---
title: "Can a 10-Item PANSS Work as Well in Pediatric Trials?"
description: "Dropout rates of 15-30% in AOM trials threaten regulatory submissions. Evidence-based strategies to improve participant retention in anti-obesity trials."
type: article
version: 1
version_id: "5d77ec53-6ef9-4e23-b3a9-588e72840414"
generated_at: "2026-06-19T09:31:55.842Z"
author: "Signant Health"
date_published: "2026-06-19T09:30:14.000Z"
date_modified: "2026-06-19T09:30:14.944Z"
language: en
reading_time: "12 min"
word_count: 2360
keywords: ["Can a 10", "Item PANSS Work as Well in Pediatric Trials?", "Key Points"]
url: "https://signanthealth.com/resources/can-a-10-item-panss-work-as-well-in-pediatric-trials"
---

# Can a 10-Item PANSS Work as Well in Pediatric Trials?

> Dropout rates of 15-30% in AOM trials threaten regulatory submissions. Evidence-based strategies to improve participant retention in anti-obesity trials.

## Key Takeaways

- Key Points
- AUTHOR BIO

[Back to Resource Hub](https://signanthealth.com/resources) Article

# Can a 10-Item PANSS Work as Well in Pediatric Trials?

[Signant Health](https://signanthealth.com/resources/author/signant-health)

Jun 19, 2026

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A 10-item version of the Positive and Negative Syndrome Scale (PANSS) detects drug versus placebo treatment effects in adolescents with [schizophrenia](/science/indication/schizophrenia) as well as the standard 30-item adult version, across three independent randomized controlled trials. This finding, now replicated in a second placebo-controlled pivotal registration trial, has direct implications for how sponsors design assessment strategies in pediatric psychopharmacology studies. 

## Key Points 

-   The 10-item PANSS, derived from the NIMH-funded TEOSS pediatric dataset, has now been validated in three independent randomized trials involving different participants, countries, raters, and pharmacological interventions.
-   Secondary analysis of the placebo-controlled aripiprazole pivotal trial (N=302, ages 13 to 17) found the 10-item version produced treatment effect estimates essentially identical to those of the 30-item version, with eta-squared values for time ranging from 0.22 to 0.23.
-   The 10-item version reduces the PANSS interview by two-thirds, lowering burden on adolescent participants, caregivers, and raters while maintaining the reliability, validity, and treatment sensitivity of the full-length scale.
-   Content coverage was strong, with an observed correlation of 0.87 between the PANSS10 and the full 30-item version at baseline, exceeding the projected correlation of 0.76 based on scale length alone.
-   The authors recommend the 10-item version for current clinical and psychopharmacology trial use, noting that researchers targeting symptoms not covered by the 10 items remain free to use the 20-item or full 30-item version.
-   The full peer-reviewed paper, published in European Child and Adolescent Psychiatry (doi: 10.1007/s00787-025-02681-1), contains the complete psychometric analyses, item response theory data, reliability benchmarks, and minimally important difference estimates not reproduced here.   

**Why It Matters Now: Pediatric Participants Carry the Cost of Poorly Optimized Assessments**   

An adolescent with schizophrenia participating in a clinical trial is managing a serious, often frightening illness while being asked to complete lengthy interviews at every study visit. Caregivers attend those visits alongside them. When a 30-item assessment instrument designed for adults is applied without question to pediatric populations, the burden is real, and the psychometric justification, as this research demonstrates, is not.   

The consequences of under-optimized assessments in pediatric trials extend beyond participant experience. Trials that are not designed to detect signal efficiently are, as the authors state directly, a waste of the good-faith efforts of participants, families, sponsors, regulators, and the field.    

The replication crisis affecting psychology and medicine has made this point sharper: findings based on a single study carry less weight than findings replicated across independent, placebo-controlled, multi-center trials with different drugs, different raters, and different countries.   

