Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD (CONCHKAP)

March 8, 2024 updated by: Snehal Bhatt, MD, University of New Mexico

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?

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first ketamine administration session:

Between the ages of 18 to 65 years old.

Meet DSM-5 criteria for Port-Traumatic Stress Disorder [PTSD] based on clinical interview.

Able to provide informed consent.

Are proficient in reading and speaking English.

Agree to refrain from using stimulants during the day of the medication session.

Agree to refrain from alcohol and cannabis for 24 hours before and the day of medication session.

Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.

Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration.

If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session.

Able to identify one or two caregiver support persons who can drive participant home, stay with them overnight, be reached by the team, and provide collateral information as needed.

Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned.

Exclusion Criteria:

  • Participants will be excluded from the study if any of the following criteria apply:

They are considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.

Have had a psychiatric or medical hospitalization, or an Emergency Department visit, within four weeks of the study entry.

Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.

Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.

Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.

Subjects who report use of ketamine >20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission.

Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the study.

Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.

A history of allergic or other adverse reaction to ketamine (or its excipients).

Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).

QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded.

High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).

Documented evidence of significant renal or hepatic dysfunction at screening. Significantly impaired liver function is defined as 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); 2) ALT or AST > 3 × ULN with concomitant total bilirubin > 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.

Blood pressure will be monitored at all subsequent visits, and participants will receive study medication only if blood pressure is less than or equal to 140 systolic, 90 diastolic at safety screening on the day of the drug administration sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine Assisted Psychotherapy [KAP]
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.
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.

Other Names:
  • KAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome: PTSD severity
Time Frame: 14-21 days
as defined by change in score on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) following KAP treatments (Assessment Visit 3) compared to baseline (Assessment Visit 1).
14-21 days
Imaging Outcome: Changes in functional connectivity
Time Frame: 28-35 days
change in the functional connectivity between vmPFC and amygdala from Baseline to Assessment Visit 4 as measured by fMRI.
28-35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression severity
Time Frame: 14-21 days
Improvement in depression, as indicated by reduced Montgomery-Asberg Depression Rating Scale (MADRS), following KAP treatments (Assessment Visit 3) compared to baseline (Assessment Visit 1).
14-21 days
Correlation of clinical and imaging outcomes
Time Frame: 28-35 days
Change in connectivity between the vmPFC and amygdala from Assessment Visit 1 to Assessment Visit 4 with degree of PTSD symptom change.
28-35 days
Persisting PTSD effect
Time Frame: 28-35 days
The changes in score on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
28-35 days
Persisting MDD effect
Time Frame: 28-35 days
Concurrent MDD (MADRS) will persist at last evaluation two weeks after completion of active treatment.
28-35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

The Mind Research Network

Investigators

  • Principal Investigator: Snehal Bhatt, MD, UNM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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