Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

This single-arm, open-label trial (n=14) will investigate the effects of Ketamine Assisted Psychotherapy (KAP) on individuals with Post Traumatic Stress Disorder (PTSD).

Conducted by the University of New Mexico, the study aims to answer whether KAP improves PTSD symptoms and what changes in brain network connectivity are observed. Adult patients meeting DSM-5 criteria for PTSD will undergo rsfMRI and behavioural assessment before receiving intramuscular ketamine treatment.

Each participant will undergo two complete KAP sessions, including preparation, treatment, and integration, followed by rsfMRI scans. Changes in PTSD symptoms will be correlated with changes in connectivity observed in the brain scans.

The primary outcome measure is the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score, while secondary measures include changes in depression severity and persisting effects of PTSD and major depressive disorder (MDD). Recruitment is estimated to start in December 2023, with completion expected by August 2024.

Status Not yet recruiting
Results Published No
Start date 31 December 2023
End date 31 August 2024
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 14
Sex All
Age 18- 65
Therapy Yes

Trial Details

The goal of this clinical trial is to learn about the effects of Ketamine Assisted Psychotherapy [KAP] on individuals with Post Traumatic Stress Disorder [PTSD]. The main questions it aims to answer are: - Does KAP improve symptoms of PTSD? - What changes in brain network connectivity are seen with KAP?

NCT Number NCT06036511

Sponsors & Collaborators

University of New Mexico
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