/study/NCT06341426 |