Study of Paliperidone ER in Adolescents and Young Adults With Autism
NCT ID: NCT00549562
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2007-11-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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Paliperidone ER
8-Week Open-Label
Paliperidone ER
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Interventions
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Paliperidone ER
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tanner Sage III or IV (post-pubertal)
* Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of autism
* Outpatient
* Ability to swallow pills
* Antipsychotic medication-free for at least 2 weeks
* Score of 4 or more on the Clinical Global Impressions Severity Scale
* Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale
* Mental age of 18 months or greater based on testing
* Subjects must be in good physical health
Exclusion Criteria
* A significant medical condition
* An active seizure disorder
* Females who are pregnant
* Evidence of a prior adequate trial of paliperidone ER
* History of neuroleptic malignant syndrome
* Hypersensitivity to paliperidone ER
12 Years
21 Years
ALL
No
Sponsors
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Ortho-McNeil Janssen Scientific Affairs, LLC
INDUSTRY
Indiana University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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David Dunn, MD
Role: STUDY_DIRECTOR
Indiana Univerity School of Medicine
Locations
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Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
Indianapolis, Indiana, United States
Countries
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References
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Stigler KA, Mullett JE, Erickson CA, Posey DJ, McDougle CJ. Paliperidone for irritability in adolescents and young adults with autistic disorder. Psychopharmacology (Berl). 2012 Sep;223(2):237-45. doi: 10.1007/s00213-012-2711-3. Epub 2012 May 3.
Other Identifiers
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R076477-AUT-4002
Identifier Type: -
Identifier Source: secondary_id
0709-24
Identifier Type: -
Identifier Source: org_study_id
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