Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder — Mentis  

Autism Spectrum Disorder Clinical Trial

Official title: A Study to Preliminarily Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe abnormalities in the development of many basic psychological functions that are not normal for any stage in development. These abnormalities are manifested in sustained social impairment, speech abnormalities, and peculiar motor movements).

Clinical Trial Description

This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) and prospective (study following participants forward in time) study to determine JAKE in children and adults with ASD. The study will be conducted in 2 stages and each stage consists of 2 parts: Screening Phase (14 days), data collection Phase (Stage 1: 1 week and Stage 2: 4 weeks) and, stage 2 has follow-up Phase (up to 4 weeks post-data collection). The maximum study duration for each participant will not exceed 1 week for stage 1 and 8 weeks for stage 2. Primarily, the usability of JAKE as a system to monitor clinical outcomes in ASD will be assessed. Participants' safety will be monitored throughout the study. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

• NCT number: NCT02299700
• Study type: Observational
• Source: Janssen Research & Development, LLC
• Status: Completed
• Phase: N/A
• Start date: September 30, 2014
• Completion date: April 24, 2015