Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378229
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-14
Brief Title:
Psilocybin for Hospitalized Patients with Treatment-resistant Depression
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression an Open-label Feasibility Study with an Experiential and Systemic Focus
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSIHOS-D
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
Detailed Description:
The proposed study will assess the safety feasibility preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients with treatment-resistant depression
Screening after signing the ICF is done in patients newly admitted to the psychiatric service of Ghent University Hospital or patients referred for hospitalization through the outpatient clinic of the psychiatric service of Ghent University Hospital Involved patients are hospitalized at the Anxiety Compulsion and Mood Unit for 8 weeks They will receive add-on treatment with psilocybin-supported psychotherapy in addition to standard treatment daily group therapies mainly non-verbal and activating This consists of a preparatory phase 4 sessions of 15 hours before the first psilocybin session and 1 session of 15 hours before the second psilocybin session the psilocybin sessions themselves 2 sessions week 3 and week 6 and an integration phase 3 sessions of 15 hours after each psilocybin session All sessions occur with the same 2 therapists throughout the entire course Therapists are trained to provide experiential and systemic psychotherapeutic interventions
After hospitalization weekly outpatient follow-up consultations continue until 12 weeks after the last psilocybin session Subsequently patients may still agree to a prospective observational and naturalistic follow-up until 1 year after the last psilocybin session during which they will be called monthly by a psychiatrist from the research team to inquire about current mental status and any therapies undertaken in the interim
During the study patients are required to fill out questionnaires at regular intervals Video-recordings will be made of certain parts of the preparation and integration sessions for analysis with the client experience scale EXP The morning of each psilocybin session female patients must provide a blood sample for a pregnancy test The morning of each psilocybin session all patients must provide a urine sample for toxicology screening EEGs are also taken from patients the day before each psilocybin session the morning of the first integration session after each psilocybin session and 12 weeks after the last psilocybin session at the last outpatient consultation At the start and at the end of the hospitalization phase a semi-structured interview will be conducted with the patient to gauge expectations on the one hand and experiences on the other
Throughout the study the patients partner will be involved The partner must complete a number of questionnaires at baseline and throughout the study and will have to be present at 3 EEGs In addition the partner will also participate in 1 preparatory session and 2 integration sessions The partner will also be given the opportunity to spend the night of a psilocybin session with the patient in the hospital rooming-in At the start and at the end of the hospitalization phase a semi-structured interview will be conducted with the partner to gauge expectations on the one hand and experiences on the other
Screening after signing the ICF is done in patients newly admitted to the psychiatric service of Ghent University Hospital or patients referred for hospitalization through the outpatient clinic of the psychiatric service of Ghent University Hospital Involved patients are hospitalized at the Anxiety Compulsion and Mood Unit for 8 weeks They will receive add-on treatment with psilocybin-supported psychotherapy in addition to standard treatment daily group therapies mainly non-verbal and activating This consists of a preparatory phase 4 sessions of 15 hours before the first psilocybin session and 1 session of 15 hours before the second psilocybin session the psilocybin sessions themselves 2 sessions week 3 and week 6 and an integration phase 3 sessions of 15 hours after each psilocybin session All sessions occur with the same 2 therapists throughout the entire course Therapists are trained to provide experiential and systemic psychotherapeutic interventions
After hospitalization weekly outpatient follow-up consultations continue until 12 weeks after the last psilocybin session Subsequently patients may still agree to a prospective observational and naturalistic follow-up until 1 year after the last psilocybin session during which they will be called monthly by a psychiatrist from the research team to inquire about current mental status and any therapies undertaken in the interim
During the study patients are required to fill out questionnaires at regular intervals Video-recordings will be made of certain parts of the preparation and integration sessions for analysis with the client experience scale EXP The morning of each psilocybin session female patients must provide a blood sample for a pregnancy test The morning of each psilocybin session all patients must provide a urine sample for toxicology screening EEGs are also taken from patients the day before each psilocybin session the morning of the first integration session after each psilocybin session and 12 weeks after the last psilocybin session at the last outpatient consultation At the start and at the end of the hospitalization phase a semi-structured interview will be conducted with the patient to gauge expectations on the one hand and experiences on the other
Throughout the study the patients partner will be involved The partner must complete a number of questionnaires at baseline and throughout the study and will have to be present at 3 EEGs In addition the partner will also participate in 1 preparatory session and 2 integration sessions The partner will also be given the opportunity to spend the night of a psilocybin session with the patient in the hospital rooming-in At the start and at the end of the hospitalization phase a semi-structured interview will be conducted with the partner to gauge expectations on the one hand and experiences on the other
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501857-35-00 | CTIS | None | None |