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

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ClinicalTrials.gov Identifier: NCT01432444
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : March 27, 2015
Last Update Posted : May 7, 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
Intervention Drug: Aripiprazole (Abilify®) IM Depot Injection
Enrollment 493
Recruitment Details This study assessed hospitalization rates in adults with schizophrenia treated prospectively for 6 months with aripiprazole intramuscular depot compared with 6 month retrospective treatment with oral antipsychotics. The study comprised 3 phases: Tolerability/Cross-titration (Phase A), Open-label Aripiprazole (Phase B), Extension (Phase C).
Pre-assignment Details 493 participants were enrolled, 325 of which had no history of tolerating oral aripiprazole entered Phase A, all participants completed Phase A combined with remainder of participants to enter Phase B. All outcome measures were assessed in Phase B.
Arm/Group Title Tolerability/Cross-titration Phase (Phase A) Open-label Aripiprazole IM Depot Treatment Phase (Phase B) Extension Phase (Phase C)
Hide Arm/Group Description In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study. In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers. Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
Period Title: Tolerability/Cross-titration Phase
Started 325 0 0
Completed 265 0 0
Not Completed 60 0 0
Reason Not Completed
Lost to Follow-up             10             0             0
Adverse Event             16             0             0
Met Withdrawal Criteria             5             0             0
Physician Decision             8             0             0
Withdrawal by Subject             15             0             0
Protocol Deviation             1             0             0
Lack of Efficacy             5             0             0
Period Title: Treatment Phase
Started 0 433 0
Completed 0 293 0
Not Completed 0 140 0
Reason Not Completed
Lost to Follow-up             0             33             0
Adverse Event             0             37             0
Met Withdrawal Criteria             0             11             0
Physician Decision             0             5             0
Withdrawal by Subject             0             41             0
Protocol Deviation             0             3             0
Lack of Efficacy             0             10             0
Period Title: Extension Phase
Started 0 0 192
Completed 0 0 0
Not Completed 0 0 192
Reason Not Completed
Lost to Follow-up             0             0             17
Adverse Event             0             0             10
Sponsor Discontinued Trial             0             0             7
Met Withdrawal Criteria             0             0             144
Physician Decision             0             0             1
Withdrawal by Subject             0             0             13
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Baseline Participants 433
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 433 participants
42.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants
Female
132
  30.5%
Male
301
  69.5%
1.Primary Outcome
Title Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
Hide Description The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ 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. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).
Time Frame Retrospective period Months 4-6; Prospective period Months 4-6
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 336
Measure Type: Number
Unit of Measure: participants
Retrospective period 91
Prospective period 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Comments Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments P-value was derived from Exact McNemar test.
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
Hide Description The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 427
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N= 390) -7.9  (14.0)
Week 12 (N= 410) -8.4  (15.6)
Week 24 (N= 410) -8.4  (17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Comments Statistical analyses for Week 4, 12 and 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Derived from T-test of Mean=0.
Method t-test
Comments Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.
3.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Score.
Hide Description The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 427
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N= 390) -2.7  (4.4)
Week 12 (N= 410) -2.9  (4.9)
Week 24 (N= 410) -3.0  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Comments Statistical analyses for Week 4, Week 12 and Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Derived from T-test of Mean=0.
Method t-test, 2 sided
Comments Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.
4.Secondary Outcome
Title Change From Baseline in PANSS Negative Subscale Score.
Hide Description The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 427
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 -1.7  (4.6)
Week 12 -1.6  (5.1)
Week 24 -1.6  (5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Comments Statistical analysis for Week 4, 12 and 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Derived from T-test of Mean=0.
Method t-test, 2 sided
Comments Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
Hide Description The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N= 391) -0.3  (0.8)
Week 12 (N= 410) -0.4  (0.9)
Week 24 (N= 410) -0.5  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Comments Statistical analysEs for Week 4, 12 and 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Derived from t-test of mean=0.
