NCT00221962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 15, 2014

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

September 16, 2005

Last Update Submit

December 12, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

  • Effectiveness and cognitive effects

    To examine effectiveness and cognitive effects during open-label pilot

    6 weeks

Study Arms (1)

Open label treatment with aripiprazole

OTHER

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

Interventions

AripiprazoleDRUG

Open label

Also known as: As previously described.
Open label treatment with aripiprazole

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 18759644DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert L Findling, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Child and Adolescent Psychiatry

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

December 15, 2014

Record last verified: 2013-06

Locations

US(1)