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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open label treatment with aripiprazole

Arm Description

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.

Outcomes

Primary Outcome Measures

Effectiveness and cognitive effects
To examine effectiveness and cognitive effects during open-label pilot

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
December 12, 2014
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00221962
Brief Title
Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
Official Title
The Cognitive Effects of Aripiprazole in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label treatment with aripiprazole
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
As previously described.
Intervention Description
Open label
Primary Outcome Measure Information:
Title
Effectiveness and cognitive effects
Description
To examine effectiveness and cognitive effects during open-label pilot
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Findling, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18759644
Citation
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. doi: 10.1089/cap.2007.0124.
Results Reference
derived

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

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