NCT02577250

Ketamine Infusions for PTSD and Treatment-Resistant Depression

Efficacy and Safety of Repeated Intravenous Subanesthetic Ketamine Infusions Among Veterans With Treatment Resistant Depression Comorbid With Chronic Post-Traumatic Stress Disorder: A Proof-of-concept Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.

Detailed description

The proposed study is a pilot study designed to determine the efficacy and safety of serial ketamine infusions among veterans with treatment-resistant depression (TRD) as well as chronic post-traumatic stress disorder (PTSD). The investigators hypothesize that six infusions of ketamine will be effective in decreasing severity of depressive symptoms and maintaining response. Participants will be male/female veterans (18 to 75 years old) of any era or military background who suffer from TRD and chronic PTSD. Potential participants will be recruited from Mental Health clinics and screened for eligibility using a two stage process (phone/chart review, followed by interview). Participants will receive six ketamine infusions on a Monday-Wednesday-Friday schedule over 2 weeks. On the day of infusion, participants will be required to stay at the clinical site for 3 hours after the medication has been given. Follow-up visits will occur at different time points over the course of 2 months after the two week infusion period has been completed.

Conditions

• Depressive Disorder, Treatment-Resistant
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Ketamine	Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2015-10-16
• Last updated: 2019-05-14

Locations

1 site across 1 country: United States