Objective: The purpose was to carry out a naturalistic study on efficacy, safety and tolerability of aripiprazole during treatment of schizophrenia. Fifty-one patients with an ICD-10 diagnosis of schizophrenia and partial responders to prior antipsychotic medication were offered treatment with aripiprazole as monotherapy or in combination their prior medication. Inclusion criteria were lack of therapeutic effect or adverse events on former antipsychotic treatment.
Method: Six-month open multicentre naturalistic study with prospective assessments including Body Mass Index (BMI), Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Improvment, Global Assessment of Functioning Scale (GAF) and adverse events.
Results: A statistically significant improvement in the different measures of psychopathology and global functioning (CGI-S reduction 34.7%; GAF improvement 14%) was shown in combination with a statistically significant reduction in BMI of 2.9%. Nine patients (17.6%) did not complete the 6-month treatment.
Conclusion: In an open multicentre naturalistic study, aripiprazole showed to improve the severity of psychotic symptoms and the global level of functioning. However, many of the patients (47%) were also given another antipsychotic drug at the same time. Also, high compliance and few side effects were reported. However, because of the study design, the results must be interpreted conservatively.