Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
16 participants
INTERVENTIONAL
2021-08-01
2024-03-31
Brief Summary
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Detailed Description
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(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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ketamine + eCBT
Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
Ketamine
Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
Online Trauma-Focused Cognitive Behavioural Therapy
Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
Control
Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.
No interventions assigned to this group
Interventions
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Ketamine
Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
Online Trauma-Focused Cognitive Behavioural Therapy
Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Queen's University
OTHER
Responsible Party
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Dr. Taras Reshetukha
Principle Investigator
Principal Investigators
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Taras Reshetukha, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Queen's University
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
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.
Philipp-Muller AE, Reshetukha T, Vazquez G, Milev R, Armstrong D, Jagayat J, Alavi N. Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 20;10(7):e30334. doi: 10.2196/30334.
Other Identifiers
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14521759
Identifier Type: -
Identifier Source: org_study_id
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