Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

March 23, 2026 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sara Heyn, JD, PhD
  • Phone Number: 303-296-2116
  • Email: sheyn@wisc.edu

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adolescents with Severe PTSD
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
Other Names:
  • Ketamine Assisted Psychotherapy
Device: SmartSleep EEG recording headband
Participants will complete 7 nights of at-home sleep recordings for exploratory analysis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Summary of Adverse Events Attributable to Ketamine Administration
Time Frame: through the last study visit, up to 10 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Adhering to the Study Protocol
Time Frame: up to 10 weeks
Study protocol adherence for preparation, dosing, and follow-up visits.
up to 10 weeks
Number of Visits Completed Throughout the Study Duration
Time Frame: up to 10 weeks
There are approximately 16 study visits from screening through one month follow up.
up to 10 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA)
Time Frame: baseline and 1 month follow up (at up to 10 weeks on study)
The CAPS-CA is a well-validated instrument in adolescent populations and is used often in pediatric clinical trials. This outcome will assess the current severity of overall PTSD symptomatology. Assessments of this endpoint will occur prior to any preparatory sessions and again at a 1-month follow-up. Scores indicate a PTSD severity rating from 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (extreme).
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
Time Frame: 7 consecutive nights surrounding the first KAP session, during study week 2
During the first KAP session week, sleep will be recorded for seven nights (3 nights prior to the KAP session, night of KAP session, and 3 nights after KAP session) using the Philips SmartSleep recording headband. The SmartSleep device collects real-time EEG data. The EEG signals are acquired at 1000 Hz, high-pass filtered using a single pole filter (0.3 Hz cutoff frequency), notch filtered at 50 Hz and 60 Hz to remove power-line noise, and down-sampled to 250 Hz for real-time, onboard sleep scoring.
7 consecutive nights surrounding the first KAP session, during study week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Nicholas, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-1706
  • A538900 (Other Identifier: UW- Madison)
  • Protocol Version 11/14/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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