Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)

Completed · Phase 4

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

To look at the cognitive effects of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.

Key facts

Study ID

NCT00221962

Run by

University Hospitals Cleveland Medical Center

People needed

23

Starts

2005-04-01

Expected to finish

2007-04-01

Last updated by the study team

2014-12-15

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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