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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00221962
First received: September 16, 2005
Last updated: June 26, 2013
Last verified: June 2013
  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: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Effectiveness and cognitive effects [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    To examine effectiveness and cognitive effects during open-label pilot


Enrollment: 23
Study Start Date: April 2005
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Aripiprazole
Open label
Other Name: As previously described.

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:

  1. Outpatients ages 8-12 years (inclusive)
  2. 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
  3. Patients, who in the investigator's opinion, have substantial symptoms of ADHD for which pharmacotherapy is indicated
  4. Has a guardian who has provided written informed consent to participate in this trial
  5. Has provided written informed assent to participate in this study

Exclusion Criteria:

  1. Patients who have a history of intolerance to APZ at a dose of 5 mg/day
  2. Patients with a history of APZ allergy or hypersensitivity to APZ
  3. 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)
  4. Patients with clinical evidence of autistic disorder, Rett's syndrome or Asperger's syndrome
  5. Patients with any bipolar spectrum disorder
  6. Patients with any schizophrenia spectrum disorder
  7. Patients with conduct disorder
  8. Patients with post-traumatic stress disorder or generalized anxiety disorder
  9. Patients with a substance abuse disorder
  10. Females who are sexually active, pregnant or lactating
  11. Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
  12. Patient taking psychotropic agents within one week of baseline (3 days for psychostimulants, 2 weeks for fluoxetine)
  13. 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)
  14. Patients who have a general medical or neurological condition that could interfere with the interpretation of the clinical response to APZ treatment
  15. Patients who are unable to swallow pills or capsules
  16. Patients for whom the need for hospitalization during the course of the study appears likely
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
Responsible Party: Robert L Findling, MD, Director, Child and Adolescent Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00221962     History of Changes
Other Study ID Numbers: cognition
Study First Received: September 16, 2005
Last Updated: June 26, 2013
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 August 01, 2014