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

Andrew A Nierenberg1, Madhukar H Trivedi, Louise Ritz

  • 1Clinical Research Program, Clinical Psychopharmacology Unit, Massachusetts General Hospital, ACC 812, 15 Parkman Street, Boston, MA 01224, USA. anierenberg@partners.org

Journal of Psychiatric Research
|October 2, 2004
PubMed

Insights

Managing suicidal risk in clinical trials is crucial. This study details methods used in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial to implement National Institute of Mental Health (NIMH) guidelines for subject safety.

Area of Science:

  • Clinical Psychology
  • Psychiatric Research
  • Clinical Trial Management

Background:

  • National Institute of Mental Health (NIMH) guidelines exist for managing suicidal subjects in clinical trials.
  • Implementation strategies for these guidelines in large-scale, complex trials remain underexplored.

Purpose of the Study:

  • To describe the operationalization and implementation of NIMH suicide risk management guidelines within the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study.
  • To present methods for detecting, monitoring, and managing suicidal subjects in a large, multisite clinical trial setting.

Main Methods:

  • Development of a comprehensive set of procedures based on NIMH guidelines.
  • Utilization of an interactive voice response (IVR) system for timely alerts to clinicians, directors, and safety officers.
  • Adaptation of safety monitoring protocols for a complex trial with treatment-resistant depression, comorbidities, and multiple randomization points.

Main Results:

  • The STAR*D study successfully operationalized NIMH guidelines for managing suicidal risk.
  • The implemented procedures provided a framework for monitoring and managing suicidal subjects across a large, geographically distributed trial.
  • The IVR system facilitated rapid communication and intervention for at-risk individuals.

Conclusions:

  • Effective implementation of suicide risk management guidelines in large clinical trials is feasible with structured protocols.
  • A systematic approach, including technological aids like IVR systems, is vital for ensuring subject safety in complex psychiatric research.
  • The STAR*D experience offers a model for managing suicidal ideation and behavior in clinical trial participants.

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