February 15, 2022 Print
Mental illness remains one of the most complex group of diseases. At the Brain Dynamics Centre we are constantly working towards developing new diagnostic tools and better personalized treatments.
The study “Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder” aims to understand the brain patterns, cognition, and behavior in patients with major depressive disorder who show clinical improvement while on adjunctive treatment with Agomelatine. The study will collect data from electroencephalography (EEG), cognitive testing, genetic sampling, and wearable devices. This study will examine the electrical activity of the brain to identify specific brain activation patterns and their responses to treatment with commercially available Agomelatine.
To be eligible for this study:
• You must have moderate to severe Major Depressive Disorder
• You must be 18 to <75 years of age.
• For the current depressive episode, you must have failed < 3 prior antidepressant medications, and must remain on their last failed currently prescribed antidepressant medication.
Exclusion criteria:
• Diagnosis of bipolar disorder or psychotic disorder
• Concurrent use of antipsychotics or mood stabilizers
• Hepatic impairment
• Pregnant or breastfeeding
• Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
• Concurrent participation in any other research study aimed at treating mental illness and involving an investigational product or device
Patients will be referred back to their treating clinicians after their participation in the study.
All participants will receive study drug (agomelatine) paid for by the sponsor during the study and for 6 months after the end of the study along with reimbursement for reasonable expenses related to participation in the study. The study is approved by Western Sydney Local Health District - Human Research Ethics Committee.
Please contact the Clinical Trial Coordinator Ana Rita Barreiros on +61(2)86273319 or
ana.barreiros@sydney.edu.au to discuss any questions.