Study Summary
This trial aims to study the effects of intranasal ketamine on patients with ultra-resistant depression, who have not responded to other treatments.
Eligible Conditions
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: 2 months
1 month
Change in quality of life measures as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Exploratory Measures
Impact of Ketamine on cortical inhibition as measured by short-interval cortical inhibition (SICI)
Safety and tolerability as assessed by changes in Blood Pressure (BP)
Safety and tolerability as assessed by changes in Heart Rate (BPM)
Safety and tolerability as assessed by changes in O2 Saturation
1 months
Impact of Ketamine on cortical excitation as measured by intracortical facilitation (ICF)
2 months
Change in symptom severity of Suicidal Ideation as measured by by the Scale of Suicide Ideation (SSI)
Change in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Improvement in symptom severity of Suicidal Ideation as measured by by the Scale of Suicide Ideation (SSI)
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Safety and Tolerability of IN Ketamine as assessed by monitoring of adverse events
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Intranasal Ketamine (IN)
1 of 1
Experimental Treatment
25 Total Participants · 1 Treatment Group
Primary Treatment: Intranasal Ketamine (IN) · No Placebo Group · N/A
Intranasal Ketamine (IN)
Drug
Experimental Group · 1 Intervention: Intranasal Ketamine (IN) · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
320 Previous Clinical Trials
76,030 Total Patients Enrolled
77 Trials studying Depression
15,956 Patients Enrolled for Depression
Yuliya Knyahnytska, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
30 Total Patients Enrolled
Eligibility Criteria
Age 21 - 65 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People who responded poorly to eight or more sessions of convulsive therapy, or who couldn't tolerate it, were excluded from the study.
in a health care setting
People who can consent and who are receiving outpatient care in a health care setting.
were included
People who were diagnosed with non-psychotic major depressive disorder (MDD) by the Mini-International Neuropsychiatric Interview (MINI) were included in the study.
Individuals who are suffering from a current episode of major depressive disorder and who meet criteria for ultra resistant major depressive disorder are a severe population in need of interventions.
You have a score of 14 or higher on the Hamilton Rating Scale for Depression-24 items.
Who else is applying?
What state do they live in?
| Ontario | 50.0% |
| Vermont | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Centre for Addiction and Mental Health | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I have bipolar II, Adhd, GAD, Gender Dysphoria, Borderline Personality Disorder, tried many medications"
What questions have other patients asked about this trial?
- "Is it free? and any compensation?"
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Most responsive sites:
- Centre for Addiction and Mental Health: < 48 hours
Average response time
- < 2 Days
References
- Knyahnytska, Yuliya, Reza Zomorrodi, Tyler Kaster, Daphne Voineskos, Alisson Trevizol, and Daniel Blumberger. 2022. “The Safety, Clinical, and Neurophysiological Effects of Intranasal Ketamine in Patients Who Do Not Respond to Electroconvulsive Therapy: Protocol for a Pilot, Open-label Clinical Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/30163.
- Knyahnytska, Yuliya, Reza Zomorrodi, Tyler Kaster, Daphne Voineskos, Alisson Trevizol, and Daniel Blumberger. 2022. “The Safety, Clinical, and Neurophysiological Effects of Intranasal Ketamine in Patients Who Do Not Respond to Electroconvulsive Therapy: Protocol for a Pilot, Open-label Clinical Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/30163.
- Knyahnytska, Yuliya, Reza Zomorrodi, Tyler Kaster, Daphne Voineskos, Alisson Trevizol, and Daniel Blumberger. 2022. “The Safety, Clinical, and Neurophysiological Effects of Intranasal Ketamine in Patients Who Do Not Respond to Electroconvulsive Therapy: Protocol for a Pilot, Open-label Clinical Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/30163.
- 2021. "Intranasal Ketamine in Ultra-REsistant Depression (SURE-ECT Non Responders)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05137938.
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