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Two-year study of relapse prevention by a new education program in schizophrenic patients treated with the same antipsychotic drug

Published online by Cambridge University Press:  16 April 2020

Jean-Paul Chabannes
Affiliation:
Saint Egreve Hospital, Grenoble, France
Nadine Bazin
Affiliation:
Department of Psychiatry, Mignot Hospital, Versailles, France
Denis Leguay
Affiliation:
Cesame Hospital, Angers, France
Philippe Nuss
Affiliation:
Department of Psychiatry, Hospital Center of Saint Antoine, AP-HP, Université Paris VI, Paris, France
Charles-Siegfried Peretti
Affiliation:
Department of Psychiatry, Hospital Center of Saint Antoine, AP-HP, Université Paris VI, Paris, France
Patrick Tatu
Affiliation:
Department of Psychiatry, Centre Hospital Centre of Saint Etienne, Saint Etienne, France
Ahcene Hameg
Affiliation:
Psychiatric Department, Sanofi-Aventis, Paris, France
Ricardo P. Garay*
Affiliation:
EA2381, Université Paris VII, Paris, France
Maurice Ferreri
Affiliation:
Department of Psychiatry, Hospital Center of Saint Antoine, AP-HP, Université Paris VI, Paris, France
*
*Corresponding author. 46bis, rue du Maréchal Galliéni, 91360 Villemoisson-sur-Orge, France. E-mail address: ricardo.garay@orange.fr (R.P. Garay).
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Abstract

It is not clear whether patient's psycho-education enhances compliance to antipsychotic treatments and reduces the number of relapses. Here we investigated the impact of a new psycho-educational program (SOLEDUC®) on the one- and two-years rate of relapse (primary outcome measure) and a number of clinical assessments (secondary outcome measures). This was a multicentric French clinical trial (51 centers) of Phase IV, open, controlled, randomized, consisting in two parallel groups: the Soleduc group (N = 111) and the control group (N = 109). All subjects received a variable dose over the 2-year period of the same antipsychotic drug (amisulpride). Soleduc consisted of a 7-session program (1 h per session), presented three times (at baseline, 6-months and 12-months). Patients in the control group received a non-specific psychosocial training for an equivalent period of time. The models of Andersen-Gill (AG) and Prentice, Williams and Peterson (PWP) were used to analyze relapses. Patients in the Soleduc group attended 14.8 ± 6.1 sessions (mean ± SD), including 17 patients who never attended a session. Intent to treat analysis showed less patients relapsing in the Soleduc group as compared to the control group (21.6% versus 28.4% after 1 year and 84.4% versus 90.8% after 2 years), but the differences were not statistically significant. Relapse risk was significantly reduced for patients who followed at least 7 modules (p = 0.015 AG-test; p < 0.001 PWP-test). In conclusion, no significant differences in relapse rates were found between patients attending the Soleduc program and the control group. Attendance of at least 7 out of 21 program sessions was required to see a modest, but significant two-year relapse prevention in schizophrenia. Other well designed studies are required to evaluate the medical impact of patient's education programs.

Type
Original articles
Copyright
Copyright © Elsevier Masson SAS 2008

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