Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder) - Full Text View

Sponsor:	University Hospitals of Cleveland
Collaborator:	Bristol-Myers Squibb
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00221962

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: abilify	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Cognitive Effects of Aripiprazole in Children

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Estimated Enrollment:	20
Study Start Date:	April 2005

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 will be proceeded by a 1-3 week screening phase.

The study cohort will consist of 10 children with ADHD combined type and 10 children with ADHD predominantly inattentive type who complete the study.

Cognitive measures will be assessed prior to APZ therapy and after 6 weeks of APZ treatment.

Safety assessments and measures of ADHD symptomatology will be collected prior to and during APZ therapy.

While receiving APZ treatment, patients will be seen at baseline, Week 1,2,3,4, and 6.

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221962

Locations

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

Bristol-Myers Squibb

Investigators

Principal Investigator:

Robert L Findling, MD

University Hospitals of Cleveland

More Information

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Findling RL, Short EJ, Leskovec T, Townsend LD, Demeter CA, McNamara NK, Stansbrey RJ. Aripiprazole in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2008 Aug;18(4):347-54.

ClinicalTrials.gov Identifier:	NCT00221962 History of Changes
Other Study ID Numbers:	cognition
Study First Received:	September 16, 2005
Last Updated:	April 27, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

ADHD

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012