This paper, published in European Child and Adolescent Psychiatry in March 2025, represents the third independent replication of the shortened PANSS in pediatric schizophrenia trials. That replication standard is now met. For sponsors designing pediatric CNS studies today, the case for continuing to use the full 30-item adult version without evaluation requires justification.   

**What the Evidence Shows: Three Trials, Consistent Findings, One Recommendation**   

Sponsors and investigators have historically defaulted to the 30-item PANSS in pediatric trials for a defensible reason: it is the established standard, it has the regulatory track record, and departing from it without strong psychometric evidence carried risk. That barrier no longer holds in the same way.   

The shortened PANSS versions were first derived from the [NIMH TEOSS pediatric dataset by Findling, Youngstrom, and colleagues](https://pubmed.ncbi.nlm.nih.gov/36526163/), published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2023. They were subsequently replicated in the paliperidone pivotal registration trial for adolescents with schizophrenia. The present paper, co-authored by Joan Busner and David G. Daniel of Signant Health alongside researchers at Virginia Commonwealth University, Nationwide Children's Hospital, The Ohio State University, and the University of North Carolina at Chapel Hill, confirms those findings in a third wholly independent dataset: the Otsuka aripiprazole pivotal trial accessed through Vivli.   

Across all three trials, the 10-item and 20-item versions demonstrated reliability, convergent validity with CGI-S scores, and sensitivity to treatment change equivalent to the full 30-item version. Average discrepancy between short and full-length scores was negligible, at less than 0.1 points on average, and smallest within the score range most commonly used as an enrollment criterion in registration trials. The authors' current recommendation is clear: use the 10-item version. The full paper contains precision benchmarks, minimally important difference estimates, and item response theory analyses that support applying this recommendation to individual program design decisions.

> "Pediatric clinical trials that are not optimized for detecting signal are in many ways a waste of precious human resources and a betrayal of the good faith efforts of participants, families, sponsors, regulators, and ultimately the field at large."  - *Joan Busner, PhD, Clinical Vice President, Signant Health; European Child and Adolescent Psychiatry, 2025* 
> 
> * * *

### Can complex cognitive assessments like the ADAS-Cog be administered remotely in dementia trials?

Yes, with specific conditions met. Copyright holder approval is required, as remote administration was not part of the original scale design. Raters need dedicated training on remote assessment hygiene. Physical elements requiring in-person assistance, such as reorienting materials, can be delegated to an on-site proxy. Endpoint reliability analysis in an 1,800-participant study confirmed remote quality on par with in-person administration.

### What are the main risks of remote assessment in long-duration dementia studies?

The primary risks include internet connectivity gaps, inconsistent screen sizes across participant homes, participant and caregiver technology literacy, progressive cognitive decline reducing participants' ability to navigate remote systems over an 18-month or longer study, and the need to return physical source documents, such as drawings, to the site. Each requires protocol-level planning before the study starts.

### How should sponsors decide between hybrid and fully decentralized models for dementia trials?

The decision should be driven by which scale elements require physical presence and cannot be delegated to an on-site proxy, the availability of a mobile nurse or equivalent for in-home visits, the expected duration of the study relative to anticipated cognitive decline in the participant population, and whether key visits at defined timepoints require in-clinic attendance for clinical or regulatory reasons.

## AUTHOR BIO 

Name: Joan Busner  
Title and Credentials: PhD, Clinical Vice President at Signant Health   
Bio: Joan Busner, PhD, is Clinical Vice President at Signant Health, with over 35 years of experience as an academic psychiatric researcher and psychopharmacology principal investigator. She founded and directed two university psychiatric clinical trials units and served continuously on University Institutional Review Boards for 20 years. At Signant, she holds scientific and clinical responsibility for studies in mood, anxiety, pediatrics, and rare and orphan diseases.  

She is the corresponding author of this paper, co-authored with David G. Daniel, MD, Executive Advisor, Schizophrenia at Signant Health and Clinical Professor of Psychiatry at George Washington University, alongside Eric A. Youngstrom, Joshua A. Langfus, and Robert L. Findling from Nationwide Children's Hospital, The Ohio State University, and the University of North Carolina at Chapel Hill. 

