Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (ARRIVE US)
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting|
- The comparison of inpatient psychiatric hospitalization rates [ Time Frame: Retrospective period Months; 4-6 Prospective period Months 4-6 ] [ Designated as safety issue: No ]The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
- PANSS total score [ Time Frame: Day 0 to Week 24 ] [ Designated as safety issue: No ]
- PANSS positive and negative subscale scores [ Time Frame: Day 0 to Week 24 ] [ Designated as safety issue: No ]
- CGI-S score [ Time Frame: Day 0 to Week 24 ] [ Designated as safety issue: No ]
- CGI-I score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Aripiprazole IM depot injection 300 mg or 400 mg.
Drug: Aripiprazole (Abilify®) IM Depot Injection
400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.
Other Name: ABILIFY®
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
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|Study Director:||Kevin Cox, MD||Kevin.TC-Cox@otsuka-us.com|