Using ketamine with therapy to treat PTSD in veterans
Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD
This study is testing if giving veterans with PTSD ketamine along with therapy can help reduce their symptoms better than just therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04560660 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of repeated doses of ketamine when combined with prolonged exposure therapy for veterans suffering from PTSD. Participants will be randomly assigned to receive either ketamine or a placebo alongside the therapy. The treatment involves intravenous infusion of the study drug once a week for three weeks, allowing researchers to assess the impact on PTSD symptoms. The study focuses on veterans to address the unique challenges they face regarding mental health.
Who should consider this trial
Good fit: Ideal candidates are male or female veterans aged 18 to 75 with a diagnosis of PTSD.
Not a fit: Patients who are currently pregnant, at high risk for suicide, or have a history of severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce PTSD symptoms in veterans, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results using ketamine for PTSD, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Paulo R Shiroma, MD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Paulo R Shiroma, MD
- Email: Paulo.Shiroma@va.gov
- Phone: (612) 725-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.