OBJECTIVES: To further characterize the clinical profile of long-term treatment with aripiprazole once-monthly 400 mg (AOM 400) by examining patient-centered outcomes in adults with schizophrenia. METHODS: Data are from 2 separate studies: a 52-week, multicenter, randomized, double-blind, placebo-controlled study and a 38-week, multicenter, randomized, double-blind, active-controlled study that evaluated the clinical profile of AOM 400 as maintenance treatment in patients with schizophrenia. The studies were conducted from July 2008 through February 2011 and from September 2008 through August 2012, respectively. Both studies included the Drug Attitude Inventory (DAI), the Medication Adherence Questionnaire (MAQ), the Patient Satisfaction with Medication Questionnaire, and a resource utilization and hospitalization form as prespecified patient-centered endpoints. RESULTS: A total of 710 patients entered the oral stabilization phase in the 52-week study, and 403 patients were randomized to double-blind treatment. The corresponding sample sizes in the 38-week study were 842 and 662, respectively. In both studies, mean DAI and MAQ scores remained stable across all treatment phases; mean changes from baseline during the double-blind phase were not significantly different between treatment arms. Treatment satisfaction remained high throughout both studies, and most patients reported no or fewer side effects with AOM 400 relative to their prior medication. Most patients did not have unscheduled outpatient visits or hospitalizations throughout the studies. CONCLUSIONS: Data from 2 randomized, double-blind studies indicated that patient perceptions about treatment satisfaction, side effects, and medication adherence were maintained in patients with schizophrenia receiving maintenance treatment with AOM 400. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00705783, NCT00706654.
RCT Entities:
OBJECTIVES: To further characterize the clinical profile of long-term treatment with aripiprazole once-monthly 400 mg (AOM 400) by examining patient-centered outcomes in adults with schizophrenia. METHODS: Data are from 2 separate studies: a 52-week, multicenter, randomized, double-blind, placebo-controlled study and a 38-week, multicenter, randomized, double-blind, active-controlled study that evaluated the clinical profile of AOM 400 as maintenance treatment in patients with schizophrenia. The studies were conducted from July 2008 through February 2011 and from September 2008 through August 2012, respectively. Both studies included the Drug Attitude Inventory (DAI), the Medication Adherence Questionnaire (MAQ), the Patient Satisfaction with Medication Questionnaire, and a resource utilization and hospitalization form as prespecified patient-centered endpoints. RESULTS: A total of 710 patients entered the oral stabilization phase in the 52-week study, and 403 patients were randomized to double-blind treatment. The corresponding sample sizes in the 38-week study were 842 and 662, respectively. In both studies, mean DAI and MAQ scores remained stable across all treatment phases; mean changes from baseline during the double-blind phase were not significantly different between treatment arms. Treatment satisfaction remained high throughout both studies, and most patients reported no or fewer side effects with AOM 400 relative to their prior medication. Most patients did not have unscheduled outpatient visits or hospitalizations throughout the studies. CONCLUSIONS: Data from 2 randomized, double-blind studies indicated that patient perceptions about treatment satisfaction, side effects, and medication adherence were maintained in patients with schizophrenia receiving maintenance treatment with AOM 400. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00705783, NCT00706654.