Identify Peripheral Biomarkers of Symptomatology, Neurocognitive Functions, and Medication Response in ADHD

This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder focused on measuring Attention-deficit/hyperactivity disorder,, symptomatology,, neurocognitive endophenotype,, medication response Read More

Inclusion Criteria:

• Patients will be outpatients who are between 7 and 16 years of age.
• Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 4th edition (DSM-IV) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
• Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score > 4 at Visit 1.
• Patients must be psychotropic medication-naïve. Patients will be considered to be medication-naïve if they have never received medications specifically to treat ADHD.
• Patients must have laboratory results, including serum chemistries, hematology, and urine analysis showing no significant abnormalities and no clinical information that should preclude a patient's participation at study entry. A patient with a significant abnormal laboratory result may enter the study if, after appropriate medical evaluation, the result does not indicate a serious medical condition that in the investigator's judgment would preclude participation.
• Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
• Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
• Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.

Exclusion Criteria:

• Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, Asperger's disorder, or pervasive developmental disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
• Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
• Patients have been at serious suicidal risk, determined by the investigator.
• Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions.
• Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over- the-counter medication in a manner that the investigator considers indicative of abuse.
• Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
• Patients who are likely to need psychotropic medications apart from methylphenidate, including Chinese medicine or health-food supplements that have central nervous system activity.