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Trial record 22 of 408 for:    ARIPIPRAZOLE

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
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Aripiprazole (Abilify®) IM Depot Injection
Drug: Oral aripiprazole
Enrollment 30
Recruitment Details  
Pre-assignment Details This study included a Tolerability Assessment Phase A (if applicable), an Open-Label Aripiprazole IM Depot Phase B and an Open-Label Aripiprazole IM Depot Extension Phase C.
Arm/Group Title Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection
Hide Arm/Group Description 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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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 (C). Oral aripiprazole was available as rescue medication if necessary.
Period Title: Oral Aripirazole (Phase A)
Started 19
Completed 8
Not Completed 11
Reason Not Completed
Sponsor discontinued study             11
Period Title: Aripiprazole IM Depot Treatment Phase(B)
Started 19 [1]
Completed 3
Not Completed 16
Reason Not Completed
Adverse Event             1
Sponsor discontinued study             13
Subject was withdrawn by investigator             1
Subject withdrew consent             1
[1]
Includes 8 patients from Phase A + 11 patients who entered directly into Phase B.
Period Title: Aripiprazole IM Depot Extension Phase(C)
Started 3
Completed 0
Not Completed 3
Reason Not Completed
Sponsor discontinued study             3
Arm/Group Title All Participants
Hide Arm/Group Description 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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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 (C). Oral aripiprazole was available as rescue medication if necessary.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Baseline measures are based on all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
43.9  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
10
  33.3%
Male
20
  66.7%
1.Primary Outcome
Title Comparison of Inpatient Psychiatric Hospitalization Rates
Hide Description 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.
Time Frame Retrospective period Months 4-6; Prospective period Months 4-6
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.
Arm/Group Title Aripiprazole IM Depot Injection Standard of Care
Hide Arm/Group Description:
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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary.
Patients who received oral antipsychotic treatment as standard of care in clinical practice.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
Arm/Group Title Aripiprazole IM Depot Injection
Hide Arm/Group Description:
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 (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in PANSS Positive and Negative Subscale Scores
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
Arm/Group Title Aripiprazole IM Depot Injection
Hide Arm/Group Description:
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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Clinical Global Impression of Severity (CGI-S) Score
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
Arm/Group Title Aripiprazole IM Depot Injection
Hide Arm/Group Description:
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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Score
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.
Arm/Group Title Aripiprazole IM Depot Injection
Hide Arm/Group Description:
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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Aripiprazole (Phase A) Aripiprazole IM Depot (Phase B) Aripiprazole IM Depot (Phase C)
Hide Arm/Group Description 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 (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), 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. Oral aripiprazole was available as rescue medication if necessary. 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 (C). Oral aripiprazole was available as rescue medication if necessary.
All-Cause Mortality
Oral Aripiprazole (Phase A) Aripiprazole IM Depot (Phase B) Aripiprazole IM Depot (Phase C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Aripiprazole (Phase A) Aripiprazole IM Depot (Phase B) Aripiprazole IM Depot (Phase C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   1/19 (5.26%)   0/3 (0.00%) 
Hepatobiliary disorders       
Drug-induced liver injury   0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Psychiatric disorders       
Schizophrenia   0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Aripiprazole (Phase A) Aripiprazole IM Depot (Phase B) Aripiprazole IM Depot (Phase C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/19 (21.05%)   10/19 (52.63%)   1/3 (33.33%) 
Cardiac disorders       
Palpitations  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Gastrointestinal disorders       
Flatulence  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
General disorders       
Fatigue  1/19 (5.26%)  2/19 (10.53%)  0/3 (0.00%) 
Irritability  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Infections and infestations       
Bronchitis  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Investigations       
Alanine aminotransferase increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Aspartate aminotransferase increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Blood creatine phosphokinase increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Blood glucose increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Blood triglycerides increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Gamma-glutamyltransferase increased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Weight decreased  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  0/19 (0.00%)  1/19 (5.26%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders       
Back pain  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Musculoskeletal pain  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Nervous system disorders       
Somnolence  1/19 (5.26%)  1/19 (5.26%)  0/3 (0.00%) 
Psychiatric disorders       
Insomnia  3/19 (15.79%)  3/19 (15.79%)  0/3 (0.00%) 
Psychotic disorder  0/19 (0.00%)  1/19 (5.26%)  0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 800-562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01509053     History of Changes
Other Study ID Numbers: 31-11-284
First Submitted: December 13, 2011
First Posted: January 12, 2012
Results First Submitted: November 26, 2013
Results First Posted: January 16, 2014
Last Update Posted: March 4, 2015