Safety Assessments
dissociative symptoms, auditory and visual disturbances, Dissociative, psychotic symptoms, heaviness
ADVERSE EVENT, ADVERSE EVENT
Adverse events were monitored throughout the study. Dissociative and positive psychotic symptoms, respectively, were assessed pre-dose and 40 and 90 minutes post-dose using the CADSS (Adverse events were also assessed based on investigator report. The SUSTAIN-2 protocol specified that any untoward medical occurrence that was new in onset or increased in severity following treatment initiation should be reported as a treatment-emergent adverse event. The protocol did not provide investigators with specific guidance of what symptoms constitute an adverse event of dissociation or how/when dissociation as an adverse event should be reported.Dissociation is a unique preferred term in the Medical Dictionary for Regulatory Activities dictionary, and most site investigators reported “dissociation, dissociative symptoms” as adverse event terms that are coded to the preferred term “dissociation.” However, site investigators also reported other terms to describe dissociative symptoms that have been coded to “dissociation” per instruction from the Food and Drug Administration, such as symptoms of auditory and visual disturbances, illusion, feeling abnormal (feeling of floating, flying, falling, detached, heaviness, lightness, etc.), and dreamy state. While potentially allowing for the possibility of increased between-site variability, this approach could be argued to provide a more generalizable picture of what may be happening across a variety of treatment settings, wherein one would not expect the level of standardization of adverse event reporting obtained by using structured psychometric instruments.