Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

Status Not yet recruiting

Clinical Trial Summary

The objectives of this study are to investigate the feasibility, tolerability, and 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 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06378528
Study type	Interventional
Source	University of Wisconsin, Madison
Contact	David Horton
Phone	608-225-0718
Email	david.horton@fammed.wisc.edu
Status	Not yet recruiting
Phase	Early Phase 1
Start date	August 2024
Completion date	August 2025

View Details

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