Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (ARRIVE- EU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01509053|
Recruitment Status : Terminated
First Posted : January 12, 2012
Results First Posted : January 16, 2014
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole (Abilify®) IM Depot Injection Drug: Oral aripiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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).
- Comparison of Inpatient Psychiatric Hospitalization Rates [ Time Frame: Retrospective period Months 4-6; Prospective period Months 4-6 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|