Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Post Traumatic Stress Disorder
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants diagnosed with PTSD will be randomly assigned either to the experimental treatment or a waitlist control. Data will be collected from participants in both groups at the same 3 time-points.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 as well as in learning and memory. (iii) To explore the utility of pharmacologically-enhanced psychoth...

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 as well as in learning and memory. (iii) To explore the utility of pharmacologically-enhanced psychotherapy. OUTLINE The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 20 participants with refractory PTSD will be randomly assigned either to an experimental group receiving a combination of Ketamine and eCBT over 14 weeks, or they will be assigned to a 14-week waitlist-control group (at the end of which they would receive the experimental treatment). Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at the 7-week halfway point, and at the end of the 14 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the waitlist-control.

Tracking Information

NCT #
NCT04771767
Collaborators
Not Provided
Investigators
Principal Investigator: Taras Reshetukha, MD Queen's University