Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder

Exclusion Criteria11

• Age
• Aged 75 or older at the time of informed consent
• Treatment
• Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine and ciprofloxacin)
• Medical Conditions:
• Hepatic impairment (i.e. cirrhosis or active liver disease)
• Baseline serum transaminase levels exceed 3 times the upper limit of normal
• Pregnant or breastfeeding. If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence during the study, and for as long as they remain on sponsor provided agomelatine treatment.
• Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
• Other:
• Concurrent or recent participation in any another research study aimed at treating mental illness.