Studio multicentrico in aperto sull’efficacia differenziale a medio termine, del trattamento con Aloperidolo, Clozapina, Olanzapina e Risperidone in pazienti schizofrenici

Introduction: There has been considerable support for the observation that atypical antipsychotics have a broader range of therapeutic effects than traditional antipsychotics. Specifically, they appear to be superior in terms of improvement of negative, cognitive, and affective symptoms in patients with schizophrenia. The purpose of this study was to compare the long-term efficacy of SGAs (Clozapine, Olanzapine, Risperidone) and FGAs (Haloperidol) on the different symptoms of schizophrenia. The analysis had 2 principal objectives: 1. to assess whether a significant change over time occurred in any of the 4 treatment groups; 2. to test whether there is a slope difference between the 4 medication groups in syndrome change trajectories over time. Materials and method: A multicentric open-study has been carried out in Italy, in seven University centres (Catanzaro, Chieti, Florence, L'Aquila, Pescara, Rome and Trieste). The study population comprised 126 patients with DSM-IV schizophrenia disorder diagnosis, 81 males (64.3%) and 45 females (35.7%), mean age 34.2 ± 10.1 years (range 18-64) (Tabs. I-II). Patients were assigned to treatment with Clozapine, Olanzapine, Risperidone, or Haloperidol, according to the judgment of a senior Psychiatric Specialist (Tab. III). The efficacy evaluation was assessed by means of Positive and Negative Syndrome Scales (PANSS), 3-THREE, CGI and Hamilton Rating Scales for Depression (HAM-D). The subjects were evaluated at first visit (T0), after 30 days (T30), 60 days (T60), 90 days (T90) and 120 days (T120). The measures of efficacy were analysed with a repeated measures analysis variance (MANOVA), with the technique of the contrast group of treatment, including the basal score in the model. Results: The efficacy analysis showed a statistically significant difference in the PANSS total (Tab. IV), Positive (Tab. V) and General subscale (Tab. VI) scores in all assessments of the four groups. PANSS Negative subscale score (Tab. VII) differences were statistically significant for Clozapine, Risperidone and Olanzapine, but not for Haloperidol. The intergroup analysis showed that the Negative subscale improvement, at 120 days, was greater in the Clozapine, Risperidone and Olanzapine groups than in the Haloperidol group. The HAM-D total scores efficacy analysis (Tab. VIII) indicated that the symptoms improved in all assessments in the four groups. The improvement in the SGAs groups at 90 and 120 days' evaluations was significantly greater than in the Haluperidol group. The 3-THREE analysis showed a significant improvement in T60, T90 and T120 total scores and Positive subscale in all four groups. The improvement of Negative and Behavioural 3-THREE subscale was statistically significant for SGAs, but not for Haloperidol. The Negative symptoms improvement after 120 days' treatment, assessed by the Negative and Behavioural 3-THREE subscale was greater in the SGAs groups than in the Haloperidol group and the improvement after 30 days' treatment was greater for Clozapine than for all the other three groups (Fig. 1). The seventy CGJ scores at T30 assessment was lower for Olanzapine and Risperidone than for Clozapine and Haloperidol. Conclusion: In conclusion, our data confirm that all 3 SGAs were associated with significant improvements in the positive, negative and affective symptoms of schizophrenia. In contrast, Haloperidol had only a marginally significant effect on the positive domain while the effect on the negative domain worsened.