Abstract
BACKGROUND: Schizophrenia is a chronic and disabling psychiatric disorder characterized by poor treatment adherence, often leading to relapse and functional decline. Long-acting injectable antipsychotics (LAIs), such as aripiprazole once-monthly (AOM), offer a potential solution by improving adherence and reducing relapse rates. This study evaluates the clinical effectiveness, safety, tolerability, and patient satisfaction in individuals with schizophrenia who transitioned from oral standard-of-care (SOC) atypical antipsychotics to AOM over a six-month period. METHODS: An open-label, single-arm, mirror-image study design was employed. Forty adult patients diagnosed with schizophrenia and previously stabilized on oral antipsychotics for at least two months were enrolled. Following a retrospective assessment of a six-month oral treatment period, patients were prospectively followed for six months after switching to AOM. Clinical assessments included the Investigator's Assessment Questionnaire (IAQ), Clinical Global Impression-Severity (CGI-S) scale, and the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4). Adverse effects were monitored via self-report and clinician-rated tools. RESULTS: Twenty-five patients completed at least the first follow-up visit. A statistically significant improvement in IAQ scores was observed over time, indicating enhanced global clinical effectiveness (p=0.010 at six months). CGI-S scores also significantly decreased, reflecting reduced illness severity (p<0.001 at six months). Patient satisfaction, measured by TSQM, increased significantly at three and six months (p<0.001). AOM was well-tolerated, with only minor, non-significant changes in weight gain, extrapyramidal symptoms, and prolactin levels. Notably, negative symptom scores showed a modest but statistically significant improvement (p=0.032). Only five patients (18%) reported adverse events, mostly with moderate impact, and no treatment discontinuation was recorded. CONCLUSIONS: Transitioning to AOM from oral antipsychotics in schizophrenia patients was associated with significant improvements in clinical outcomes, symptom severity, and treatment satisfaction, with a favorable safety and tolerability profile. These findings support the use of AOM in early-stage schizophrenia and highlight its potential to enhance long-term adherence and functional recovery. Further long-term studies are warranted to assess the durability of these benefits and their impact on relapse prevention and quality of life.