SMARTer discontinuation trial designs for developing an adaptive treatment strategy

Daniel Almirall*, Scott N. Compton, Moira A. Rynn, John T. Walkup, Susan A. Murphy

*Corresponding author for this work

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objective: Developing evidenced-based practices for the management of childhood psychiatric disorders requires research studies that address how to treat children during both the acute phase of the disorder and beyond. Given the selection of a medication for acute treatment, discontinuation trials are used to evaluate the effects of treatment duration (e.g., time on medication) and/or maintenance strategies following successful acute-phase treatment. Recently, sequential multiple assignment randomized trials (SMART) have been proposed for use in informing sequences of critical clinical decisions such as those mentioned. The objective of this article is to illustrate how a SMART study is related to the standard discontinuation trial design, while addressing additional clinically important questions with similar trial resources. Method: The recently completed Child/Adolescent Anxiety Multimodal Study (CAMS), a randomized trial that examined the relative efficacy of three acute-phase treatments for pediatric anxiety disorders, along with a next logical step, a standard discontinuation trial design, is used to clarify the ideas. This example is used to compare the discontinuation trial design relative to the SMART design. Results: We find that the standard discontinuation trial can be modified slightly using a SMART design to yield high-quality data that can be used to address a wider variety of questions in addition to the impact of treatment duration. We discuss how this innovative trial design is ultimately more efficient and less costly than the standard discontinuation trial, and may result in more representative comparisons between treatments. Conclusions: Mental health researchers who are interested in addressing questions concerning the effects of continued treatment (for different durations) following successful acute-phase treatment should consider SMART designs in place of discontinuation trial designs in their research. SMART designs can be used to address these and other questions concerning individualized sequences of treatment, such as the choice of a rescue treatment in case of postacute phase relapse.

Original languageEnglish (US)
Pages (from-to)364-374
Number of pages11
JournalJournal of Child and Adolescent Psychopharmacology
Volume22
Issue number5
DOIs
StatePublished - Oct 1 2012

Fingerprint

Therapeutics
Practice Management
Anxiety Disorders
Research
Psychiatry
Mental Health
Anxiety
Maintenance
Research Personnel
Pediatrics
Recurrence
Data Accuracy

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Almirall, Daniel ; Compton, Scott N. ; Rynn, Moira A. ; Walkup, John T. ; Murphy, Susan A. / SMARTer discontinuation trial designs for developing an adaptive treatment strategy. In: Journal of Child and Adolescent Psychopharmacology. 2012 ; Vol. 22, No. 5. pp. 364-374.
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SMARTer discontinuation trial designs for developing an adaptive treatment strategy. / Almirall, Daniel; Compton, Scott N.; Rynn, Moira A.; Walkup, John T.; Murphy, Susan A.

In: Journal of Child and Adolescent Psychopharmacology, Vol. 22, No. 5, 01.10.2012, p. 364-374.

Research output: Contribution to journalArticle

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