drugset / Trial / NCT06378528

Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

NCT06378528

Phase 0 Suspended 5 enrolled University of Wisconsin, Madison
NaSingle-groupOpen-labelTreatment

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 accompanied by 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.

Timeline

Start
2026-09
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.5 mg/kg Intravenous