Ketamine-assisted therapy for teens with PTSD

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

This study is testing whether giving ketamine before therapy can help teens with severe PTSD feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 15 Years to 17 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT06378528 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility, tolerability, and preliminary efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents diagnosed with severe posttraumatic stress disorder (PTSD). Participants aged 15-17 will receive three intravenous ketamine administrations before psychotherapy sessions over six weeks, along with preparatory and integration sessions. The study aims to assess safety and adverse events while exploring the potential reduction in PTSD symptoms following treatment.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 15-17 who meet the DSM-5 criteria for current PTSD.

Not a fit: Patients with conditions that may contraindicate the use of ketamine or those not meeting the PTSD criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce PTSD symptoms in adolescents, improving their overall mental health and quality of life.

How similar studies have performed: Other studies have shown promising results with ketamine-assisted therapies for PTSD, indicating potential for success in this approach.

Eligibility criteria

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 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.

Where this trial is running

Madison, Wisconsin

• University of Wisconsin — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Ryan J Herringa, MD, PhD — University of Wisconsin, Madison
• Study coordinator: Sara Heyn, JD, PhD

Conditions Posttraumatic Stress Disorder