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Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

NCT06036511 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

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:

1. Does KAP improve symptoms of PTSD?
2. What changes in brain network connectivity are seen with KAP?

Conditions

Interventions

DRUG

Ketamine Hydrochloride

This is a single arm, open-label, prospective cohort clinical trial. No blinding is required for this trial. A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Sponsors & Collaborators

  • The Mind Research Network

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Snehal Bhatt, MD · UNM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036511 on ClinicalTrials.gov