Method t-test
Comments [Not Specified]
6.Secondary Outcome
Title Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
Hide Description The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
Time Frame Week 4, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Hide Arm/Group Description:
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
Overall Number of Participants Analyzed 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N= 283) 2.9  (0.9)
Week 12 (N= 293) 2.7  (1.0)
Week 24 (N= 293) 2.5  (1.0)
Time Frame Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
Adverse Event Reporting Description 431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
 
Arm/Group Title Open-label Aripiprazole IM Depot Treatment Phase (Phase B) Extension Phase (Phase C)
Hide Arm/Group Description In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers. Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
All-Cause Mortality
Open-label Aripiprazole IM Depot Treatment Phase (Phase B) Extension Phase (Phase C)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Aripiprazole IM Depot Treatment Phase (Phase B) Extension Phase (Phase C)
Affected / at Risk (%) Affected / at Risk (%)
Total   61/431 (14.15%)   19/192 (9.90%) 
Cardiac disorders     
Acute myocardial infarction * 1  1/431 (0.23%)  0/192 (0.00%) 
Angina pectoris * 1  0/431 (0.00%)  1/192 (0.52%) 
Cardio-respiratory arrest * 1  0/431 (0.00%)  1/192 (0.52%) 
Myocardial infarction * 1  1/431 (0.23%)  0/192 (0.00%) 
Sinus tachycardia * 1  1/431 (0.23%)  0/192 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage * 1  1/431 (0.23%)  0/192 (0.00%) 
General disorders     
Asthenia * 1  1/431 (0.23%)  0/192 (0.00%) 
Chest pain * 1  1/431 (0.23%)  0/192 (0.00%) 
Non-cardiac chest pain * 1  1/431 (0.23%)  0/192 (0.00%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/431 (0.23%)  0/192 (0.00%) 
Hepatitis acute * 1  0/431 (0.00%)  1/192 (0.52%) 
Infections and infestations     
Lobar pneumonia * 1  1/431 (0.23%)  0/192 (0.00%) 
Pneumonia * 1  1/431 (0.23%)  0/192 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  2/431 (0.46%)  0/192 (0.00%) 
Craniocerebral injury * 1  1/431 (0.23%)  0/192 (0.00%) 
Investigations     
Blood glucose increased * 1  1/431 (0.23%)  0/192 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/431 (0.23%)  0/192 (0.00%) 
Hyperglycaemia * 1  1/431 (0.23%)  0/192 (0.00%) 
Hypoglycaemia * 1  1/431 (0.23%)  0/192 (0.00%) 
Hyponatraemia * 1  1/431 (0.23%)  0/192 (0.00%) 
Hypovolaemia * 1  1/431 (0.23%)  0/192 (0.00%) 
Type 2 diabetis mellitus * 1  1/431 (0.23%)  1/192 (0.52%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis * 1  2/431 (0.46%)  0/192 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal cell carcinoma * 1  1/431 (0.23%)  0/192 (0.00%) 
Nervous system disorders     
Akathisia * 1  1/431 (0.23%)  0/192 (0.00%) 
Convulsion * 1  4/431 (0.93%)  1/192 (0.52%) 
Hypoxic-ischaemic encephalopathy * 1  0/431 (0.00%)  1/192 (0.52%) 
Sedation * 1  1/431 (0.23%)  0/192 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  2/431 (0.46%)  0/192 (0.00%) 
Psychiatric disorders     
Acute psychosis * 1  1/431 (0.23%)  0/192 (0.00%) 
Anxiety * 1  1/431 (0.23%)  0/192 (0.00%) 
Depression * 1  2/431 (0.46%)  1/192 (0.52%) 
Psychotic disorder * 1  8/431 (1.86%)  3/192 (1.56%) 
Schizophrenia * 1  11/431 (2.55%)  6/192 (3.13%) 
Schizophrenia, paranoid type * 1  14/431 (3.25%)  3/192 (1.56%) 
Schizophrenia, undifferentiated type * 1  0/431 (0.00%)  1/192 (0.52%) 
Suicidal ideation * 1  6/431 (1.39%)  1/192 (0.52%) 
Suicide attempt * 1  3/431 (0.70%)  1/192 (0.52%) 
Reproductive system and breast disorders     
Penile oedema * 1  1/431 (0.23%)  0/192 (0.00%) 
Scrotal oedema * 1  1/431 (0.23%)  0/192 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/431 (0.23%)  0/192 (0.00%) 
Dyspnoea * 1  0/431 (0.00%)  1/192 (0.52%) 
Respiratory failure * 1  1/431 (0.23%)  0/192 (0.00%) 
Vascular disorders     
Hypertension * 1  2/431 (0.46%)  0/192 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label Aripiprazole IM Depot Treatment Phase (Phase B) Extension Phase (Phase C)
Affected / at Risk (%) Affected / at Risk (%)
Total   60/431 (13.92%)   24/192 (12.50%) 
Investigations     
Weight increased * 1  10/431 (2.32%)  11/192 (5.73%) 
Nervous system disorders     
Akathisia * 1  27/431 (6.26%)  9/192 (4.69%) 
Psychiatric disorders     
Insomnia * 1  29/431 (6.73%)  6/192 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01432444     History of Changes
Other Study ID Numbers: 31-11-283
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: December 19, 2014
Results First Posted: March 27, 2015
Last Update Posted: May 7, 2015