# Clinical Trial Data Processing, Analysis, and Coordination Center (CT-DPACC) for Accelerating Medicines Partnership Schizophrenia (AMP SCZ) Project

> **NIH NIH U24** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $5,958,622

## Abstract

Every year ~100,000 young people in the US develop a first episode of psychosis and more than one million
have attenuated psychotic symptoms such as problems in perception, thinking and communication, which are
suggestive of a clinical high risk (CHR) for psychosis. These symptoms appear during critical periods in brain
development and have important ramifications for current and future function and morbidity. Of note, prior clinical
trials have not been successful in preventing psychosis onset, or other non-psychosis outcomes. There are many
reasons why. One is that clinical trials have been small, which is especially problematic given that attenuated
symptoms are heterogeneous, and stratification into meaningful subgroups requires large samples. Another
issue is that most clinical trials have not been mechanistic, due to a dearth of validated and robust biomarkers
for psychosis risk, and for other clinically important outcomes, such as mood and substance disorders, suicidal
ideation and behavior, persistent motivational/hedonic deficits and further functional decline. Prior investigations
have also not included standardized data protocols across studies. In response to these challenges, in 2020, the
NIMH launched the Accelerated Medicines Partnership® Schizophrenia (AMP® SCZ) project, a large,
observational study designed to de-risk the drug development process through validation of drug development
tools, including biomarkers related to cognition, brain structure and function, fluid biomarkers, genetic
vulnerability and communication. Investigators in the current proposal led the Data Processing, Analysis and
Coordination Center (DPACC) for the AMP SCZ project to manage and coordinate data from the clinical
networks, overseeing all aspects of data flow, quality assurance, processing, and analysis. The current proposal
is in response to RFA-MH-24-151, the next phase of the AMP SCZ project, to perform Proof of Principle (PoP)
clinical trials utilizing Phase 2 ready compounds to target pathophysiologically relevant mechanisms that have
the potential to produce a detectable signal (change) in biological, digital, cognitive, or clinical outcome measures
within a 12-16 week period of study. We propose the Clinical Trial DPACC (CT-DPACC) to provide executive
management, direction, and overall coordination, including data processing and analyses of data for the PoP
trial(s). We will maintain the current research team and organizational structure and augment it with a strong
regulatory team, including a contract research organization, to support investigational new drug submission(s)
and perform regulatory and safety monitoring. Our specific goals are (1) offer study design and regulatory
support, (2) manage, direct, monitor, and coordinate the multi-site clinical trials, and (3) develop data operation
procedures, biostatistics, and data analysis. Successful completion of the CT-DPACC project, in conjunction with
the supported PoP clinical trials netwo...

## Key facts

- **NIH application ID:** 10951184
- **Project number:** 1U24MH137171-01
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Sylvain Bouix
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $5,958,622
- **Award type:** 1
- **Project period:** 2024-06-17 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10951184

## Citation

> US National Institutes of Health, RePORTER application 10951184, Clinical Trial Data Processing, Analysis, and Coordination Center (CT-DPACC) for Accelerating Medicines Partnership Schizophrenia (AMP SCZ) Project (1U24MH137171-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10951184. Licensed CC0.

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