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Incorporating digital health technology tools in study design to assess medication adherence in schizophrenia trials

  • In central nervous system-focused clinical trials, having an appropriate study design can be helpful to mitigate known poor medication adherence, particularly in schizophrenia.
  • Previous reports have indicated that digital monitoring technology tools can improve adherence measured by detectable plasma level of study drug as part of the pharmacokinetics (PK) measure.
  • A smartphone-based app (the Platform) that uses video analysis technology to monitor study medication intake was employed in a clinical study evaluating investigational TAK-831/NBI-844 (luvadaxistat) as an adjunctive treatment for the negative symptoms of schizophrenia (the INTERACT study, NCT03382639).
  • We investigated the impact of including the Platform in the single-blind lead-in (SBLI) period of INTERACT as an inclusion criterion for the double-blind (DB) (post-randomization) period of the study.
  • We also investigated how adherence to Platform use correlated with pill count and detectable plasma luvadaxistat levels in participants randomized to luvadaxistat in the DB period.