Combined Ketamine and eCBT Intervention for PTSD

This open-label randomized controlled trial (n=16) investigates the efficacy of a combined treatment approach for PTSD, using ketamine infusions and online Cognitive Behavioural Therapy (CBT).

Led by Queen’s University, the study aims to introduce new therapeutic options for refractory PTSD patients and provide insights into the role of Glutamate in affective disorders and learning. The trial involves 16 participants with refractory PTSD who will receive either a combination of Ketamine and eCBT over 12 weeks or serve as controls. Assessments will be conducted at various intervals to gauge the efficacy of the treatment.

Participants must have a diagnosis of PTSD, have received ineffective prior treatments, and have consistent internet access. Individuals with specific exclusion criteria, such as acute psychosis or active homicidal ideation, will not be eligible.

The primary outcome measure will be the change in scores on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), assessed at 0, 4, 8, and 12 weeks from the start of treatment. Secondary outcome measures include changes in scores on various scales related to depression, suicide severity, disability, and global functioning.

The trial started on August 1, 2021, and is expected to conclude on March 31, 2024, with an estimated enrollment of 16 participants. For further information, interested parties can contact Aaron E Philipp-Muller, B.Sc., at Queen’s University.

Topic PTSD
Compound Ketamine
Country Canada
Visit trial
Status Recruiting
Results Published No
Start date 01 August 2021
End date 31 March 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 16
Sex All
Age 18- 65
Therapy Yes

Trial Details

An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.

NCT Number NCT04771767

Sponsors & Collaborators

Queen's University
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Data attribution

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