Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT02397889|
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder (PTSD)||Drug: Ketamine Drug: Midazolam||Phase 2 Phase 3|
Ketamine is an approved medication in several countries for the induction of general anesthesia and for use as adjunct to other anesthetics. Intravenous ketamine is being developed and tested for the treatment of posttraumatic stress disorder (PTSD).
All subjects will be administered the study medication by the study anesthesiologists and under the direct supervision of the investigator or designee. On all dosing days, all subjects must remain at the clinical site until at least 4 hours post-dose (or longer if required for study procedures) and will be accompanied by a responsible adult when discharged from the clinical site. The end of study will occur when the last subject in the trial completes his/her last study assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||January 27, 2020|
|Actual Study Completion Date :||January 27, 2020|
Experimental: Experimental ketamine group
This arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).
Other Name: Generic only
Active Comparator: Active control midazolam group
This arm will receive 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
Other Name: Generic only
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]
- The Impact of Event Scale - Revised (IES-R) [ Time Frame: 24 hours after the first drug infusion ]
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours after the first drug infusion ]
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks after the first drug infusion ]
- Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: up to 21 weeks ]
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): NCT02397889
|United States, New York|
|Depression and Anxiety Center (DAC)|
|New York, New York, United States, 10029|
|Principal Investigator:||Adriana Feder, MD||Icahn School of Medicine at Mount Sinai|