An Innovative Master Platform for Clinical Trials in Mood Disorders

Официальное название

Enabling Neuroscience Research Approaches for Brain, feeLings and Emotions (ENABLE): An Innovative Platform for Clinical Trials in Mood Disorders

Обзор

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.

Подробное описание

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 question will be included in the informed consent process asking participants whether they agree to be contacted about future clinical trials associated with the ENABLE platform.

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); complete a cognitive task (CNS Vital Signs) and are given an actigraphy device to wear for two weeks.

Первичные конечные точки

• Rate of participation in the master trial platform [Срок оценки: 31st March 2026]

Критерии участия

Критерии включения

Patients:

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

Критерии включения

Healthy Comparison (HC) Participants:

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 9 центров

• University of Calgary — Calgary
• University of British Columbia — Vancouver
• Nova Scotia Health Authority — Halifax
• McMaster University — Hamilton
• Queen's University — Kingston
• University of Ottawa — Ottawa
• University Health Network — Toronto
• Centre for Addiction and Mental Health — Toronto
• … и ещё 1 центр

Идентификаторы

NCT: NCT06408012 · CAN-BIND-18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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