Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
Attention Deficit Hyperactivity Disorder
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD
Eligibility Criteria
Inclusion Criteria: Outpatients ages 8-12 years (inclusive) Currently meets DSM-IV (American Psychiatric Association, 1994) criteria for a primary diagnosis of ADHD (either predominantly inattentive type or combined type) based on the results of semi-structured diagnostic assessment (K-SADS-PL)(Kaufman et al., 1997) and based on the results of a clinical interview with a child and adolescent psychiatrist Patients, who in the investigator's opinion, have substantial symptoms of ADHD for which pharmacotherapy is indicated Has a guardian who has provided written informed consent to participate in this trial Has provided written informed assent to participate in this study Exclusion Criteria: Patients who have a history of intolerance to APZ at a dose of 5 mg/day Patients with a history of APZ allergy or hypersensitivity to APZ Patients with an active or prior neurological/medical disorder for which treatment with APZ would be contraindicated (such as tardive dyskinesia or neuroleptic malignant syndrome) Patients with clinical evidence of autistic disorder, Rett's syndrome or Asperger's syndrome Patients with any bipolar spectrum disorder Patients with any schizophrenia spectrum disorder Patients with conduct disorder Patients with post-traumatic stress disorder or generalized anxiety disorder Patients with a substance abuse disorder Females who are sexually active, pregnant or lactating Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months Patient taking psychotropic agents within one week of baseline (3 days for psychostimulants, 2 weeks for fluoxetine) Patients with evidence of mental retardation (I.Q. < 70) based on the results of the Peabody Picture Vocabulary Test- III (PPVT-III)(Dunn and Dunn, 1981) Patients who have a general medical or neurological condition that could interfere with the interpretation of the clinical response to APZ treatment Patients who are unable to swallow pills or capsules Patients for whom the need for hospitalization during the course of the study appears likely
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Other
Open label treatment with aripiprazole
After 1-3 week screening phase, entered six week open trial of aripiprazole initiated at 2.5mg/day. DOsing was increased weekly in 2.5mg increments in order to reach maximum dose of 10mg/d.