ABSTRACT
We investigated the efficacy and safety of aripiprazole in first-episode psychosis and explored the association between early response and later response to this medication. This was a 6-week, open-label, multicenter trial. The study population consisted of 59 patients with a DSM-IV diagnosis of a schizophreniform disorder, schizoaffective disorder, schizophrenia, or psychotic disorder not otherwise specified. The primary outcome measures were the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity scale. To assess the safety, we measured the drug-related adverse events, weight, and lipid-related variables. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the response status at weeks 2 and 3 to predict the subsequent response at week 6. Among the 59 participants, 38 were able to complete the 6-week trial. Treatment with aripiprazole resulted in significant improvement in the PANSS and Clinical Global Impression scores over time. The response rate (defined as a ≥30% decrease in the PANSS total score from baseline to the last observation) was 69.1%. The most accurate prediction of later response in terms of negative predictive value and specificity was a reduction in the PANSS total score from baseline to week 3 of at least 20%. Aripiprazole had a modest side effect burden and was characterized by a safe profile with respect to weight and metabolic side effects. These results indicate that aripiprazole is effective and safe in the treatment of first-episode psychosis. The response at week 3, rather than week 2, predicted the later response more accurately.
Subject(s)
Antipsychotic Agents/therapeutic use , Piperazines/therapeutic use , Psychotic Disorders/drug therapy , Quinolones/therapeutic use , Adolescent , Adult , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/adverse effects , Aripiprazole , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Piperazines/administration & dosage , Piperazines/adverse effects , Predictive Value of Tests , Psychiatric Status Rating Scales , Psychotic Disorders/psychology , Quinolones/administration & dosage , Quinolones/adverse effects , Republic of Korea , Treatment Outcome , Young AdultABSTRACT
OBJECTIVE: This study aimed to examine the effectiveness of quetiapine and the effects of dosage relates to its effectiveness on schizophrenia and schizoaffective disorder in a naturalistic setting in Korean people. METHODS: This study was a 24-week, open-label, non-comparative, naturalistic study of quetiapine in patients diagnosed with schizophrenia and schizoaffective disorder according to DSM-IV. We stratified the patients into mild [(clinical global impression severity (CGI-S) <4 at baseline)] and severe groups (CGI-S >/=4 at baseline). We investigated the response rate, defined as clinical global impression improvement (CGI-I) =2, in the severe group and the aggravation rate in the mild group using the last-observation-carried-forward (LOCF) and the Kaplan-Meier method (K-M). RESULTS: During the 24 weeks, 151 (18.4%) of the participants dropped out of the study. There was a significant decrease in the mean CGI-S score, from 4.5+/-1.1 at baseline to 2.8+/-1.1 at 24 weeks. The response rate of severe group was 54.5% (estimated by LOCF) and 73.3% (K-M estimated) at 24 weeks. All patients who completed the study had taken a mean quetiapine dosage of 507.9+/-245.9 mg daily. The decrease of CGI-S score in high-dose group (the maximum dose was 750 mg/d or above) was statistically significant than that in recommended-dose group (the maximum dose was less than 750 mg/d). CONCLUSION: This study demonstrated the long-term effectiveness of quetiapine in the treatment of schizophrenia and schizoaffective disorder in a naturalistic setting in Korean people. This study suggests that higher than recommended quetiapine dosages could be more effective in some patients.