Two-year study of relapse prevention by a new education program in schizophrenic patients treated with the same antipsychotic drug.
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 (1h 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 2years), 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.
Chabannes
Jean-Paul
JP
Saint Egreve Hospital, Grenoble, France.
Bazin
Nadine
N
Leguay
Denis
D
Nuss
Philippe
P
Peretti
Charles-Siegfried
CS
Tatu
Patrick
P
Hameg
Ahcene
A
Garay
Ricardo P
RP
Ferreri
Maurice
M
D000328:Adult; D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D017327:Clinical Trials, Phase IV as Topic / Q000706:statistics & numerical data; D035061:Control Groups; D005260:Female; D006801:Humans; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D011379:Prognosis; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011613:Psychotherapy / Q000379:methods; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy* / Q000517:prevention & control*; D012565:Schizophrenic Psychology; D055502:Secondary Prevention; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D013469:Sulpiride; D000077582:Amisulpride