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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00057408 |
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Date of registration:
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01/04/2003 |
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Primary sponsor: |
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Public title:
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A Controlled Study of Olanzapine in Children With Autism
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Scientific title:
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A Controlled Study of Olanzapine in Children With Autism |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00057408 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard P Malone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Drexel University College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males and females, Aged between 3 and 12 years.
2. Autistic disorder - DSM-IV criteria.
3. A score of at least moderately impaired on the CGI-Severity item.
4. Clinical judgment that medication treatment for autism is indicated.
Exclusion Criteria:
1. Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD,
NOS.
2. Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
3. Major depressive disorder (DSM-IV).
4. Bipolar disorder (DSM-IV).
5. History of psychoactive drug in the previous 2 weeks prior to phase 1.
6. A history of treatment with olanzapine for a cumulative period of greater than 2
weeks prior to entering phase 1.
7. Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure
disorder (seizure disorder that is not controlled by anti-epileptic medication - a
child who is seizure free for a period of 6 months on a stable dose of antiepileptic
drug would be considered controlled), or diabetes mellitus.
8. Children with a known medical cause for autistic disorder.
9. Abnormal fasting blood glucose or history of diabetes.
10. Baseline body mass index (BMI) greater than the 90th percentile for age and gender
(CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain).
11. Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc
values >450.
12. Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).
Age minimum:
3 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autistic Disorder
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Intervention(s)
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Drug: olanzapine (Zyprexa)
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Drug: Placebo
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Primary Outcome(s)
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Children's Psychiatric Rating Scale
[Time Frame: Weekly]
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Secondary Outcome(s)
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Aberant Behavior Checklist
[Time Frame: Weekly]
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Abnormal Involuntary Movement Scale
[Time Frame: Weekly]
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Clinical Global Impressions
[Time Frame: Weekly]
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Neurological Rating Scale
[Time Frame: Weekly]
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Olanzapine Untoward Effects Checklist
[Time Frame: Weekly]
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Treatment Emergent Symptoms Scale
[Time Frame: Weekly]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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