Ketamine-enhanced Prolonged Exposure Therapy in PTSD

PTSD Clinical Trial

Official title:

Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560660
• Other study ID #: MHBP-006-19F
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Paulo R Shiroma, MD
• Phone: (612) 725-2000
• Email: Paulo.Shiroma[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.

Description:

In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• male or female Veterans between the ages of 18 and 75 years

• diagnosis of PTSD

• ability to provide written informed consent

Exclusion Criteria:

• females who are currently pregnant or breastfeeding

• current high risk for suicide

• history of moderate/severe head injury

• history of psychosis

• current episode of mania/hypomania

• severe substance and/or alcohol use disorder in the last 6 months

Related Conditions & MeSH terms

• PTSD

Intervention

Drug:
• Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
• Midazolam
FDA approved sedative medication with dissociative effects.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.	CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)