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NCT00549562COMPLETEDanonymous

A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism

Sponsor

Source record

Indiana University

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

Dopamine D2 receptor antagonist

Indication / condition

AI-normalized

Autism

Intervention

Source record

Paliperidone ER

Source & freshness

Source record

NCT ID

NCT00549562

Original source

ClinicalTrials.gov

Source last updated

May 16, 2017

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00549562

Title

A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism

Sponsor

Indiana University

Status

COMPLETED

Phase

Phase 3

Condition raw

Autism

Condition normalized

Autism

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Dopamine D2 receptor antagonist

Target normalized

Dopamine D2 receptor antagonist

Interventions

Paliperidone ER

Public preview

Source record

The study investigates the efficacy and tolerability of paliperidone ER in treating aggression, self-injury, and irritability in adolescents and young adults with autism. Given the increasing prevalence of autism spectrum disorders and the limited treatment options available, successful outcomes could position paliperidone ER as a key therapeutic option in this niche market. The collaboration with Ortho-McNeil Janssen Scientific Affairs, LLC suggests potential for further commercialization and distribution. However, competition from other antipsychotics and emerging therapies targeting similar symptoms must be monitored closely.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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