Coming Soon – New ISCTM Working Group

Medication (and Brain Stimulating Device) Assisted Psychotherapy Clinical Trials Working Group

Chairs: Walter Dunn, MD, PhD; Zimri Yaseen, MD

The aim of this working group is to develop a better understanding of the scientific and regulatory issues affecting clinical trial design for treatments meant to rely on the combination of medication with psychotherapy, with the aim of developing guidance for appropriate trial design to support development and approval of medications intended to be used in combination with or as enhancers of psychotherapies.

These issues include:
· potentially treatment-intrinsic functional unblinding (e.g., psychedelics)
· distinctive endpoints such as intra-therapeutic process outcomes (e.g., extinction learning, working alliance formation)
· characterization of psychotherapy component of treatment
· accounting for psychotherapist effects
· accounting for psychotherapy effects
· distinctive needs in, limits on, and characteristics of regulation of medication-psychotherapy combinations

Inaugural Meeting: 16th Annual Scientific Meeting Working Group Session, 19-21 February, Washington DC

Contact the secretariat with your interest: isctm@isctm.org