Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656702
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis ALS with depressed mood The secondary objective is to assess its impact on depression quality of life hopelessness and functional status in this patient population
Detailed Description:
The proposed researchs primary objective is to study the feasibility of psilocybin therapy for patients with ALS with depressed mood The secondary objective is to assess its impact on depression quality of life hopelessness and functional status in this patient population The proposed proof-of-concept interventional trial will use a single-arm design The study will be an open-label trial in a sample of up to 24 treatment-seeking patients with a diagnosis of ALS and depressed mood Participants will complete an 8-week course of study treatment including two psilocybin sessions 15 mg in week 4 and 15 or 25 mg in week 6 with follow-up assessments 1 3 and 6 months after the final psilocybin session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None