NCT00208533

Brief Summary

This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12 to 18 years, diagnosed with autism. Children who qualify for the study will be treated with aripiprazole for 6 weeks. Treatment is provided at no cost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2011

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

7.8 years

First QC Date

September 13, 2005

Last Update Submit

July 27, 2018

Conditions

Autism

Keywords

AutismPervasive developmental disorderAripiprazoleAntipsychotic medicationAdolescents

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions

    Week 6

Study Arms (1)

1 Open Label

OTHER

Open Label Aripiprazole

Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Aripiprazole 5 mg to 30mg, individually titrated

Also known as: Abilify
1 Open Label

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of autism (DSM-IV) made by a boarded child and adolescent psychiatrist.
  • Males and females.
  • Aged 12 to 18 years.
  • Clinical judgment that medication treatment for autism is indicated.

You may not qualify if:

  • Major medical problems including cardiac, liver, endocrine, or renal diseases.
  • Uncontrolled seizures.
  • Baseline QTC greater than 425 msec.
  • Concomitant treatment with psychotropic medication.
  • History of prior exposure to aripiprazole.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine at Friends Hospital

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Conditions

Autistic DisorderChild Development Disorders, Pervasive

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Richard P Malone, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
The care provider is unaware of the treatment arm the child is enrolled.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2004

Primary Completion

November 16, 2011

Study Completion

November 16, 2011

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

No sharing plan

Locations

US(1)