Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02397889|
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : October 8, 2018
|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)|
|Estimated Enrollment :||40 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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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 post-infusion ]
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours 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
|Contact: Abigail Collinsemail@example.com|
|United States, New York|
|Mood and Anxiety Disorders Program (MAP)||Recruiting|
|New York, New York, United States, 10029|
|Contact: Abigail Collins 212-241-7910 firstname.lastname@example.org|
|Principal Investigator: Adriana Feder, MD|
|Principal Investigator:||Adriana Feder, MD||Icahn School of Medicine at Mount Sinai|