[READ THE ARTICLE](https://signanthealth.com/hubfs/Marketing%20Assets/Articles/Article%20-%20Replicating%20and%20Extending%20Reliability%2c%20Criterion%20Validity%2c%20and%20Treatment%20Sensitivity%20-%20ECAP%20-%20Busner%20Daniel%20-%202025.pdf)

Designing PANSS assessment strategy for an upcoming pediatric CNS or schizophrenia program? [Speak to Joan Busner, PhD, or David Daniel, MD](/contact-sales), about shortened scale validation, rater training, and endpoint reliability for pediatric psychopharmacology trials. 

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## Frequently Asked Questions

### Can complex cognitive assessments like the ADAS-Cog be administered remotely in dementia trials?

Yes, with specific conditions met. Copyright holder approval is required, as remote administration was not part of the original scale design. Raters need dedicated training on remote assessment hygiene. Physical elements requiring in-person assistance, such as reorienting materials, can be delegated to an on-site proxy. Endpoint reliability analysis in an 1,800-participant study confirmed remote quality on par with in-person administration. Yes, with specific conditions met. Copyright holder approval is required, as remote administration was not part of the original scale design. Raters need dedicated training on remote assessment hygiene. Physical elements requiring in-person assistance, such as reorienting materials, can be delegated to an on-site proxy. Endpoint reliability analysis in an 1,800-participant study confirmed remote quality on par with in-person administration. What are the main risks of remote assessment in long-duration dementia studies?
        
      
      
        
          The primary risks include internet connectivity gaps, inconsistent screen sizes across participant homes, participant and caregiver technology literacy, progressive cognitive decline reducing participants' ability to navigate remote systems over an 18-month or longer study, and the need to return physical source documents, such as drawings, to the site. Each requires protocol-level planning before the study starts.

### What are the main risks of remote assessment in long-duration dementia studies?

The primary risks include internet connectivity gaps, inconsistent screen sizes across participant homes, participant and caregiver technology literacy, progressive cognitive decline reducing participants' ability to navigate remote systems over an 18-month or longer study, and the need to return physical source documents, such as drawings, to the site. Each requires protocol-level planning before the study starts. The primary risks include internet connectivity gaps, inconsistent screen sizes across participant homes, participant and caregiver technology literacy, progressive cognitive decline reducing participants' ability to navigate remote systems over an 18-month or longer study, and the need to return physical source documents, such as drawings, to the site. Each requires protocol-level planning before the study starts. How should sponsors decide between hybrid and fully decentralized models for dementia trials? 
        
      
      
        
          The decision should be driven by which scale elements require physical presence and cannot be delegated to an on-site proxy, the availability of a mobile nurse or equivalent for in-home visits, the expected duration of the study relative to anticipated cognitive decline in the participant population, and whether key visits at defined timepoints require in-clinic attendance for clinical or regulatory reasons.

### How should sponsors decide between hybrid and fully decentralized models for dementia trials?

The decision should be driven by which scale elements require physical presence and cannot be delegated to an on-site proxy, the availability of a mobile nurse or equivalent for in-home visits, the expected duration of the study relative to anticipated cognitive decline in the participant population, and whether key visits at defined timepoints require in-clinic attendance for clinical or regulatory reasons. The decision should be driven by which scale elements require physical presence and cannot be delegated to an on-site proxy, the availability of a mobile nurse or equivalent for in-home visits, the expected duration of the study relative to anticipated cognitive decline in the participant population, and whether key visits at defined timepoints require in-clinic attendance for clinical or regulatory reasons.

---

## About This Content

**Source:** [Can a 10-Item PANSS Work as Well in Pediatric Trials?](https://signanthealth.com/resources/can-a-10-item-panss-work-as-well-in-pediatric-trials)
**Author:** Signant Health
**Published:** June 19, 2026

*This content is provided for informational purposes. Please visit the original source for the most up-to-date information.*