Psilocybin for Hospitalized Patients With... — Clinical Trial Details

Phase II interventional

Open-label single-group feasibility study in patients hospitalised for treatment-resistant depression assessing safety, feasibility and preliminary clinical and neurological outcomes of psilocybin-assisted psychotherapy.

Intervention comprises two 25 mg oral psilocybin sessions (week 3 and week 6) with five preparatory psychotherapy sessions (total 7.5 hours) and six integration sessions (total 9 hours), delivered by the same two therapists.

Assessments include questionnaires at regular intervals, EEG before each dosing and during follow-up, urine drug screens and pregnancy tests on dosing mornings, and semi-structured interviews at hospital admission and discharge.

Partners are involved in selected sessions, EEGs and follow-up contacts; outpatient follow-up continues to 12 weeks post-last dose with optional naturalistic follow-up to 1 year.

Study Protocol

Preparation

5 sessions

90 min each

Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium

1. Age 18 years or older.
2. Diagnosis of major depressive disorder (single and recurrent episodes) of moderate to severe degree (MADRS score ≥ 20) according to DSM-5, without psychotic features. Included ICD-11 diagnoses: 6A70.1, 6A70.3, 6A71.1, 6A71.3.
3. Failed to respond to 2 or more antidepressants at minimum effective dose for at least 6 weeks (augmentation counts as a second treatment).
4. Abstinent from alcohol (BAC 0.00) and negative urine drug screen at dosing day.
5. Female subjects provide a negative pregnancy test at dosing day.
6. Medically stable based on labs, history, vitals, and 12-lead ECG at screening (QTcF ≤ 450 ms males, ≤ 470 ms females; PR-interval < 220 ms).
7. A partner willing to participate (cohabiting ≥1 year).

1. Current or past major depressive episode with psychotic features.
2. Psychotic disorder (per MINI 7.0), except substance/medication-induced psychotic disorder limited to acute intoxication.
3. Bipolar disorder (type 1 or 2) on MINI 7.0.
4. Drug or alcohol dependence syndrome on MINI 7.0.
5. Cluster B personality disorder.
6. PTSD on MINI 7.0.
7. Family history (first-degree) of psychosis and/or bipolar disorder.
8. Current active suicidal ideation.
9. Depression secondary to other medical conditions.
10. Medical contraindications (recent stroke or MI <1 year, uncontrolled hypertension >140/90, clinically significant arrhythmia within 1 year, uncontrolled insulin-dependent diabetes, uncontrolled epilepsy).
11. Clinically significant biochemical or ECG abnormalities.
12. Current intake of lithium, disulfiram, MAOIs or inhibitors of UGT1A9/1A10.
13. Prior vagal nerve stimulation or deep brain stimulation device.
14. Women of childbearing potential not using adequate contraception.
15. Pregnant or breastfeeding women.
16. Unable to give informed consent.
17. Enrolled in another trial.

Start: 2024-04-01

End: 2026-12-31

Company

Product

Legal

Psilocybin for Hospitalized Patients With Treatment-resistant Depression (PSIHOS-D)

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators