- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560660
Ketamine-enhanced Prolonged Exposure Therapy in PTSD
May 15, 2023 updated by: VA Office of Research and Development
Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paulo R Shiroma, MD
- Phone Number: 612467 (612) 725-2000
- Email: Paulo.Shiroma@va.gov
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417-2309
- Recruiting
- Minneapolis VA Health Care System, Minneapolis, MN
-
Principal Investigator:
- Paulo R Shiroma, MD
-
Contact:
- Gloria Wang, BS
- Phone Number: 612-467-2974
- Email: gloria.wang2@va.gov
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine and prolonged exposure (PE)
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
FDA approved anesthetic medication with rapid acting antidepressant effects.
|
Placebo Comparator: Midazolam and prolonged exposure (PE)
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|
FDA approved sedative medication with dissociative effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paulo R Shiroma, MD, Minneapolis VA Health Care System, Minneapolis, MN
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)
March 9, 2021
Primary Completion (Anticipated)
June 18, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
September 17, 2020
First Submitted That Met QC Criteria
September 17, 2020
First Posted (Actual)
September 23, 2020
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Ketamine
- Midazolam
Other Study ID Numbers
- MHBP-006-19F
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.
No
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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