Grant: Project Grant
Unity Health Toronto
$608,175.00
Intravenous Ketamine versus Personalized Accelerated Brain Stimulation in Treatment-Resistant Depression: A Pilot Randomized Feasibility Trial of Rapid-Acting Treatments (IKARE-TRD)
FY 2023-24
Summary
Clinical depression affects more than 6 million Canadians. More than a third of them do not respond positively to antidepressant medications, meeting the criteria for treatment-resistant depression (TRD). Research shows that ketamine, a drug that blocks glutamatergic receptors, is effective at rapidly alleviating symptoms of depression and suicidality when but only in 30% of patients with TRD when administered intravenously. An alternative treatment, called personalized accelerated intermittent theta-burst stimulation (PaiTBS), is a potential solution: this treatment is non-invasive and likely easier for patients to follow and tolerate. PaiTBS is delivered over a shorter duration, and it potentially has higher remission rates (>50%) among patients with TRD compared to IVK (30%). Nevertheless, there is no head-to-head research study that would help identify which one of these interventions may be more feasible, tolerable, safer, and effective for people with TRD. Over 3 years, we will conduct a two-site pilot study (Edmonton/Toronto) with 80 patients between 18 to 65 years of age who have TRD. These patients will be randomly grouped to receive either a standard course of ketamine (3 weeks) or a novel course of PaiTBS (1 week). We will collect quantitative and qualitative data on factors that will help us determine which treatment may be viable for patients with TRD, such as how willing they are to enter the trial, be randomly assigned to one of the treatments, stick to the treatment regimen, and complete all scheduled assessments. We will also confirm how well-tolerated and safe these treatments are and will collect data that will help us design a more definitive future study recruiting a high number of patients. Ultimately, this line of research will lead to the development of new rapid-acting therapeutics for TRD in Canada, determine which patients benefit from which treatments, and improve outcomes for Canadians with psychiatric mood disorders.
Department
Program
Project Grant
Recipient
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
490031
Name
Bhat Venkat
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
Intravenous Ketamine versus Personalized Accelerated Brain Stimulation in Treatment-Resistant Depression: A Pilot Randomized Feasibility Trial of Rapid-Acting Treatments (IKARE-TRD)
Programtype2
Operating Grants
Orgnameinp2
Unity Health Toronto
Cihramount2
$608,175
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Brain Stimulation; Iv Ketamine; Pilot Trial; Randomized Controlled Trial; Treatment-Resistant Depression
Abstract
Clinical depression affects more than 6 million Canadians. More than a third of them do not respond positively to antidepressant medications, meeting the criteria for treatment-resistant depression (TRD). Research shows that ketamine, a drug that blocks glutamatergic receptors, is effective at rapidly alleviating symptoms of depression and suicidality when but only in 30% of patients with TRD when administered intravenously. An alternative treatment, called personalized accelerated intermittent theta-burst stimulation (PaiTBS), is a potential solution: this treatment is non-invasive and likely easier for patients to follow and tolerate. PaiTBS is delivered over a shorter duration, and it potentially has higher remission rates (>50%) among patients with TRD compared to IVK (30%). Nevertheless, there is no head-to-head research study that would help identify which one of these interventions may be more feasible, tolerable, safer, and effective for people with TRD. Over 3 years, we will conduct a two-site pilot study (Edmonton/Toronto) with 80 patients between 18 to 65 years of age who have TRD. These patients will be randomly grouped to receive either a standard course of ketamine (3 weeks) or a novel course of PaiTBS (1 week). We will collect quantitative and qualitative data on factors that will help us determine which treatment may be viable for patients with TRD, such as how willing they are to enter the trial, be randomly assigned to one of the treatments, stick to the treatment regimen, and complete all scheduled assessments. We will also confirm how well-tolerated and safe these treatments are and will collect data that will help us design a more definitive future study recruiting a high number of patients. Ultimately, this line of research will lead to the development of new rapid-acting therapeutics for TRD in Canada, determine which patients benefit from which treatments, and improve outcomes for Canadians with psychiatric mood disorders.
Competitiondate
202309
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Bhat, Venkat; Dunlop, Katharine A; Kcomt, Andrew; Ladha, Karim; Lou, Wen-Yi W; Swainson, Jennifer N; Zhang, Yanbo
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $608,175~ $0~