Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT03537794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-20
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterizing Dopamine Receptor Binding in Treatment Resistant Depression
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
Characterizing Dopamine D2 and D3 Receptor Binding in Treatment Resistant Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
It is estimated that 30% of individuals with Major Depressive Disorder (MDD) fail to respond to conventional antidepressant medication which accounts for over 1 million Canadians in their lifetime. Treatment resistant depression (TRD) patients also have greater psychiatric and medical comorbidity, poorer quality of life and increased suicidal ideation. Yet, there are few treatment strategies available to target TRD and there is a significant lack of evidence about how TRD differs from treatment-responsive depression. This proposal represents the first study to elucidate the neurobiology of TRD with a focus on dopamine receptor function throughout the brain, in order to inform treatment development and clinical characterization of TRD.The ultimate goal of this unique study is to characterize striatal and extrastriatal dopamine D2 and D3 receptor binding potential in patients with TRD, non-resistant MDD and healthy controls. The primary hypothesis is that TRD patients will exhibit greater D2/D3 receptor binding potential compared to non-TRD patients in the following regions of interest: dorsolateral prefrontal cortex, orbitofrontal cortex, and ventral striatum. Secondarily, non-TRD patients will also demonstrate increased binding potential compared to healthy controls in the same brain regions. Whole brain analyses will allow us to take an exploratory approach to other brain regions that may differentiate TRD from non-TRD patients. Participants will be assessed at St. Michael's Hospital (SMH) and the Centre for Addiction and Mental Health (CAMH), which are within a 10 minute driving distance of each other. There will be 3 study visits following written informed consent. Eligibility will be confirmed at a screening visit at SMH where demographic information, including age, sex, education, and medication history will be obtained, as well as the administration of a structured Mini-International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I diagnoses (Sheehan et al, 2015), and an HRSD-17. Within two weeks of the screening visit, participants will undergo a structural magnetic resonance imaging (MRI) scan at SMH prior to the positron-emission tomography (PET) scan at CAMH. The order of the PHNO scans will be counterbalanced.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: