Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials

Charles L. Bowden, Vivek Singh

Research output: Chapter in Book/Report/Conference proceedingChapter


In addition to an initial randomization, Sequential Multiple Assignment Randomized Treatment (SMART) methodologies allow the sequential introduction of a second randomized intervention based on a patient's state and response during the trial. SMART designs resemble the adaptive nature of treatment selection that occurs in clinical settings. The advantages of SMART include yielding more inclusive enrollment, thereby enhancing generalizability of results. With single front end randomization, if any of the treatment options are unacceptable, the patient is excluded from the study or will choose not to enter. SMART studies focus on effectiveness both by emphasizing sustained benefit and efficacy in conjunction with tolerability, in contrast to outcomes based on single point in time assessment. The controlled design allows causal inference and eliminates unmeasured confounders associated with nonrandomized treatment decisions.

Original languageEnglish (US)
Title of host publicationClinical Trial Design Challenges in Mood Disorders
PublisherElsevier Inc.
Number of pages12
ISBN (Print)9780124051768, 9780124051706
StatePublished - Jan 22 2015


  • Bipolar
  • Clinical trials
  • Effectiveness
  • Generalizability
  • Methodologies
  • Randomized

ASJC Scopus subject areas

  • Psychology(all)


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