drugset / Trial / NCT06036511
Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn about the effects of Ketamine Assisted Psychotherapy \[KAP\] on individuals with Post Traumatic Stress Disorder \[PTSD\]. The main questions it aims to answer are: 1. Does KAP improve symptoms of PTSD? 2. What changes in brain network connectivity are seen with KAP?
Timeline
- Start
- 2023-12-31
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Publications
- Background Drozdz SJ, Goel A, McGarr MW, Katz J, Ritvo P, Mattina GF, Bhat V, Diep C, Ladha KS. Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature. J Pain Res. 2022 Jun 15;15:1691-1706. doi: 10.2147/JPR.S360733. eCollection 2022.
- Background Joneborg I, Lee Y, Di Vincenzo JD, Ceban F, Meshkat S, Lui LMW, Fancy F, Rosenblat JD, McIntyre RS. Active mechanisms of ketamine-assisted psychotherapy: A systematic review. J Affect Disord. 2022 Oct 15;315:105-112. doi: 10.1016/j.jad.2022.07.030. Epub 2022 Jul 26.
- Background Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
- Background Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5.
- Background Ionescu DF, Felicione JM, Gosai A, Cusin C, Shin P, Shapero BG, Deckersbach T. Ketamine-Associated Brain Changes: A Review of the Neuroimaging Literature. Harv Rev Psychiatry. 2018 Nov/Dec;26(6):320-339. doi: 10.1097/HRP.0000000000000179.
- Background Norbury A, Rutter SB, Collins AB, Costi S, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Glasgow AM, Brallier J, Shin LM, Charney DS, Murrough JW, Feder A. Neuroimaging correlates and predictors of response to repeated-dose intravenous ketamine in PTSD: preliminary evidence. Neuropsychopharmacology. 2021 Dec;46(13):2266-2277. doi: 10.1038/s41386-021-01104-4. Epub 2021 Jul 31.
- Background Krystal JH, Abdallah CG, Averill LA, Kelmendi B, Harpaz-Rotem I, Sanacora G, Southwick SM, Duman RS. Synaptic Loss and the Pathophysiology of PTSD: Implications for Ketamine as a Prototype Novel Therapeutic. Curr Psychiatry Rep. 2017 Aug 26;19(10):74. doi: 10.1007/s11920-017-0829-z.
- Background Patel R, Spreng RN, Shin LM, Girard TA. Neurocircuitry models of posttraumatic stress disorder and beyond: a meta-analysis of functional neuroimaging studies. Neurosci Biobehav Rev. 2012 Oct;36(9):2130-42. doi: 10.1016/j.neubiorev.2012.06.003. Epub 2012 Jul 2.
- Background Sheynin J, Liberzon I. Circuit dysregulation and circuit-based treatments in posttraumatic stress disorder. Neurosci Lett. 2017 May 10;649:133-138. doi: 10.1016/j.neulet.2016.11.014. Epub 2016 Nov 12.
- Background Stopyra MA, Simon JJ, Rheude C, Nikendei C. Pathophysiological aspects of complex PTSD - a neurobiological account in comparison to classic posttraumatic stress disorder and borderline personality disorder. Rev Neurosci. 2022 Aug 8;34(1):103-128. doi: 10.1515/revneuro-2022-0014. Print 2023 Jan 27.
- Background Fonzo GA, Goodkind MS, Oathes DJ, Zaiko YV, Harvey M, Peng KK, Weiss ME, Thompson AL, Zack SE, Lindley SE, Arnow BA, Jo B, Rothbaum BO, Etkin A. Amygdala and Insula Connectivity Changes Following Psychotherapy for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry. 2021 May 1;89(9):857-867. doi: 10.1016/j.biopsych.2020.11.021. Epub 2020 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | — | Intramuscular |