Posttraumatic Stress DisorderEarly Phase 1NCT06378528
Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)
A Early Phase 1 study testing Ketamine and SmartSleep EEG recording headband in people with Posttraumatic Stress Disorder, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Ketamine and SmartSleep EEG recording headband
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
About this study
Official title: 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.
Read the 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
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Ketamine, SmartSleep EEG recording headband
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine Assisted Psychotherapy
3 Intravenous ketamine administrations (0.5mg/kg, not to exceed 40mg dose) immediately prior to a psychotherapy session over the span of 6 weeks
SmartSleep EEG recording headbandDevice
Participants will complete 7 nights of at-home sleep recordings for exploratory analysis
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with Severe PTSD | Experimental | Not described Receives: Drug: Ketamine; Device: SmartSleep EEG recording headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through the last study visit, up to 10 weeks
Secondary outcomes (2)
Number of Participants Adhering to the Study Protocol
Study protocol adherence for preparation, dosing, and follow-up visits.
Measured: up to 10 weeks
Number of Visits Completed Throughout the Study Duration
There are approximately 16 study visits from screening through one month follow up.
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: Budgeting/funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, open label, pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Nicholas, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378528
- Sponsor's protocol ID
- 2023-1706
- Other IDs
- Protocol Version 11/14/25, A538900
- Status last verified
- Nov 2026
- First submitted
- 17 Apr 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Trial of Safety and Feasibility of Ketamine-assisted Psychotherapy in Adolescents With Posttraumatic Stress-disorder
- ClinicalTrials.gov ID
- NCT06378528
- Acronym / sponsor ID
- 2023-1706
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Budgeting/funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, open label, pilot study
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Severe PTSD | Experimental | Drug: Ketamine, Device: SmartSleep EEG recording headband |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketamine Assisted Psychotherapy3 Intravenous ketamine administrations (0.5mg/kg, not to exceed 40mg dose) immediately prior to a psychotherapy session over the span of 6 weeks | Drug | Adolescents with Severe PTSD |
| SmartSleep EEG recording headbandParticipants will complete 7 nights of at-home sleep recordings for exploratory analysis | Device | Adolescents with Severe PTSD |
Primary outcome
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.
2 secondary outcomes
Number of Participants Adhering to the Study Protocol
Time frame: up to 10 weeks
Number of Visits Completed Throughout the Study Duration
Time frame: up to 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Nicholas, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine and SmartSleep EEG recording headband in people with Posttraumatic Stress Disorder, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Adverse Events Attributable to Ketamine Administration (time frame: through the last study visit, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.