Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05137938
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-11-02
Brief Title:
Intranasal Ketamine in Ultra-REsistant Depression SURE-ECT Non Responders
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Safety and Clinical Effects of Intranasal Ketamine in Ultra-REsistant Depression SURE-ECT Non Responders Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURE-ECT
Brief Summary:
Despite the known efficacy of pharmacotherapy ie antidepressants and psychotherapeutic interventions in treating depressive disorders research evidence suggests that 20 to 40 of patients with major depressive disorder MDD do not respond adequately to such treatments These patients are diagnosed with Treatment-Resistant Depression TRD and are sometimes treated with convulsive therapy However about 10-30 of TRD patients do not respond to convulsive therapy and are thus diagnosed with Ultra-Resistant Depression URD Using an open label pilot study involving subjects this trial aims to assess the safety tolerability and clinical effects of intranasal ketamine IN treatment in patients who do not respond to convulsive therapy Intranasal ketamine IN treatment approach has shown promising therapeutic outcomes for patients with TRD but has not yet been studied on patients with URD
Detailed Description:
Ketamine is a fast-acting anesthetic that can have stimulant effects when taken at low doses It acts as a non-competitive high-affinity N-methyl-d-aspartate NMDA receptor antagonist that stimulates synaptic glutamate release and blocks extra-synaptic NMDA receptors This mechanism of action mediates excitatory synaptic transmission through the central nervous system and therefore results in robust antidepressant effects Administering intravenous IV ketamine to patients with TRD has shown to produce rapid antidepressant effects Nevertheless delivering IV ketamine to patients can be challenging since it requires specialized expertise and equipment A promising alternative that preserves IV ketamines rapid onset of therapeutic action while minimizing inconvenience and discomfort is intranasal drug delivery IN This current proof-of-concept clinical trial is an open label pilot study on patients with treatment-resistant unipolar depression who did not respond to or did not tolerate an acute course of convulsive therapy Using a combination of Transcranial Magnetic Stimulation TMS neurophysiological tools with electromyography EMG and electroencephalography EEG this trial also aims to explore biomarkers of ketamines antidepressant effect by examining ketamines action on NMDA neurotransmission Investigating the impact of ketamine on cortical excitation and inhibition could provide insight into the role of NMDA receptors in cortical physiology and therefore determine potential predictors of clinical response for depression
Objective 1 To test the safety and tolerability of IN ketamine in patients with URD who did not respond totolerate an acute course of convulsive therapy
Hypothesis 1 IN ketamine will be safe and well tolerated in patients with URD
Objective 2 To test the clinical effects of IN ketamine patients with URD who did not respond totolerate an acute course of convulsive therapy
Hypothesis 2 IN ketamine will result in improvement in depressive symptoms suicidal ideation and quality of life measures compared to scores from baseline
Objective 3 To investigate the impact of ketamine on cortical excitation via intracortical facilitation ICF and cortical inhibition via short-interval cortical inhibition SICI paradigms
Hypothesis 3 IN ketamine will result in neurophysiological changes as measured by TMS-EMG and EEG
Objective 1 To test the safety and tolerability of IN ketamine in patients with URD who did not respond totolerate an acute course of convulsive therapy
Hypothesis 1 IN ketamine will be safe and well tolerated in patients with URD
Objective 2 To test the clinical effects of IN ketamine patients with URD who did not respond totolerate an acute course of convulsive therapy
Hypothesis 2 IN ketamine will result in improvement in depressive symptoms suicidal ideation and quality of life measures compared to scores from baseline
Objective 3 To investigate the impact of ketamine on cortical excitation via intracortical facilitation ICF and cortical inhibition via short-interval cortical inhibition SICI paradigms
Hypothesis 3 IN ketamine will result in neurophysiological changes as measured by TMS-EMG and EEG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None