Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (ARRIVE- EU)
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.
Drug: Aripiprazole (Abilify®) IM Depot Injection
Drug: Oral 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, Europe, Canada and Asia|
- 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.
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
- Change From Baseline in PANSS Positive and Negative Subscale Scores [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
- Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients.
- Clinical Global Impression of Improvement (CGI-I) Score [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
|Study Start Date:||January 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Aripiprazole IM depot injection
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary.
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. Participants 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 2014.
Other Name: ABILIFY®Drug: Oral aripiprazole
Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509053
|Brugge, Belgium, 8310|
|Bruxelles, Belgium, 1160|
|Kortenberg, Belgium, 3070|
|Liège, Belgium, 4000|
|Lovech, Bulgaria, 5500|
|Novi Iskar, Bulgaria, 1282|
|Pazardjik, Bulgaria, 4400|
|Tzerova Koria, Bulgaria, 5047|
|Canada, British Columbia|
|Penticton, British Columbia, Canada, V2A 4M4|
|Chatham, Ontario, Canada, N7M 5L9|
|Study Director:||Tim Peters-Strickland||Otsuka Pharmaceutical Development & Commercialization, Inc.|