Study Summary
This trial is testing whether a high-intensity ketamine treatment approach can help people with treatment-resistant depression, by reducing symptoms, side effects, and the need for ECT.
Eligible Conditions
- Major Depressive Disorder
- Ketamine
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: From date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks
Week 8
Patient satisfaction with treatment
Self- and clinician rated improvement
Suicidal ideation
Week 4
Number of treatments required to reach disease remission
Day 6
Rate of rescue ECT in the HIKER arm
Day 30
Cognitive Impairment
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Ketamine-ECT (EAST)
1 of 2
Ketamine (HIKER)
1 of 2
Active Control
Experimental Treatment
62 Total Participants · 2 Treatment Groups
Primary Treatment: Ketamine · No Placebo Group · Phase 4
Ketamine (HIKER)
Drug
Experimental Group · 1 Intervention: Ketamine · Intervention Types: DrugKetamine-ECT (EAST)ActiveComparator Group · 2 Interventions: Ketamine, ECT · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of disease remission or after 8 treatments and at 30 days following last treatment, assessed up to 8 weeks
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
239 Previous Clinical Trials
89,847 Total Patients Enrolled
Royal University Hospital FoundationOTHER
22 Previous Clinical Trials
6,809 Total Patients Enrolled
Jonathan Gamble, MDPrincipal InvestigatorUniversity of Saskatchewan
4 Previous Clinical Trials
464 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New York | 100.0% |
What site did they apply to?
| Royal University Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Zaw, Frank K.M.. 2006. “ECT and the Youth: Catatonia in Context”. International Review of Neurobiology. Elsevier. doi:10.1016/s0074-7742(05)72013-4.
- Gipson, Polly Y., Prachi Agarwala, Kiel J. Opperman, Adam Horwitz, and Cheryl A. King. 2015. “Columbia-suicide Severity Rating Scale”. Pediatric Emergency Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pec.0000000000000225.
- Kessler, Ronald C., Patricia Berglund, Olga Demler, Robert Jin, Kathleen R. Merikangas, and Ellen E. Walters. 2005. “Lifetime Prevalence and Age-of-onset Distributions of DSM-IV Disorders in the National Comorbidity Survey Replication”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.62.6.593.
- Berlim, Marcelo T, and Gustavo Turecki. 2007. “Definition, Assessment, and Staging of Treatment—resistant Refractory Major Depression: A Review of Current Concepts and Methods”. The Canadian Journal of Psychiatry. SAGE Publications. doi:10.1177/070674370705200108.
- Skolnick, P., R. Layer, P. Popik, G. Nowak, I. Paul, and R. Trullas. 1996. “Adaptation of N-methyl-d-aspartate (NMDA) Receptors Following Antidepressant Treatment: Implications for the Pharmacotherapy of Depression”. Pharmacopsychiatry. Georg Thieme Verlag KG. doi:10.1055/s-2007-979537.
- Bundy, Bogata D., Walter Hewer, Franz-Josef Andres, Peter Gass, and Alexander Sartorius. 2009. “Influence of Anesthetic Drugs and Concurrent Psychiatric Medication on Seizure Adequacy During Electroconvulsive Therapy”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.08m04971gre.
- Ghasemi, Mehdi, Mohammad H. Kazemi, Abolghasem Yoosefi, Abbas Ghasemi, Pedram Paragomi, Homayoun Amini, and Mohammad H. Afzali. 2014. “Rapid Antidepressant Effects of Repeated Doses of Ketamine Compared with Electroconvulsive Therapy in Hospitalized Patients with Major Depressive Disorder”. Psychiatry Research. Elsevier BV. doi:10.1016/j.psychres.2013.12.008.
- Metriyakool, Krisana. 1998. “Methohexital as Alternative to Propofol for Intravenous Anesthesia in Children Undergoing Daily Radiation Treatment”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000542-199803000-00035.
