An Innovative Master Platform for Clinical Trials in Mood Disorders (ENABLE)

St. Joseph's Healthcare Hamilton

Status: Enrolling

Conditions: Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06408012

CAN-BIND-18

Details and patient eligibility

About

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.

Full 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 and/or 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients:

1. 16 years of age or older.
2. Meet criteria for bipolar or depressive disorders as defined by DSM-5.
3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Inclusion Criteria

Healthy Comparison (HC) Participants:

1. 16 years of age or older.
2. No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions.
3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.