Accelerating Development of Psychopathology Measures – Joint ISCTM/ECNP Working Group
Chairs: Nina R. Schooler, PhD; Celso Arango, MD, PhD; Jenicka Engler, PsyD
Upcoming Activity: Working Group Meeting, 2025 Autumn Conference includes joint day with ECNP, 9-11 October 2025, Amsterdam, The Netherlands
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.
Most Recent Activity: Working Group Meeting, 2024 Autumn Conference, 12-13 September 2024, San Diego, CA – View slides, view summary
Working Group Meeting, 20th Annual Scientific Meeting, 21-23 February 2024, Washington DC – View slides, view summary
INAUGURAL MEETING: 2023 Autumn Conference – includes joint day with ECNP, view slides, 5-7 October 2023, Barcelona, Spain
The ISCTM and ECNP are partnering in a joint Working Group on Accelerating Scale Development to examine strategies that can speed development of clinical outcome assessments (COAs) and measures of psychopathology for use in clinical trials. This new WG will take place immediately following the ISCTM session on Saturday, October 7th titled Are our clinical psychopathology rating scales fit for purpose decades later? prior to the start of the ECNP Congress to build upon the session.
Although they may have served us well in the past, current COAs developed decades ago for the drugs in development at that time do not address the full range of signs and symptoms that characterize the complex disorders we treat. New medications with novel mechanisms of action may address psychopathological domains that have not been treatable by prior agents, or not measured on established COAs. As part of this effort, the WG will empirically examine whether current COAs used in CNS drug development are “fit for purpose” to detect change and differentiate between drug-placebo in trials by comparing data from historical and recent development programs with newer drug MOAs.