Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

This interventional trial (n=5) investigates the safety and feasibility of ketamine-assisted psychotherapy in adolescents with posttraumatic stress disorder (PTSD).

Conducted by the University of Wisconsin, Madison, the study aims to enrol adolescents aged 15-17 who meet DSM-5 criteria for current PTSD. Participants will receive three intravenous ketamine administrations immediately prior to psychotherapy sessions over six weeks, followed by integration sessions and at-home sleep recordings.

The primary objective is to characterise the safety and adverse events associated with ketamine administration, while secondary objectives include assessing recruitment feasibility and exploring the impact on PTSD symptom severity.

Recruitment is expected to begin in August 2024, with an estimated completion date of August 2025.

Topic PTSD Adolescence and Psychedelics Safety
Compound Ketamine
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 31 August 2025
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 5
Sex All
Age 15- 17
Therapy Yes

Trial Details

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.

NCT Number NCT06378528

Sponsors & Collaborators

University of Wisconsin-Madison
The Transdisciplinary Center for Research in Psychoactive Substances (TCRPS) was launched at the University of Wisconsin-Madison in 2021.

Data attribution

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