Status:
COMPLETED
Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-12 years
Phase:
PHASE4
Brief Summary
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 childr...
Detailed Description
This will be a prospective, open-label, 6-week trial of APZ in outpatient children 8-12 years of age with a primary diagnosis of ADHD free of other major psychopathology. The six-week treatment phase ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00221962
Start Date
April 1 2005
End Date
April 1 2007
Last Update
December 15 2014
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106