drugset / Trial / NCT03730857

Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics

NCT03730857

Phase 1 Completed 111 enrolled Calo Psychiatric Center
RandomizedFactorialOpen-labelTreatment

Summary

Background: The aims of this study were to explore the relationship between early reduction in psychotic symptoms and the ultimate response in patients with schizophrenia treated by atypical antipsychotics, and to determine the best time to switch or maitain the regimen. PI also explore the possible predictors for the clinical response. Methods: One hundred eleven inpatients with acutely exacerbated schizophrenia were randomized to give optimal therapy of olanzapine, risperidone, and paliperidone in one-week run-in period and 12 weeks' intervention. All participants were assessed using Positive and Negative Syndrome Scale (PANSS). Early Response, defined as reduction of 25% in PANSS score, was examined at weeks 1, 2, 3, 4 and 8, and these ratings were used to predict ultimate response (25% PANSS reduction) at week 12. PI hypothesized that early treatment response at Week 1 or 2 could predict Week 12's treatment outcome.

Timeline

Start
2008-01
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olanzapine Small molecule 10 mg Oral
Comparator Olanzapine Small molecule 20 mg Oral
Comparator Paliperidone Unknown 6 mg Oral
Comparator Paliperidone Unknown 12 mg Oral
Comparator Risperidone Other / unclassified 4 mg Oral
Comparator Risperidone Other / unclassified 6 mg Oral

Indications