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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221962
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 15, 2014
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals Cleveland Medical Center

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 children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Aripiprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Cognitive Effects of Aripiprazole in Children
Study Start Date : April 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Effectiveness and cognitive effects [ Time Frame: 6 weeks ]
    To examine effectiveness and cognitive effects during open-label pilot

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221962

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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb
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Principal Investigator: Robert L Findling, MD University Hospitals Cleveland Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert L Findling, MD, Director, Child and Adolescent Psychiatry, University Hospitals Cleveland Medical Center Identifier: NCT00221962    
Other Study ID Numbers: cognition
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: June 2013
Keywords provided by Robert L Findling, MD, University Hospitals Cleveland Medical Center:
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists