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.
Compound Ketamine
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
05 January 2015
End date
07 January 2016
Chance of happening
100%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
20
Sex
All
Age
18- 75
Therapy
No
Trial Details
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.NCT Number NCT02577250
Sponsors & Collaborators
Minneapolis Veterans Affairs Medical CenterThis company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant DepressionThis is the first open-label study (2018) to assess the effects of repeated ketamine infusions in the treatment of comorbid PTSD and treatment-resistant depression (TRD) (n=15). Participants received six IV ketamine infusions (0.5 mg/kg) on a Monday-Wednesday-Friday schedule over a 12-day period. Ketamine significantly reduced measures of symptoms change for both disorders (MADRS & PTSD Checklist for DSM-V) and the remission rate for PTSD and TRD were 80% and 93.3%, respectively.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Clinician-Administered PTSD Scale for DSM-5
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is often considered the gold standard in PTSD assessment. The 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Centre for PTSD. CAPS can be used to make a current diagnosis, lifetime diagnosis or assess PTSD symptoms over the past week in accordance with DSM-5 criteria.