ARTICLESEffectiveness of the Information Technology-Aided Program of Relapse Prevention in Schizophrenia (ITAREPS) A Randomized, Controlled, Double-Blind StudyŠPANIEL, FILIP MD*; HRDLIČKA, JAN MA†; NOVÁK, TOMÁŠ MD*; KOŽENÝ, JIŘÍ PsyD*; HÖSCHL, CYRIL MD*; MOHR, PAVEL MD*; MOTLOVÁ, LUCIE BANKOVSKÁ MD* Author Information *Prague Psychiatric Center, 3rd Faculty of Medicine, Charles University, Center of Neuro psychiatric Studies, Prague, Czech Republic †Czech Technical University, Faculty of Electrical Engineering, Department of Cybernetics, Prague. Filip Španiel MD, Tomáš Novák MD, Jiří Kožený, PsyD, Cyril Höschl, MD, Pavel Mohr, MD, and Lucie Bankovská Motlová, MD, received honoraria from Eli Lilly Co. Jan Hrdlička, MA, declares no conflicts of interest. Acknowledgement: This was an investigator-initiated trial funded by Eli Lilly Company. Eli Lilly had no further role in the collection, analysis, and interpretation of data. ITAREPS was developed by the Prague Psychiatric Centre as an academic project, technically supported by Academia Medica Pragensis (Amepra). Amepra is an agent and ethical guarantor of relations between Eli Lilly Czech Republic which provided funds for ITAREPS development and the academic group involved in the project development and implementation. ITAREPS (http://www.itareps.com) is operated under the auspices of the Psychiatric Society CLS JEP of the Czech Republic and the Psychiatric Society SLS of the Slovak Republic. We greatly appreciate the consultation and invaluable help in study design of Drs. R. Brousil and P. Vohlídka. Please send correspondence to: Filip Španiel, MD, Prague Psychiatric Center, Ústavní 191, 181 03 Prague 8, Czech Republic. [email protected] Journal of Psychiatric Practice 18(4):p 269-280, July 2012. | DOI: 10.1097/01.pra.0000416017.45591.c1 Buy Metrics Abstract Purpose. To evaluate the effectiveness of the Information Technology-Aided Program of Re lapse Prevention in Schizophrenia (ITAREPS). Methods. Relapse-prone outpatients with schizophrenia or schizoaffective disorder were randomized to the active (n=75) or control group (n=71). In the active arm, according to the protocol, investigators were prompted to increase the antipsychotic dose upon occurrence of a pharmacological inter vention requiring event (PIRE) detected by ITAREPS. Results. Intention-to-treat (ITT) analysis found no between-group difference in the hospitalization-free survival rate at 12 months. However, the trial suffered from high non-adherence of investigators in the active group, with no antipsychotic dose increase in 61% of PIREs. Furthermore, Cox regression analysis showed a 11-fold increased risk of hospitalization in the absence of pharmacological intervention following a PIRE (hazard ratio [HR]=10.8; 95% confidence interval [CI] 1.4–80.0; p=0.002). Therefore, a post-hoc as-treated analysis was performed, which demonstrated a nine-fold reduction in the risk of hospitalization in ITAREPS Algorithm-Adherers (IAAs, n=25) compared with the ITAREPS Non-interventional group (INIs, n=70; Kaplan-Meier survival analysis, HR=0.11, 95% CI 0.05–0.28, p=0.009; number needed to treat [NNT]=4, 95% CI 3–10). A significant difference in favor of the IAA group was seen in the number of inpatient days (p<0.05) and costs (p<0.05). Conclusion. Future ITAREPS trials should target the underlying mechanisms that cause low investigator adherence to the program. Trial registration: Clinical Trials NCT00712660 (Journal of Psychiatric Practice 2012;18:269–280) Copyright © 2012 Wolters Kluwer Health, Inc. All rights reserved.