NCT04771767

Combined Ketamine and eCBT Intervention for PTSD

Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 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 control.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
BEHAVIORAL	Online Trauma-Focused Cognitive Behavioural Therapy	Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2021-02-25
• Last updated: 2022-08-11

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study