Assessing the subjective intensity of oral... — Clinical Trial Details

Open-label, interventional Phase II pilot in treatment-resistant major depression testing two single oral doses of psilocybin (10 mg and 25 mg) given one week apart in the same participants.

Primary outcome: QIDS measured at baseline, one day and one week post-dose; secondary outcomes include BDI, HAM-D and MADRS. Safety and tolerability were reported and multiple peer-reviewed results publications are linked to the registry record.

1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D)
2. No improvement despite two courses of antidepressant treatment for adequate duration (≥6 weeks) within current episode
3. No magnetic resonance imaging (MRI) contraindications

1. Current or previously diagnosed psychotic disorder
2. Immediate family member with a diagnosed psychotic disorder
3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc)
4. History of suicide attempts
5. History of mania
6. Blood or needle phobia
7. Positive pregnancy test at screening or during the study
8. Current drug or alcohol dependence
9. Allergy to gelatine or lactose
10. Lack of appropriate use of contraception
11. Breastfeeding

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Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: a pilot study (PSILODEP-PILOT)

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Related Publications

Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study

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Psilocybin

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Study Details

Psilocybin with psychological support for treatment-resistant depression: six-month follow-up

Increased nature relatedness and decreased authoritarian political views after psilocybin for treatment-resistant depression

The hidden therapist: evidence for a central role of music in psychedelic therapy

Effects of psilocybin therapy on personality structure

Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression

Increased global integration in the brain after psilocybin therapy for depression

Body mass index (BMI) does not predict responses to psilocybin

Changes in music-evoked emotion and ventral striatal functional connectivity after psilocybin therapy for depression

Increased low-frequency brain responses to music after psilocybin therapy for depression

Brain dynamics predictive of response to psilocybin for treatment-resistant depression

Predicting the outcome of psilocybin treatment for depression from baseline fMRI functional connectivity