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Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP) | Clinical Trials | Clareo Health

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Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

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

NCT06378528•University of Wisconsin, Madison

View on ClinicalTrials.gov

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

Eligibility

Age

15 - 17 years

Sex

ALL

Healthy Volunteers

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, bipolar disorder, or autism spectrum disorder diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) interview and clinician judgement. No other co-morbid disorders are exclusionary.
•Intellectual disability (IQ\<70) per medical history
•History of moderate to severe substance use disorder, as determined by the KSADS and/or clinician judgement (excluding tobacco), or active substance use (including current alcohol use or positive urine toxicology)
•Any prior exposure to sub-anesthetic doses of ketamine (including prior research or clinical psychiatric treatment with ketamine and/or recreational use)
•Any participant presenting current serious suicide risk, as determined through the KSADS, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts prior to enrollment is not an exclusion.
•Would present a serious risk to others as established through clinical interview and contact with treating physician.
•Current use benzodiazepines, opiates, or lamotrigine, which are hypothesized to interfere with ketamine's mechanism of action
+6 more criteria

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

December 29, 2025

Enrollment

ESTIMATED participants

Conditions

Posttraumatic Stress Disorder

Interventions

Ketamine

DRUG

SmartSleep EEG recording headband

DEVICE

CIH Stepped Care for Co-occurring Chronic Pain and PTSD

NCT06219408

Chronic PainPosttraumatic Stress Disorder

View study

RECRUITINGNA

Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD

NCT07238192

Posttraumatic Stress Disorder (PTSD)Suicidal Ideation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

Inclusion Criteria

Exclusion Criteria

CIH Stepped Care for Co-occurring Chronic Pain and PTSD

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