Study Summary
This trial is testing whether a combination of Ketamine and online Cognitive Behavioural Therapy is effective for treating PTSD.
- Post Traumatic Stress Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Control
1 of 3
Waitlist-Control
1 of 3
Ketamine + eCBT
1 of 3
Active Control
Experimental Treatment
16 Total Participants · 3 Treatment Groups
Primary Treatment: Ketamine · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Arizona | 33.3% |
| Ontario | 33.3% |
| Alberta | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 66.7% |
| Met criteria | 33.3% |
What site did they apply to?
| Queen's University | 100.0% |
Why did patients apply to this trial?
- "I have severe treatment resistant depression, and nothing has worked in years. Maybe this would work? I'm willing to try a lot of things at this point and I'm based in kingston for the time being so kind of perfect."
How many prior treatments have patients received?
| 3+ | 100.0% |
- Feder, Adriana, Michael K. Parides, James W. Murrough, Andrew M. Perez, Julia E. Morgan, Shireen Saxena, Katherine Kirkwood, et al.. 2014. “Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2014.62.
- Philipp-Muller, Aaron Emile, Taras Reshetukha, Gustavo Vazquez, Roumen Milev, Dawn Armstrong, Jasleen Jagayat, and Nazanin Alavi. 2021. “Combining Ketamine and Internet-based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/30334.
- 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.
- Alavi, Nazanin, Matthew Stefanoff, Alyssa Hirji, and Sarosh Khalid-Khan. 2018. “Cognitive Behavioural Therapy Through Powerpoint: Efficacy in an Adolescent Clinical Population with Depression and Anxiety”. International Journal of Pediatrics. Hindawi Limited. doi:10.1155/2018/1396216.
- Girgenti, Matthew J., Sriparna Ghosal, Dora LoPresto, Jane R. Taylor, and Ronald S. Duman. 2017. “Ketamine Accelerates Fear Extinction via Mtorc1 Signaling”. Neurobiology of Disease. Elsevier BV. doi:10.1016/j.nbd.2016.12.026.
- Pradhan, Basant, Ludmil Mitrev, Ruin Moaddell, and Irving W. Wainer. 2018. “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”. Biochimica Et Biophysica Acta (BBA) - Proteins and Proteomics. Elsevier BV. doi:10.1016/j.bbapap.2018.03.006.
- 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.
- Dr. Taras Reshetukha 2021. "Combined Ketamine and eCBT Intervention for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04771767.
Frequently Asked Questions
Does this medical study permit individuals below the age of 75 to participate?
"This trial requires that participants be between 18 and 65 years of age. In addition, there are 58 clinical trials catering to minors and 410 for seniors." - Anonymous Online Contributor
Does my background and health history meet the criteria for participating in this medical experiment?
"The trial is recruiting 16 individuals aged 18 to 65 suffering from stress-related disorders and trauma. To qualify, their symptoms must have been assessed using the CAPS-5 test by a psychiatrist on the team with score of at least 50, they should have received two unsuccessful prior treatments, those with hypertension or cardiovascular disease should be under stable treatment, patients presenting suicidal ideation may join as well as those battling substance abuse (except for opioid use disorder)." - Anonymous Online Contributor
How many participants have signed up for this clinical experiment?
"Affirmative. Per the data yielded from clinicaltrials.gov, this trial is actively seeking participants and was first posted on August 1st 2021. The current goal is to recruit a total of 16 patients across one site before the study's last update on 8th August 2022." - Anonymous Online Contributor
Are there potential health risks with Ketamine usage?
"There is some evidence of Ketamine's safety, so it was adjudged a 2 on the scale. However, no data exists to support its efficacy at this time." - Anonymous Online Contributor
Does this medical trial have any vacancies for participants?
"Clinicaltrials.gov attests that this clinical trial is open for patient recruitment, with the initial post dating back to August 1st 2021 and a recent edit made on the 8th of August 2022." - Anonymous Online Contributor