Phase 3
Completed N=25
Study of Paliperidone ER in Adolescents and Young Adults With Autism
Source: ClinicalTrials.gov NCT00549562 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: The Clinical Global Impression-Improvement(CGI-I) — 1.8 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Clinical Global Impression-Improvement(CGI-I) |
1.8 | — |
| PRIMARY The Aberrant Behavior Checklist |
12.6; 17.4; 7.6; 6.4; 3.4 | — |
| SECONDARY The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders |
11.9 | — |
| SECONDARY The Social Responsiveness Scale |
100.9 | — |
| SECONDARY The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain |
19.0; 6.4; 25.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00549562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.