Suicide risk management for the sequenced treatment alternatives to relieve depression study: Applied NIMH guidelines

Andrew A. Nierenberg, Madhukar H. Trivedi, Louise Ritz, Diane Burroughs, John Greist, Harold Sackeim, Susan Kornstein, Terry Schwartz, Diane Stegman, Maurizio Fava, Stephen R. Wisniewski

Research output: Contribution to journalArticlepeer-review

22 Scopus citations


NIMH guidelines to manage subjects who are suicidal during their participation in clinical trials include a full range of procedures to minimize suicidal risk, yet no reports to date have shown how researchers should best implement these guidelines. The architects of the sequenced treatment alternatives to relieve depression (STAR*D) study operationalized and implemented the NIMH guidelines by developing a comprehensive set of procedures to detect, monitor, and manage suicidal subjects during a large, complex, multisite clinical trial. Because of the large size of the study (anticipated n=4000), the wide geographic distribution, the large number of treating STAR*D clinicians, the broad array of subjects with psychiatric and medical comorbidities, and the focus on treatment-resistant depression, along with the complexity of multiple treatment steps and randomization points in STAR*D, the risk of suicide, safety monitoring of suicidal subjects presented a unique challenge. This paper describes methods derived from the NIMH guidelines used to manage suicidal risk in STAR*D including the use of an interactive voice response system to alert clinicians, regional center directors, and safety officers.

Original languageEnglish (US)
Pages (from-to)583-589
Number of pages7
JournalJournal of Psychiatric Research
Issue number6
StatePublished - 2004

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry


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