Symptomatic remission in schizophrenia patients treated with aripiprazole or haloperidol for up to 52 weeks.

BACKGROUND: The Remission in Schizophrenia Working Group (RSWG) has defined criteria for symptomatic remission based on achieving and maintaining a consistently low symptom threshold for at least six consecutive months. This analysis examined symptomatic remission in acutely ill patients with schizophrenia receiving either aripiprazole or haloperidol for one year. METHODS: Pooled data from two 52-week, randomized, double-blind, multicenter, comparative trials of aripiprazole and haloperidol in acutely ill patients with schizophrenia were analyzed. Measures of symptomatic remission were calculated according to RSWG criteria. RESULTS: Remission rates were significantly higher for patients treated with aripiprazole compared with haloperidol (32% vs 22%, respectively; p<0.001, LOCF). Among remitters, aripiprazole-treated patients achieved symptom criteria in a significantly shorter time than haloperidol-treated patients (log rank p=0.0024). For trial completers, remission rates were similarly high in both groups (aripiprazole, 77%; haloperidol, 74%). Regardless of treatment type, remitters received significantly higher global clinical ratings than nonremitters (p<0.0001). Aripiprazole was associated with a significantly lower rate of discontinuations due to adverse events (AEs) than haloperidol (8.0% vs 18.4%, respectively; p<0.001) as well as lower concomitant medication use for extrapyramidal symptoms (EPS) (23% vs 57%, respectively; p<0.001). CONCLUSION: Acutely ill schizophrenia patients treated with aripiprazole demonstrated a significantly higher rate of symptomatic remission across 52 weeks compared with haloperidol-treated patients. The similar remission rates among trial completers in both treatment groups, combined with fewer AE-related discontinuations and lower EPS medication use in the aripiprazole group, suggest that better tolerability with aripiprazole may have contributed to superior overall remission rates.

Risperidone and haloperidol in first-episode psychosis: a long-term randomized trial.

OBJECTIVE: The first episode of psychotic illness is a key intervention point. The initial experience with medication can affect willingness to accept treatment. Further, relapse prevention is a treatment cornerstone during the first years of illness because active psychotic illness may affect lifetime outcomes. Thus, initial treatment of active symptoms and subsequent relapse prevention are central goals of pharmacotherapy. This study compared long-term effectiveness of risperidone versus haloperidol in first-episode psychosis patients. METHOD: First-episode psychosis patients (N=555, mean age=25.4 years) participated in a double-blind, randomized, controlled flexible-dose trial that compared risperidone (mean modal dose=3.3 mg) and haloperidol (mean modal dose=2.9 mg). The median treatment length was 206 days (maximum=1,514). RESULTS: Positive and Negative Syndrome Scale scores and Clinical Global Impression ratings improved significantly relative to baseline, with no significant differences between groups. Three-quarters of the patients achieved initial clinical improvement, defined as >20% reduction in total Positive and Negative Syndrome Scale score. However, among those who achieved clinical improvement, 42% of the risperidone group experienced a relapse compared with 55% of the haloperidol group. The median time to relapse was 466 days for risperidone-treated subjects and 205 days for those given haloperidol. These differences were statistically significant based on Kaplan-Meier survival analysis. Adverse effects distinguished the treatments: there were significantly more extrapyramidal signs and symptoms and adjunctive medication use in the haloperidol group and greater prolactin elevation in the risperidone group. There was less weight gain with haloperidol initially but no significant differences between groups at endpoint. CONCLUSIONS: Relatively low doses of antipsychotic drugs lead to significant symptom amelioration in the majority of first-episode psychosis patients. In the long term, risperidone prevents relapse in more patients and for a longer time and also induces less abnormal movements than haloperidol.