NCT00208559

Brief Summary

The purpose of this study is to see if the drug, ziprasidone, is effective in treating problems in adolescent associated with autism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2002

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months 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
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 17, 2010

Status Verified

June 1, 2010

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

June 15, 2010

Conditions

Autism

Keywords

AutismPervasive Developmental DisorderZiprasidoneAdolescents

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions

    Week 6

Secondary Outcomes (1)

  • Children's Psychiatric Rating Scale

    Baseline, Week 6

Study Arms (1)

1 Open Label

OTHER

Open Label

Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

Ziprasidone 40mg to 60mg per day, individually titrated

Also known as: Geodon
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.
  • History of seizure disorder or gross neurological deficit.
  • Baseline QTC greater than 425 msec.
  • Concomitant treatment with psychotropic medication.
  • History of prior exposure to ziprasidone.

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

ziprasidone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental Disorders

Study Officials

  • Richard P Malone, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2002

Primary Completion

June 1, 2005

Study Completion

August 1, 2006

Last Updated

June 17, 2010

Record last verified: 2010-06

Locations

US(1)