The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Ketamine-enhanced Prolonged Exposure Therapy in PTSD
Ketamine (DRUG)FDA approved anesthetic medication with rapid acting antidepressant effects.
Midazolam (DRUG)FDA approved sedative medication with dissociative effects.
Condition or Disease
|Study results:||No Results Available|
|Age:||18 Years to 75 Years|
|Funded by:||U.S. Fed|
The investigators will use a sequentially numbered, opaque, sealed envelopes, pharmacy-controlled allocations, and coded identical containers for adequate concealment allocation. Administration of study drugs and infusion monitoring will be conducted by research nurse keeping blinding from investigators and independent outcome assessors.QUADRUPLE:
Clinical Trial Dates
|Start date:||Mar 09, 2021||ACTUAL|
|Primary Completion:||Jun 18, 2024||ESTIMATED|
|Completion Date:||Dec 31, 2024||ESTIMATED|
|Study First Posted:||Sep 23, 2020||ACTUAL|
|Last Updated:||May 15, 2023|
Sponsors / Collaborators
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
|Age Groups:||Adult / Older Adult|
* male or female Veterans between the ages of 18 and 75 years
* diagnosis of PTSD
* ability to provide written informed consent
* females who are currently pregnant or breastfeeding
* current high risk for suicide
* history of moderate/severe head injury
* history of psychosis
* current episode of mania/hypomania
* severe substance and/or alcohol use disorder in the last 6 months
This clinical trial is recruiting
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