Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial

Exclusion Criteria

• •1. History of allergic reaction or hypersensitivity to tipepidine hibenzate.
• •2. Patients who have not been informed of having the disease at the time of informed consent.
• •3. Diagnosis of any of the following diseases based on the DSM-5 criteria. Autism Spectrum Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Neurocognitive Disorders, Substance Related and Addictive Disorders, Feeding and Eating Disorders, Personality Disorders, Paraphilic Disorders.
• •4. currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study.
• •5. currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study.
• •6. currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study.
• •7. Somatic disorder which requires severe body management or severe meal management.
• •8. participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention).
• •9. planning change of treatment because of unstable neurological manifestations or somatic symptoms.
• •10. History of suicidal ideation within the past year.
• •11. pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study.
• •12. Other clinically significant reasons for exclusion by investigators.