Psilocybin for Hospitalized Patients with Treatment-resistant Depression

NCT06378229 | Recruiting Phase 2

• 2 other identifiers: ONZ-2023-01572022-501857-35-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

• Incidence and type of Treatment-Emergent Adverse Events

  The safety of performing psilocybin-assisted psychotherapy in treatment-resistant depression (TRD) in a hospitalized setting. Adverse Events (AEs) will be classified by the clinical team based on severity, whether they are expected or unexpected and causality.

  18 weeks

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Clinician-administered measure of suicidal ideation. Scores range from 0 to 25, with higher scores indicating more severe suicidal ideation.

  18 weeks

Secondary Outcomes (2)

• Recruitment and retention rates.

  8 weeks (end of hospitalization).

• Qualitative data from the semi-structured interviews with the subjects and their partners.

  8 weeks (end of hospitalization).

Other Outcomes (13)

• Montgomery Asberg Depression Rating Scale (MADRS)

  18 weeks (optional up to 58 weeks).

• Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR)

  18 weeks.

• State-Trait Anxiety Inventory (STAI)

  18 weeks.

Study Arms (1)

Open label: full dose Psilocybin

EXPERIMENTAL

2 doses of 25mg Psilocybin, 3 weeks apart (week 3 and week 6), accompanied by 7,5 hours of preparation sessions and 9 hours of integration sessions.

Drug: Psilocybin

Interventions

Psilocybin DRUG

A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (PEX010).

Also known as: PEX010

Open label: full dose Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Diagnosis of major depressive disorder (single and recurrent episodes) of moderate to severe degree (MADRS score ≥ 20) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), without psychotic features. Included ICD-11 diagnoses are ICD-11: 6A70.1, 6A70.3, 6A71.1, 6A71.3.
• Subjects have failed to respond to 2 or more antidepressants prescribed at the minimum effective dose for at least 6 weeks. Augmentation with an add-on treatment counts as a second treatment.
• The subjects are abstinent from alcohol (breathalyzer blood alcohol concentration (BAC) level 0.00) and provide a negative urine drug screen at the dosing day.
• The female subjects provide a negative pregnancy test at the dosing day.
• The subjects must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening.
• \- In 12-lead ECG, QTcF should be ≤ 450 ms for males or ≤ 470 ms for females and PR-interval \< 220 ms at screening.
• A partner is willing to participate in the study (a cohabiting relationship of at least 1 year).

You may not qualify if:

• Currently comorbid or previously diagnosed DSM-5 diagnosis of a
• major depressive episode with psychotic features.
• psychotic disorder (defined as meeting DSM-5 criteria for any psychotic disorder) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
• bipolar disorder (defined as meeting DSM-5 criteria for bipolar type 1 or bipolar type 2) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
• drug or alcohol dependence syndrome (defined as meeting DSM-5 criteria for any dependence syndrome) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
• cluster B personality disorder. Subjects will be screened for the presence of those personality traits by using the NEO-FFI-3.
• PTSD (defined as meeting DSM-5 criteria for PTSD) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
• A family history (first-degree relative) of psychosis and/or bipolar disorder.
• Current active suicidal ideations.
• Depression secondary to other medical conditions.
• Medical diagnosis incompatible with psilocybin treatment:
• Cardiovascular conditions: recent stroke (\< 1 year from signing of ICF), recent myocardial infarction (\< 1 year from signing of ICF), uncontrolled hypertension (blood pressure \> 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
• Uncontrolled insulin-dependent diabetes mellitus.
• Uncontrolled epilepsy.
• Biochemical or electrocardiographic abnormalities determined as clinically significant by a medical doctor. PsiHos-D, Version 2.1 dd. 22/02/2024 page 59 of 114 TMP\_Protocol AGO CTR\_Version 1.0\_Effective Date 2022-07-18

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Filament Health Corp.: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Gilbert Lemmens, Prof. dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cisse Geleyn, dr.

CONTACT

003293328742; cisse.geleyn@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label feasibility study

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 22, 2024
• Study Start: May 21, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1)