Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378528
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Ketamine-assisted Psychotherapy for Adolescent PTSD KAP
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Preliminary Trial of Safety and Feasibility of Ketamine-assisted Psychotherapy in Adolescents With Posttraumatic Stress-disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 objectives of this study are to investigate the feasibility tolerability and preliminary efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder PTSD to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks All participants will complete an initial set of preparatory sessions and each dosing session will be followed by three to six hours of integration sessions Finally participants will complete 7 nights of at-home sleep recordings The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up
Detailed Description:
Primary Objective
Characterize safety and adverse events associated with repeated ketamine-assisted psychotherapy in adolescents with PTSD
Secondary Objectives
Evaluate initial feasibility of recruitment and retention of adolescents with PTSD
Explore potential impacts of ketamine-assisted psychotherapy on PTSD symptom severity at follow-up
Characterize safety and adverse events associated with repeated ketamine-assisted psychotherapy in adolescents with PTSD
Secondary Objectives
Evaluate initial feasibility of recruitment and retention of adolescents with PTSD
Explore potential impacts of ketamine-assisted psychotherapy on PTSD symptom severity at follow-up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version Jan 2024 | OTHER | None | None |
| A538900 | OTHER | UW Madison | None |