Long-Term Olanzapine Treatment in Children With Autism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183404
First received: September 13, 2005
Last updated: April 29, 2009
Last verified: April 2009

September 13, 2005
April 29, 2009
September 2004
July 2009   (final data collection date for primary outcome measure)
Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
Effectiveness of olanzapine, as measured by the Children's Psychiatric Rating Scale
Complete list of historical versions of study NCT00183404 on ClinicalTrials.gov Archive Site
  • Aberrant Behavior Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
  • Clinical Global Impressions [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
  • Treatment Emergent Symptoms Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Olanzapine Untoward Effects Checklist [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Abnormal Involuntary Movement Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Neurological Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: Yes ]
  • Aberrant Behavior Checklist
  • Clinical Global Impressions
Not Provided
Not Provided
 
Long-Term Olanzapine Treatment in Children With Autism
Long-Term Olanzapine Treatment in Children With Autism

This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.

Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.

This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism
Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other Name: Open Olanzapine
1
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of autism
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Uncontrolled seizure disorder
  • Medical illness other than autism affecting the whole body
  • Obesity
  • History of psychosis
  • Impairment of voluntary movement
  • History of olanzapine treatment
Both
3 Years to 12 Years
No
Contact: Richard P. Malone, MD 215-831-4058 rmalone@drexelmed.edu
Contact: Melissa Lech, BSN 215-831-4058 mlech@drexelmed.edu
United States
 
NCT00183404
R01 MH073524, DDTR B2-NDA
Yes
Richard P. Malone, MD, Drexel University College of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
National Institute of Mental Health (NIMH)
April 2009

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