Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinRecruiting

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

Open-label feasibility study (n=100) of two 25 mg psilocybin sessions with preparatory and integration psychotherapy for hospitalized patients with treatment-resistant depression.

Target Enrollment
100 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

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

Dosing

2 sessions

Integration

6 sessions
90 min each

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Two 25 mg psilocybin dosing sessions (week 3 and week 6) with preparatory and integration psychotherapy during an 8-week hospitalisation.

Interventions

  • Psilocybin25 mg
    via Oral• two sessions• 2 doses total

    Capsule PEX010; doses given 3 weeks apart (week 3 and week 6) alongside psychotherapy.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Study Details

Locations

Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium

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