NCT04162522

Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

Integrated Biological Markers for the Prediction of Treatment Response in Depression: Validation Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a validation study that will replicate a completed study designed to assess biomarkers of treatment response to standard antidepressant treatment. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).

Detailed description

This is a multi-site study to replicate a previous multi-site, multi-platform study completed by the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study aims to validate the integrated array of markers of response and non-response to first line antidepressant treatments that were previously identified in the original aforementioned study. This will be accomplished through collection of clinical, neurophysiological, and molecular measures. This is not a study to evaluate efficacy of medications; medications in this study have been approved by Health Canada and are widely used for the treatment of MDD. In this study, individuals diagnosed with MDD in a current major depressive episode (MDE) will be treated with open-label escitalopram for 8 weeks. At week 8, participants will be assessed for treatment response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale score). Responders will continue on escitalopram for 8 more weeks. Non-responders will be given add-on brexpiprazole treatment, in addition to escitalopram, for 8 weeks. Over the 16 weeks, pariticipants will attend 7 clinical visits where they will complete clinical assessments (clinician administered and self-report) and cognitive tests; provide blood, urine, and stool samples; undergo neuroimaging procedures (MRI and EEG); and provide speech samples. At the end of the study, modeling methods will be used to integrate data from these measures to determine the features that best predict treatment outcome.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram	Participants are given escitalopram for 8 weeks. At week 8, those classified as responders will continue on escitalopram until the end of study.
DRUG	Brexpiprazole	Participants who are classified as non-responders are given 8 weeks add-on brexpiprazole, in addition to escitalopram, for the remainder of the study.

Timeline

• Start date: 2019-12-23
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-11-14
• Last updated: 2023-03-02

Locations

6 sites across 1 country: Canada