Patients
Psychiatric, Autism Spectrum Disorder, Psychotic Disorders, Obsessive-Compulsive, Bipolar, depressive disorder, depressive, MDD, Schizophrenia, Attention-Deficit/Hyperactivity Disorder, DSM-5, Bipolar Disorder
DISORDERS, LONG QT SYNDROME, DISORDERS, FEEDING, DISORDERS
This study included patients aged 12–17 years with a diagnosis of MDD or persistent depressive disorder with a current major depressive episode based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, The main exclusion criteria were as follows: “according to DSM-5, patients with Intellectual Disability, Autism Spectrum Disorder, Attention-Deficit/Hyperactivity Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and Related Disorders, Feeding and Eating Disorders, Disruptive, Impulse-Control, and Conduct Disorders, Substance Use disorders (excluding caffeine), or Personality Disorders,” “First-degree relatives with Bipolar Disorder,” “Patients with long QT syndrome,” “Based on Columbia-Suicide Severity Rating Scale (C-SSRS), patients with a history of suicide attempt or interrupted suicide attempt within 1 year,” “patients with high risk of suicide,” “patients receiving MAO inhibitors within 2 weeks,” “patients receiving antipsychotics within 4 weeks (within 6 months for depots),” “patients receiving electroconvulsive therapy or high light therapy,” and “Pregnant, lactating, or potentially pregnant patients.”This study was approved in advance by the Institutional Review Boards of all the participating medical institutions in Japan and was conducted in accordance with the ethical principles based on the Declaration of Helsinki and local regulatory requirements, including the Good Clinical Practice. Informed consent was obtained from proxies, and informed assent from the patients themselves was obtained.