PTSDPhase 2NCT04560660
Ketamine-enhanced Prolonged Exposure Therapy in PTSD
A Phase 2 study testing Ketamine and Midazolam in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PTSD
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 7 Oct 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female Veterans between the ages of 18 and 75 years
- diagnosis of PTSD
- ability to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Official title: 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.
Read the 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.
- Conditions
- PTSD
- Keywords
- Post-traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
FDA approved anesthetic medication with rapid acting antidepressant effects.
MidazolamDrug
FDA approved sedative medication with dissociative effects.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine and prolonged exposure (PE) | Experimental | 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. Receives: Drug: Ketamine |
| Midazolam and prolonged exposure (PE) | Placebo comparator | 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. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Week 4
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.
Measured: Week 10
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.
Measured: Week 14
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.
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start9 Mar 2021
- Primary completion1 Jul 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to one of two parallel treatment conditions: 1) adjunctive ketamine infusions to prolonged exposure therapy or 2) adjunctive midazolam (active placebo) infusions to prolonged exposure therapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paulo R Shiroma, MD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560660
- Sponsor's protocol ID
- MHBP-006-19F
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2020
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No