Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD

Exclusion Criteria

• •Psychiatric comorbidity except Oppositional Defiant Disorder \[ODD\], Simple Phobia, and dysthymia (unless ongoing medication treatment is required);
• •Currently a suicide risk, has previously made a suicide attempt or has a prior history of suicidal behavior;
• •Has failed treatment with an adequate trial of an alpha-2 adrenergic agonist;
• •Known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride.
• •Children may not:
• •be treated with systemic medication for a medical or psychiatric illness that have CNS effects or affect cognitive function;
• •have a known history or presence of structural cardiac abnormalities, exercise-related cardiac events, or clinically significant bradycardia;
• •have orthostatic hypotension or a known history of hypertension;
• •have an abnormal ECG that is deemed clinically significant;
• •have a history of alcohol or other substance abuse or dependence within the last 6 months;
• •use any medications that affect BP or heart rate (excluding the subject's current ADHD medication at screening);
• •use another investigational medicinal product or participation in a clinical study within 30 days prior to the baseline visit;
• •be significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts;
• •have body weight of less than 25kg;
• •have a clinically important abnormality on urine drug and alcohol screen (excluding the subject's current ADHD stimulant, if applicable);
• •be female and currently pregnant or lactating;
• •have symptoms indicative of a primary sleep disorder.
• •have braces or other metal permanently placed within their body.
• •be too anxious to tolerate the fMRI procedure, or be claustrophobic.