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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.
 
ClinicalTrials.gov Identifier: NCT00221962
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 15, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date December 15, 2014
Study Start Date  ICMJE April 2005
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Effectiveness and cognitive effects [ Time Frame: 6 weeks ]
To examine effectiveness and cognitive effects during open-label pilot
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
Official Title  ICMJE The Cognitive Effects of Aripiprazole in Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE Drug: Aripiprazole
Open label
Other Name: As previously described.
Study Arms  ICMJE 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.
Intervention: Drug: Aripiprazole
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2013)
23
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00221962
Other Study ID Numbers  ICMJE cognition
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert L Findling, MD, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Robert L Findling, MD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP