Status:
UNKNOWN
Combined Ketamine and eCBT Intervention for PTSD
Lead Sponsor:
Queen's University
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
Detailed Description
OBJECTIVES (i) To introduce a previously untreated patient population with PTSD to new therapeutic options. (ii) To provide new insights into the functional role of Glutamate in affective disorders ...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
- Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
- Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
- Participants must speak and read English, and will have consistent and reliable access to the internet.
- Patients with suicidal ideation will be included.
- Patients with a history of substance abuse will be included (except for opioid use disorder).
Exclusion
- Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04771767
Start Date
August 1 2021
End Date
March 31 2024
Last Update
August 11 2022
Active Locations (1)
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1
Queen's University
Kingston, Ontario, Canada, K7L 3N6