- Diamond, Peter R, Andrew D Farmery, Stephanie Atkinson, Jag Haldar, Nicola Williams, Phil J Cowen, John R Geddes, and Rupert McShane. 2014. “Ketamine Infusions for Treatment Resistant Depression: A Series of 28 Patients Treated Weekly or Twice Weekly in an ECT Clinic”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881114527361.
- Kirsch, Irving, Brett J Deacon, Tania B Huedo-Medina, Alan Scoboria, Thomas J Moore, and Blair T Johnson. 2008. “Initial Severity and Antidepressant Benefits: A Meta-analysis of Data Submitted to the Food and Drug Administration”. Edited by Phillipa Hay. Plos Medicine. Public Library of Science (PLoS). doi:10.1371/journal.pmed.0050045.
- Irwin, Scott A., Alana Iglewicz, Richard A. Nelesen, Jessica Y. Lo, Connie H. Carr, Sheilani D. Romero, and Linda S. Lloyd. 2013. “Daily Oral Ketamine for the Treatment of Depression and Anxiety in Patients Receiving Hospice Care: A 28-day Open-label Proof-of-concept Trial”. Journal of Palliative Medicine. Mary Ann Liebert Inc. doi:10.1089/jpm.2012.0617.
- Atkinson, Mark J., Ritesh Kumar, Joseph C. Cappelleri, and Steven L. Hass. 2005. “Hierarchical Construct Validity of the Treatment Satisfaction Questionnaire for Medication (TSQM Version II) Among Outpatient Pharmacy Consumers”. Value in Health. Elsevier BV. doi:10.1111/j.1524-4733.2005.00066.x.
- Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy [database on the Internet]. 2013 [cited 2017 Jan 1]
- Mathers C, Fat DM, Boerma JT. The global burden of disease: 2004 update: World Health Organization; 2008.
- Guy W. Clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Volume DHEW Publ No ADM. 1976;76(338):218-22
- Rush AJ, Blacker D. Handbook of psychiatric measures: American Psychiatric Pub; 2008
- Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. doi: 10.1177/070674370705200108.
- Fink M. Is Catatonia a Primary Indication for ECT? Convuls Ther. 1990;6(1):1-4. No abstract available.
- Datto CJ. Side effects of electroconvulsive therapy. Depress Anxiety. 2000;12(3):130-4. doi: 10.1002/1520-6394(2000)12:33.0.CO;2-C.
- Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health. 2005 Nov-Dec;8 Suppl 1:S9-S24. doi: 10.1111/j.1524-4733.2005.00066.x.
- Skolnick P, Layer RT, Popik P, Nowak G, Paul IA, Trullas R. Adaptation of N-methyl-D-aspartate (NMDA) receptors following antidepressant treatment: implications for the pharmacotherapy of depression. Pharmacopsychiatry. 1996 Jan;29(1):23-6. doi: 10.1055/s-2007-979537.
- Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added].
- Metriyakool K. Methohexital as alternative to propofol for intravenous anesthesia in children undergoing daily radiation treatment: a case report. Anesthesiology. 1998 Mar;88(3):821-2. doi: 10.1097/00000542-199803000-00035. No abstract available.
- Jonathan Gamble 2017. "ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03272698.
Frequently Asked Questions
Has the FDA granted official authorization to use Ketamine?
"We have rated Ketamine's safety as a 3, signifying that it has been approved by the FDA and is safe to use in Phase 4 clinical trials." - Anonymous Online Contributor
Unverified Answer
What is the number of people being recruited to participate in this medical experiment?
"Affirmative. Per the records uploaded on clinicaltrials.gov, this medical experiment is currently seeking volunteers. The trial was first listed on September 1st 2017 and most recently updated on October 31st 2022, with 62 patients being sought from a single hospital institution." - Anonymous Online Contributor
Unverified Answer
Is enrollment for this clinical research still open at present?
"Per the information currently available on clinicaltrials.gov, this trial is still actively looking for participants and has been since its initial posting on September 1st 2017 with a recent update occurring October 31st 2022." - Anonymous Online Contributor
Unverified Answer