NCT06378528

Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

A Preliminary Trial of Safety and Feasibility of Ketamine-assisted Psychotherapy in Adolescents With Posttraumatic Stress-disorder

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 15 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	3 Intravenous ketamine administrations (0.5mg/kg, not to exceed 40mg dose) immediately prior to a psychotherapy session over the span of 6 weeks
DEVICE	SmartSleep EEG recording headband	Participants will complete 7 nights of at-home sleep recordings for exploratory analysis

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-04-22
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study