Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

NCT06378528 | Suspended Early Phase 1 FDA Drug

• 3 other identifiers: 2023-1706Protocol Version 11/14/25A538900
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Summary of Adverse Events Attributable to Ketamine Administration

  Degree of adverse effects (AEs) attributable to ketamine administration as categorized according to the abbreviated (six-item) Clinician-Administered Dissociative States Scale (CADSS-6), which assesses situation-dependent dissociative states, and the Systematic Assessment for Treatment Emergent Events (SAFTEE-GI), which uses a standardized general (SAFTEE-GI) inquiry of physical/health problems and possible treatment-emergent side effects. The SAFTEE-GI will be administered during the preparatory period, at every KAP dosing session, integration, and endpoint assessment visit, the CADSS-6 will be administered at every KAP dosing session and during each integration period. Reported here are a list of AEs attributed to KAP Administration with count of participants experiencing them.

  through the last study visit, up to 10 weeks

Secondary Outcomes (2)

• Number of Participants Adhering to the Study Protocol

  up to 10 weeks

• Number of Visits Completed Throughout the Study Duration

  up to 10 weeks

Other Outcomes (2)

• Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA)

  baseline and 1 month follow up (at up to 10 weeks on study)

• Exploratory Measurements: Change waveform recorded with Philips SmartSleep headband, measured in Hz

  7 consecutive nights surrounding the first KAP session, during study week 2

Study Arms (1)

Adolescents with Severe PTSD

EXPERIMENTAL

Drug: Ketamine; Device: SmartSleep EEG recording headband

Interventions

Ketamine DRUG

3 Intravenous ketamine administrations (0.5mg/kg, not to exceed 40mg dose) immediately prior to a psychotherapy session over the span of 6 weeks

Also known as: Ketamine Assisted Psychotherapy

Adolescents with Severe PTSD

SmartSleep EEG recording headband DEVICE

Participants will complete 7 nights of at-home sleep recordings for exploratory analysis

Adolescents with Severe PTSD

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)
• 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
• High blood pressure (BP) at the time of screening, defined by the Centers for Disease Control and Prevention (CDC) to be BP greater than 130/80.
• Persons who have previously received ketamine therapeutically or taken it recreationally.
• Are pregnant, nursing, or are able to become pregnant and are not practicing an effective means of birth control.
• Persons who are known to have a hypersensitivity to ketamine
• Participants that are deemed not to be medically and neurologically healthy on the basis of physical examination, medical history, and the clinical judgement of the Study Medical Provider or qualified designee in order to participate.
• Examples of medical rule-outs include but are not limited to: unstable hypertension, recent severe neurologic injury, a history or current signs/symptoms of liver or renal insufficiency, and current diagnoses of cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disorders that are deemed clinically significant based on investigator judgement.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Christopher Nicholas, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group, open label, pilot study

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)