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 – Core Subgroup Teams, 2026 Autumn Conference, 16-17 September 2026, Philadelphia, PA
Bipolar Subgroup: Accelerating Development of Psychopathology Measures – Joint ISCTM/ECNP Working Group (Singh, Vieta)
The Bipolar subgroup recently submitted a manuscript on the merits of the YMRS in its context of use as primary outcome assessment for acute mania and mixed episode trials in Bipolar Disorder. With increasing appreciation that there remain unmet needs for patients beyond the acute phase, we will focus our attention next on the development of other scales and endpoints, including for studies in bipolar depression, mixed features, co-occurring conditions, as well as to support the development of longer-term maintenance interventions.
MDD Subgroup: Accelerating Development of Psychopathology Measures – Joint ISCTM/ECNP Working Group (Engler, Sommer)
The MDD subgroup will review progress on the manuscript evaluation of the MADRS in its context of use as primary outcome assessment for Major Depressive Disorder (MDD) research studies as well as the data and analysis forthcoming to examine antidepressant efficacy and differentiation in trials over time.
Schizophrenia Subgroup: Accelerating Development of Psychopathology Measures – Joint ISCTM/ECNP Working Group (Khan, Mucci, Desjardins)
The schizophrenia subgroup has completed a manuscript reviewing the strengths and limitations of the PANSS, the current gold standard for clinician-assessed psychopathology in schizophrenia and non-affective psychosis. Given that multiple groups are actively working to improve existing methods and develop next generation rating scales, this subgroup will now shift its focus to developing a framework for an improved measure that can support and complement these efforts.
Key questions to be considered include: How should stakeholder concerns be addressed? What should the structure of a new interview format look like? Should the interview guide be integrated within the scale or developed as a standalone tool? What is the most appropriate gold standard for psychometric validation? How can feasibility of administration (e.g. rater training, supervision, patient burden) be optimized?
The goal is to define core principles that will ensure any new measure is both scientifically rigorous and practical for real-world clinical and research settings.
Most Recent Activity: Working Group Meeting – Core Subgroup Teams, 22nd Annual Scientific Meeting, 18-20 February 2026, Washington DC – Bipolar Subgroup Summary, MDD Subgroup Summary
The ISCTM/ECNP joint working group Accelerating Development of Psychopathology Outcome Measures met on October 11, 2025 at the Joint Meeting of our two organizations. At that meeting we had updates on activities by the three subgroups that are focused on Schizophrenia, Bipolar Disorder and Depression. Attendees also had the opportunity to complete a survey regarding needs for clinician rated symptoms measures for the three patient groups. The survey has also been distributed to others through a variety of routes. These data represent the input of researchers and clinicians, an important stakeholder group whose perspective is needed in development of suitable measures. At the ISCTM Annual meeting, the subgroups will meet separately. The groups will review the results of the survey and other work that has been accomplished since the October meeting.
Working Group Meeting, 2025 Autumn Conference includes joint day with ECNP, 9-11 October 2025, Amsterdam, The Netherlands
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.