Ketamine Infusions for PTSD and Treatment-Resistant Depression
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|ClinicalTrials.gov Identifier: NCT02577250|
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Treatment-Resistant Stress Disorders, Post-Traumatic||Drug: Ketamine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours post-infusion ]
- Clinical-Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: up to 2 months ]
- PTSD Checklist [ Time Frame: 24 hours post-infusion ]
- Clinical-Administered PTSD Scale (CAPS) [ Time Frame: up to 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577250
|United States, Minnesota|
|Minneapolis Va Health Care System, Minneapolis MN|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Paulo Shiroma, MD||Minneapolis Veterans Affairs Medical Center|
|Principal Investigator:||Cristina S Albott, MD,MA||Minneapolis Veterans Affairs Medical Center|