Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (ARRIVE- EU)
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).
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.|