Long-Term Olanzapine Treatment in Children With Autism
Recruitment status was Recruiting
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Purpose
This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism |
Drug: Olanzapine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long-Term Olanzapine Treatment in Children With Autism |
- Children's Psychiatric Rating Scale [ Time Frame: Measured monthly throughout the study ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
|
Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other Name: Open Olanzapine
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Richard P. Malone, MD | 215-831-4058 | rmalone@drexelmed.edu |
| Contact: Melissa Lech, BSN | 215-831-4058 | mlech@drexelmed.edu |
| United States, Pennsylvania | |
| Drexel University College of Medicine at Friends Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19124 | |
| Contact: Richard P. Malone, MD 215-831-4058 rmalone@drexelmed.edu | |
| Contact: Melissa Lech, BSN 215-831-4058 mlech@drexelmed.edu | |
| Principal Investigator: Richard P. Malone, MD | |
| Sub-Investigator: Mary A. Delaney, MD | |
| Principal Investigator: | Richard P. Malone, MD | Drexel University College of Medicine |
More Information
No publications provided
| Responsible Party: | Richard P. Malone, MD, Drexel University College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00183404 History of Changes |
| Other Study ID Numbers: | R01 MH073524, DDTR B2-NDA |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Drug Treatment Child Olanzapine |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013