“My child hasn’t shown improvement since starting this medication overa month ago! Can we still expect itto work?” We’ve all been asked this difficult question, often by desperate parents—especially those of children taking antipsychotics. Now a recent study provides initial data to answer it.
To determine if early nonresponseto second generation antipsychoticswas predictive of “ultimate,” or long- term, non-response, data were collected from the SATIETY (Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth) cohort study. Subjects were selectedby chart review, and those includedin the analysis were ages four to 19and prescribed antipsychotics forthe diagnoses of psychotic spectrum disorder. Naturalistic treatment was pursued, with the outpatient clinician choosing a medication course as clinically indicated in these primarily antipsychotic- naïve subjects (77.2%).
Assessment was conducted withthe Children’s Global AssessmentScale (CGAS) and the Clinical Global Impression-Severity (CGI-S) at baseline, with the CGI-Improvement (CGI-I) added monthly in follow-up. Subjects were additionally monitored for side effects, particularly EPS, akathisia, and weight change. Treatment adherence was confirmed by monthly antipsychotic blood and plasma levels.
Seventy-nine children were included in the final analysis. Of note, Early Response (ER) was defined as scores of ≤3 (at least minimally improved), and Early Nonresponse (ENR) as ≥4 (worse or no change) on the CGI-I at four weeks. Ultimate Response (UR) (ie, long- term response) was defined by a score of 1 or 2 (much or very much improved), and Ultimate Nonresponse (ie, long- term nonresponse) was ≥3 (minimally improved or worse) on the GCI-I at eight to 12 weeks.
At week four, 36 subjects (45.6%) were early responders and 43 (54.4%) were early nonresponders. At week 12, 45 subjects (57%) were ultimate responders (UR) and 34 (43%) were ultimate non-responders (UNR).
The primary outcome of the study— the predictive value of early response or early nonresponse for ultimate response or ultimate nonresponse—had a negative predictive value of 67.4% and a positive predictive value of 86.1%. In other words, early response subjects showed greater long-term improvements in clinical ratings by the CGI-I and CGAS than the early nonresponse subjects.
Study authors report these findings with cautious optimism due to concern for small sample size and lack of controlled settings. However, given the approximation to adult and other first- break findings and the use of clinical scales, the clinical predictive value and ease of generalizability of this study positively add to the available literature in this area (Stentebjerg-Olesen M et al, J Child Adolesc Psychopharmacology 2013;23:1–11).
CCPR’s Take: The clinical usefulnessof this data is promising; however itwill require further investigation and replication with increased controls for further improvement of the knowledge base. It should be reiterated that this was a small study using a chart review of SATIETY participants and that the SATIETY study was not designed to look at this data in particular.
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