Study of Paliperidone ER in Adolescents and Young Adults With Autism
This study has been completed.
Sponsor:
Indiana University School of Medicine
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00549562
First received: October 25, 2007
Last updated: May 14, 2015
Last verified: May 2015
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Purpose
This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism |
Drug: Paliperidone ER |
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: | A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Primary Outcome Measures:
- The Irritability subscale of the Aberrant Behavior Checklist (ABC) will be used as the caregiver-rated primary outcome measure. The Clinical Global Impression-Improvement(CGI-I) will be included as a primary outcome measure. [ Time Frame: At every visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary outcome measures include the all the other subscales of the ABC, the Vineland Adaptive Behavior Scales,the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Social Responsiveness Scale. [ Time Frame: To be done at baseline and endpoint ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Paliperidone ER
8-Week Open-Label
|
Drug: Paliperidone ER
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Other Name: Invega
|
Eligibility| Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females between ages of 12 and 21 years
- 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:
- Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, Fragile X Syndrome, Tuberous Sclerosis
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549562
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549562
Locations
| United States, Indiana | |
| Riley Child & Adolescent Psychiatry Clinic- Riley Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
Indiana University School of Medicine
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
| Principal Investigator: | Kimberly A Stigler, MD | Indiana Univerity School of Medicine |
More Information
| Responsible Party: | Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00549562 History of Changes |
| Other Study ID Numbers: | 0709-24 R076477-AUT-4002 |
| Study First Received: | October 25, 2007 |
| Last Updated: | May 14, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Autistic Disorder |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Paliperidone Palmitate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on September 30, 2016