Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Page 98 of 201

[ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] Innovations in CLINICAL NEUROSCIENCE 99 can be disaggregated from any anti- depressant effects (as measured by the MADRS). According to Khan et al, 21 "The reduction of S-STS scores w as large (43%) and twice that seen in MADRS scores (25%) among the 80 patients in the trial. Both response (c 2 =8.8, p<0.01) and remission rates (c 2 =4.6, p=0.03) showed similar patterns." Comparison of S-STS to C-SSRS. The S-STS differs from the C–SSRS in several respects. First, the C–SSRS uses a hierarchical Guttman-like scale structure for suicidal ideation items and combinations. As Mundt et al 12 observe, the presence of suicidal ideation on the C–SSRS is ascertained at five levels of increasing degrees of ideation severities. These include passive ideation and four levels of active ideation (thoughts of killing self, thoughts of method for killing self, intentions to kill self, and development of plans for committing suicide). The last three levels of ideation are only evaluated on the C–SSRS if thoughts of killing oneself are first endorsed. 12 Effectively this means that if the patient does not have non-specific, active suicidal ideation, the rater cannot inquire about method, plan, or intent. This is not the case with the S-STS. The S- STS does not assume nor make use of a Guttman scaling procedure or assumptions in evaluating suicidal ideation and or behaviors. Second, the C–SSRS uses a yes/no response format for the suicidal ideation items, whereas the S-STS allows finer tuned ratings on an ordered scale from 0 to 4. While the C–SSRS does provide for an intensity rating, it is categorical (not ordered) and only applies to the most severe category endorsed, based on its 1 to 5 hierarchical categorization. This means that other categories, even though they may be experienced as more severe, are not rated for intensity because they are ranked lower on this a priori hierarchy. Third, the C–SSRS is generally clinician-rated, whereas the S-STS can be patient-rated or clinician-rated. TRAINING, CURRENT USE, AND APPLICATIONS Training. The FDA requires training before suicidality instruments are used in clinical trials. Sponsors, rater training agencies, and clinical research organizations can handle the training on the S-STS as long as they adhere to the FDA's expectations on the FDA-CASA 2012 definitions. Training is not required for licensed practitioners using the S-STS in clinical practice. Current use. The most current data on usage of the S-STS in clinical trials comes from the 2013 International Society for CNS Clinical Trials and Methodology (ISCTM) survey. This survey assessed use of different suicidality instruments by 1,447 industry employees at 178 companies large and small. In a study examining these survey results, Chappell et al 23 received back 129 responses from 50 companies, but analyzed only the data on the subset of 86 respondents who indicated direct involvement with suicidal ideation and behavior. Results of the survey indicated that the C–SSRS was used for tracking suicidality by 94 percent of the participants, the S-STS by 22.4 percent, and the ISST-Plus by 10.4 percent. Some respondents noted that they had used more than one instrument. In addition, the S-STS is currently being used in a national initiative assessing suicidality in South African Veterans mandated by the Parliament of South Africa. 24 The National Institute of Mental Health and Neuro Sciences (NIMHANS) in India is using an adapted version in its 2014 India national mental health epidemiology study. 25,26 It is difficult to get a precise estimate on the number of studies that have used the S-STS. The first author of this article (D.S.) has given permission for its use in many studies, including those investigating biomarkers and genetic linkage, where the S-STS disaggregated suicidal phenomena may provide the fine- grained phenotyping needed in such studies. Applications. Careful suicidality assessment and tracking are needed and indeed increasingly mandated and have become routine in psychiatric research, mental health, and medical as well as other settings. 2 Clinical trials. In clinical trials, the S-STS is a potentially powerful tool to detect anti-suicidal signals from new medications. 13,21,22 It also offers a valuable alternative to the C–SSRS for assessing suicidal ideation and behavior FIGURE 5. Use of the S-STS in detecting an efficacy signal with lithium Data adapted from Khan et al (2011) 21 S-STS: Sheehan-Suicidality Tracking Scale; MADRS: Montgomery Asberg Depression Rating Scale

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