Ketamine for PTSD and Depression

Palo Alto (17 mi)

Overseen byCristina S Albott, MD, MA

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Minnesota

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk than individuals with only one of these disorders. Ketamine given as repeated infusions has been shown to be effective in rapidly reducing PTSD and MDD symptoms in treatment resistant PTSD+MDD individuals. However, knowledge about the mechanisms underlying comorbid PTSD and MDD remain limited. The purpose of this study is to use repeated ketamine infusions as a probe to validate a model of PTSD+MDD that focuses on neuroanatomy and executive functioning.

Eligibility Criteria

This trial is for veterans aged 18-75 with PTSD and/or MDD who can read at a sixth-grade level and consent to participate. It's not for those with severe cognitive issues, psychosis-related disorders, recent substance abuse, or unstable medical conditions. Pregnant women or those unable to undergo MRI are also excluded.

Inclusion Criteria

I do not have moderate to severe depression without psychosis.

I am not taking any medications for mental health issues.

I have been diagnosed with moderate to severe depression without psychosis.

I am between 18 and 75 years old.

Treatment Details

The study tests repeated ketamine infusions against saline (placebo) in reducing symptoms of PTSD and MDD in veterans. The goal is to understand how these conditions affect brain function and structure.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intravenous ketamine infusionsExperimental Treatment1 Intervention

Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 3 weeks.

Group II: Intravenous saline infusionsPlacebo Group1 Intervention

Six infusions of normal saline solution over 3 weeks.

Ketamine is already approved in United States, European Union, United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Ketalar for: