SuspendedEarly Phase 1

Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

Stopped: Budgeting/funding

United States5 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range15 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 15-17 years old, inclusive * At baseline, meet threshold for Diagnostic and Statistical Manual (DSM-5) criteria for current PTSD as determined by the CAPS-CA. * Medically and neurologically healthy on the basis of physical examination, medical history, and the clinical judgement of the evaluating study medical provider * Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures * If of childbearing potential, must have a negative pregnancy test at study entry and prior to each KAP dosing session, and must agree to use adequate birth control through 10 days after the last KAP dosing session. * Must agree not to participate in any other interventional clinical trials during the duration of the study * Must be willing to comply with all study procedures * A primary parent or guardian is willing to provide informed consent * Are fluent in or predominantly speaking and reading in English Exclusion Criteria: * Caregiver or adolescent is unwilling or unable to give adequate informed consent * Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation. * Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant. * Current diagnosis of or history of a psychotic disorder…

What they're measuring

Summary of Adverse Events Attributable to Ketamine Administration

Timeframe: through the last study visit, up to 10 weeks

Trial details

NCT IDNCT06378528

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09