TY - JOUR
T1 - Suicide risk management for the sequenced treatment alternatives to relieve depression study
T2 - Applied NIMH guidelines
AU - Nierenberg, Andrew A.
AU - Trivedi, Madhukar H.
AU - Ritz, Louise
AU - Burroughs, Diane
AU - Greist, John
AU - Sackeim, Harold
AU - Kornstein, Susan
AU - Schwartz, Terry
AU - Stegman, Diane
AU - Fava, Maurizio
AU - Wisniewski, Stephen R.
N1 - Funding Information:
This project has been funded in whole or in part with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
PY - 2004
Y1 - 2004
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jpsychires.2004.03.004
DO - 10.1016/j.jpsychires.2004.03.004
M3 - Article
C2 - 15458854
AN - SCOPUS:5344270538
SN - 0022-3956
VL - 38
SP - 583
EP - 589
JO - Journal of Psychiatric Research
JF - Journal of Psychiatric Research
IS - 6
ER -