Combined Ketamine and eCBT Intervention for PTSD

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771767
• Other study ID #: 14521759
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2022
• Source: Queen's University
• Contact: Aaron E Philipp-Muller, B.Sc.
• Phone: 416-939-3164
• Email: 19aepm1[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

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.

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Alavi N, Stefanoff M, Hirji A, Khalid-Khan S. Cognitive Behavioural Therapy through PowerPoint: Efficacy in an Adolescent Clinical Population with Depression and Anxiety. Int J Pediatr. 2018 Nov 8;2018:1396216. doi: 10.1155/2018/1396216. eCollection 2018. — View Citation

Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;(12):CD003388. doi: 10.1002/14651858.CD003388.pub4. Review. — View Citation

Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62. — View Citation

Girgenti MJ, Ghosal S, LoPresto D, Taylor JR, Duman RS. Ketamine accelerates fear extinction via mTORC1 signaling. Neurobiol Dis. 2017 Apr;100:1-8. doi: 10.1016/j.nbd.2016.12.026. Epub 2016 Dec 30. — View Citation

Pradhan B, Mitrev L, Moaddell R, Wainer IW. d-Serine is a potential biomarker for clinical response in treatment of post-traumatic stress disorder using (R,S)-ketamine infusion and TIMBER psychotherapy: A pilot study. Biochim Biophys Acta Proteins Proteom. 2018 Jul;1866(7):831-839. doi: 10.1016/j.bbapap.2018.03.006. Epub 2018 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Scores on the Clinician Administered PTSD Scale for DSM-5	Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.	0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Secondary	Change in Scores on the Montgomery Asberg Depression Rating Scale	Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.	0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Secondary	Change in Scores on the Columbia Suicide Severity Rating Scale	Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.	0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Secondary	Change in Scores on the Sheehan Disabilities Scale	A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.	0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Secondary	Change in Scores on the Global Assessment of Functioning	Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.	0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start