Autumn 2025 Working Group Session Descriptions

Sessions will take place at the Amsterdam Marriott Hotel, between the adjournment of the final ISCTM Autumn Conference General Session (12:55) and the start of the ECNP Congress
Saturday 11 October
13:00-13:45 Lite lunch for Working Group participants (take to session rooms)
13:20-14:50 Working Group Sessions
Rooms TBD

Attendees may select one working group during registration.

Accelerating Development of Psychopathology Measures – Joint ISCTM/ECNP Working Group (Schooler, Arango, Engler)

The ISCTM/ECNP Joint Working Group (WG) on Accelerating Development of Psychopathology Measures was initiated at the Autumn 2023 conference in Barcelona following the session “Are our clinician rated psychopathology measures fit for purpose decades later?” that focused on the widely used scales for clinical trials in schizophrenia, depression and bipolar disorder. At that inaugural session WG discussion addressed aspirations, goals, and targets for initial work products. Since then, the WG has been working in three subgroups charged with addressing the Clinical Outcome Assessment (COA) rating scales for bipolar disorder, depression and schizophrenia. The subgroups have continued to meet both virtually and in person in conjunction with ISCTM meetings. The bipolar group is developing a manuscript that addresses the strengths and challenges in use of the Young Mania Rating Scale and is seeking access to data sets to evaluate its performance over time. The schizophrenia group has a completed manuscript titled “The PANSS (1987): Is it Fit for Purpose” that is in review by authors for submission. It is also developing a protocol for focus groups with persons with lived experience and supporters to provide their perspective on clinical outcomes that matter to them. This is seen as a first step in developing an improved COA for this population. The depression group is developing a manuscript that evaluates the current COAs in use, the MADRS and HAM-D. It is also considering the possibility of updating the SIGH-D with author Janet B. Williams.

The Accelerate WG meeting in conjunction with the 2025 ISCTM ECNP meeting will provide the opportunity for broader input from the ECNP community. The full group with meet to discuss broad issues that are relevant to developing COAs that meet modern regulatory agency standards, incorporation of new outcomes and novel assessment strategies such as ecological momentary assessment and computerized adaptive testing. We will also have updates from each of the subgroups after which the subgroups will convene to continue their work. Please indicate which subgroup you would like to join when choosing to attend the Accelerate WG.

Defining and Standardizing Vocal Biomarker Outcomes Working Group (Cohen, Sedway)

This working group plans to address this problem statement:
To establish vocal biomarkers as recognized endpoints by regulatory bodies, it is essential to develop consistent, accurate, and precise measurement procedures. Standardization in this field will pave the way for broader acceptance and application in clinical research.

Speech latencies are particularly promising for use in clinical trials. Speech latency involves the pause time before an individual speaks, for example, when responding to an interviewer. They are typically measured as a reaction time in milliseconds, are tied to important socio-cognitive functions that potentially matter to patients and their caregivers, and have been tied to various aspects of psychopathology through correlational and experimental methods. Speech latencies are simple and transparent to compute and interpret, and can potentially be used across diverse populations, languages and cultures. For vocal biomarkers to gain acceptance from regulatory authorities and to ensure trust from stakeholders, it is crucial to precisely define and standardize their measurement.

Working Group Objectives:
A working group will be established to address the following:
1) Discuss the various methods of collecting speech latency, analyze the evidence for each approach, come to a consensus on approach recommended for FDA COA Qualification program
2) Write a manuscript detailing the above process and decisions
3) Determine and document the additional steps needed for FDA COA Qualification for Speech Latency

Orphan Diseases Working Group (Busner, Pandina)

The Orphan Diseases Working Group will meet in Amsterdam at the joint ISCTM/ECNP meeting! We will review ongoing manuscripts, generate ideas for new manuscripts, share experiences, and discuss further collaborations. Core members and new members welcome!

Sleep Methodology in CNS Trials Working Group (Moline, Dorffner)

This working group aims at contributing to a better understanding of the use of sleep-related measurement methodology in CNS trials, as well as promoting their use. Since its initiation in 2024 the WG has made progress toward two deliverables:
• A review paper on sleep and vigilance-related endpoints that have been proven to be potential biomarkers for predicting or monitoring different psychiatric and neurological disorders. At the latest meeting the decision was to split the exercise by disorder, each covered by one or two volunteers.
• A consensus paper on validation methods for novel instruments (such as portable EEG devices, photo-plethysmography, actigraphy, etc.) deriving such trial endpoints. Here the proposal is to define a rigorous framework of statistical equivalence testing exploiting the well-known inter-rater variability of the gold standard as a basis for setting tolerance intervals. Also, a call for references and potential further statistical frameworks was issued.
This session will be mainly devoted to finalizing the first deliverable after presenting a first draft merging all individual contributions. Furthermore, the methodology for statistical equivalence testing as a cornerstone for the second deliverable will be discussed and refined.