Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303739
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-27
Brief Title:
Psilocybin-Assisted Therapy in Treatment-Resistant Depression
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression TRD A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression The main questions this study aims to answer are
Does psilocybin with assisted therapy help improve symptoms for people with depression
How long do the effects of this treatment last
Participants will
Take part in a couple of screening and preparation visits
Be given psilocybin in one or two treatment sessions
Attend a series of follow-up sessions over the following year
Complete forms and surveys to test how their symptoms have changed and what they thought of their experience
Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants
Does psilocybin with assisted therapy help improve symptoms for people with depression
How long do the effects of this treatment last
Participants will
Take part in a couple of screening and preparation visits
Be given psilocybin in one or two treatment sessions
Attend a series of follow-up sessions over the following year
Complete forms and surveys to test how their symptoms have changed and what they thought of their experience
Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants
Detailed Description:
Major depressive disorder MDD ranks fourth in global disease burden and has significant morbidity mortality societal and financial costs However few adequate and effective treatments exist with 60 of MDD patients not responding sufficiently to an initial oral antidepressant treatment These patients who experience treatment resistant depression TRD defined as an intolerance or lack of response to two antidepressants of different classes have limited treatment options beyond the antidepressant treatments that often yield insufficient results or relapse Psilocybin a novel treatment has been found to relieve symptoms of TRD but there are limited studies on specific dosing and long term treatment follow-up In this study the investigators will look closer at the effectiveness of one treatment with psilocybin versus two treatments with psilocybin as well as the long term effectiveness over the first 12 months after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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