P126: Remote Psychometric Assessments are Comparable in Quality to In-Person Administration: Evidence from Two Depression Trials

Poster Presenter

Chris Reist

Medical Director, Psychiatry and Behavioral Science
Science 37
United States

Objectives

The quality of diagnostic assessment and depression symptom ratings in two BoehringerIngelheim-sponsored clinical Phase II trials was compared: one conducted as a fully decentralized (DCT), the other as a global traditional site-based (TRAD) trial.

Method

Both trials, with nearly identical designs, evaluated the efficacy of adjunctive treatment for MDD patients with insufficient response to antidepressant monotherapy. Diagnosis was established utilizing the Structured Clinical Interview for DSM-V (SCID). The primary outcome measure was the MADRS.

Results

DCT had 86 patients (44 randomized) and TRAD had 286 patients screened (146 randomized) at the time of data analysis. For the MADRS, Cronbach’s alpha (a) for baseline (V1) showed DCT a= 0.82 and TRAD a= 0.71. Subsequent visits showed steady increase for both: DCT a= 0.91 and TRAD a= 0.89 at V8. DCT had lower total MADRS mean scores and lower variation (SD) at each time point than TRAD. The need for interventions (clinical contacts) by Signant Health reviewers was 11%, placing it in the top half of all combined sites. For the SCID, the intervention rate was 12.5% for DCT compared to 21.2% for TRAD.

Conclusion

This is the first opportunity to report on quality of diagnostic (SCID) and depression symptom (MADRS) assessment conducted remotely in direct comparison to a parallel site based trial. DCT was above average in terms of administration and scoring suggesting comparable quality.