Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408012
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
An Innovative Master Platform for Clinical Trials in Mood Disorders
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Enabling Neuroscience Research Approaches for Brain feeLings and Emotions ENABLE An Innovative Platform for Clinical Trials in Mood Disorders
Status:
RECRUITING
Status Verified Date:
2024-05
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:
ENABLE
Brief Summary:
Mood disorders such as depression and bipolar disorder affect over 350 million people around the world While several effective treatments exist it is often difficult to match the right treatment to an individual person Repeated efforts to find the right treatment contribute to poor functioning low quality of life and prolongs the time it takes to get well Most areas of medicine are able to use biomarkers or clinical tests blood tests or imaging to help diagnose and treat illness The search for biomarkers in mood disorders is advancing but one roadblock to progress is the lack of large standardized studies of mood disorders that are needed to accurately identify biomarkers The aim of the ENABLE platform is to provide the Canadian neuroscience community a standardized way of collecting biomarker data from individuals with a range of mood disorders symptoms In addition this master clinical trial platform framework will provide a pool of participants who can be recruited into biomarker-based clinical trials
Detailed Description:
The ENABLE platform offers to the Canadian neuroscience community 1 standardized data collection methods with deep clinical and neurobiological phenotyping of individuals across the spectrum of mood disorder symptoms 2 a recruitment pool for efficient launch of clinical trials and 3 an open source of clinical and neurobiological data for discovery analyses andor grant applications
The assessments have been categorized into a tiered system where participants must consent to complete tier 1 items in order to be enrolled in the platform Tier 2 items will be optional measures the absence of these measures will not compromise the inclusion in the platform A separate written informed consent to be contacted regarding participation in future clinical trials associate with the ENABLE platform will also be offered
At tier 1 individuals complete clinical assessments clinician administered and self-report and during their tier 2 they provide blood undergo neuroimaging procedures MRI and EEG and are given an actigraphy device to wear for two weeks
The assessments have been categorized into a tiered system where participants must consent to complete tier 1 items in order to be enrolled in the platform Tier 2 items will be optional measures the absence of these measures will not compromise the inclusion in the platform A separate written informed consent to be contacted regarding participation in future clinical trials associate with the ENABLE platform will also be offered
At tier 1 individuals complete clinical assessments clinician administered and self-report and during their tier 2 they provide blood undergo neuroimaging procedures MRI and EEG and are given an actigraphy device to wear for two weeks
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