Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480500
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2022-03-16
Brief Title:
i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression A Randomized Midazolam-Controlled Clinical Trial
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Integrated Internet-Based Cognitive Behavioural Therapy i-CBT and Intravenous Ketamine for Suicidality in Treatment-Resistant Depression A Randomized Midazolam-Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Ket-CBT
Brief Summary:
Approximately four thousand Canadians die by suicide every year and suicide is the second leading cause of death in youth and young adults 15-34 years Most people with depression experience thoughts of suicide and many will also plan andor attempt suicide at some time in their life There is an urgent need for new scalable treatments that can effectively reduce suicidality in people with depression
Cognitive behavioural therapy CBT reduces suicidal thoughts and behaviours and can be delivered through the internet i-CBT making it more accessible and scalable However i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours suicidality such as within 24 hours IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide but not suicidal behaviours
Therefore combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment
The investigators propose a 13-week multi-site study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts andor behaviours but have not responded to previous treatment All 110 participants will receive a weekly session of i-CBT for 13 weeks but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments control treatment over the first initial 30 days The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint ieday 30 and after 3 months ie Day 91 of the starting treatment
Cognitive behavioural therapy CBT reduces suicidal thoughts and behaviours and can be delivered through the internet i-CBT making it more accessible and scalable However i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours suicidality such as within 24 hours IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide but not suicidal behaviours
Therefore combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment
The investigators propose a 13-week multi-site study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts andor behaviours but have not responded to previous treatment All 110 participants will receive a weekly session of i-CBT for 13 weeks but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments control treatment over the first initial 30 days The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint ieday 30 and after 3 months ie Day 91 of the starting treatment
Detailed Description:
None
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