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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
3 Intravenous ketamine administrations (0.5mg/kg, not to exceed 40mg dose) immediately prior to a psychotherapy session over the span of 6 weeks
Participants will complete 7 nights of at-home sleep recordings for exploratory analysis
University of Wisconsin
Madison, Wisconsin, United States
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.
Time frame: through the last study visit, up to 10 weeks
Number of Participants Adhering to the Study Protocol
Study protocol adherence for preparation, dosing, and follow-up visits.
Time frame: 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.
Time frame: up to 10 weeks
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