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Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01683058
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Collaborators:
H. Lundbeck A/S
Otsuka America Pharmaceutical
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 IM Depot
Enrollment 74
Recruitment Details A multicenter, open-label, single-arm rollover trial designed to demonstrate the safety of aripiprazole intramuscular (IM) depot [400 or 300 milligrams (mg)] for the acute treatment of participants with schizophrenia, who met completion criteria in the registration trial NCT01663532. 74 participants were enrolled in this trial.
Pre-assignment Details Participants entered this trial after completing the Week 12/Early Termination (ET) visit of trial NCT01663532 as it served as the Baseline evaluations for this trial.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Period Title: Overall Study
Started 74
Completed 45
Not Completed 29
Reason Not Completed
Lost to Follow-up             9
Adverse Event             6
Subject Met Withdrawal Criteria             5
Withdrawal by Subject             7
Lack of Efficacy             2
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants
43.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
18
  24.3%
Male
56
  75.7%
1.Primary Outcome
Title Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
Hide Description A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: Percentage of participants
Participants with TEAEs 66.2
Participants with serious TEAEs 6.8
Participants with severe TEAEs 8.1
Participants discontinued IMP due to AEs 8.1
Deaths 0.0
2.Secondary Outcome
Title Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N= 69) -0.1  (2.3)
Week 8 (N= 61) -0.1  (2.2)
Week 12 (N= 57) -0.3  (2.0)
Week 16 (N= 52) 0.7  (4.7)
Week 20 (N= 44) 0.3  (2.0)
Week 24 (N= 45) 0.0  (0.0)
Last Visit (N= 71) 0.6  (4.2)
3.Secondary Outcome
Title Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)
Hide Description The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 72
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (N= 66) 0.19  (1.51)
Week 24 (N= 70) 0.04  (1.62)
4.Secondary Outcome
Title Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
Hide Description EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (N= 65) -0.06  (0.81)
Week 24 (N= 70) 0.07  (1.28)
5.Secondary Outcome
Title Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)
Hide Description The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (N= 65) 0.19  (0.73)
Week 24 (N= 70) 0.14  (0.91)
6.Secondary Outcome
Title Mean Change in Body Temperature From Baseline in All Participants.
Hide Description The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: °C
Week 4 (N= 69) 0.1  (0.4)
Week 8 (N= 61) -0.0  (0.4)
Week 12 (N= 58) 0.0  (0.4)
Week 16 (N= 53) 0.0  (0.3)
Week 20 (N= 44) 0.1  (0.4)
Week 24 (N= 45) 0.1  (0.4)
Last visit (N= 72) 0.0  (0.4)
7.Secondary Outcome
Title Mean Change in Heart Rate Supine From Baseline in All Participants.
Hide Description The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: beats/min
Week 4 (N= 69) 3.8  (10.9)
Week 8 (N= 61) 2.3  (11.2)
Week 12 (N= 58) 1.3  (10.8)
Week 16 (N= 53) 4.7  (12.0)
Week 20 (N= 44) 3.6  (9.8)
Week 24 (N= 45) 1.7  (12.7)
Last visit (N= 72) 3.4  (12.1)
8.Secondary Outcome
Title Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.
Hide Description The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 4 (N= 69) 1.9  (12.8)
Week 8 (N= 61) 1.3  (12.2)
Week 12 (N= 58) -0.2  (12.4)
Week 16 (N= 53) 2.0  (12.4)
Week 20 (N= 44) 4.8  (12.8)
Week 24 (N= 45) 0.7  (11.3)
Last visit (N= 72) 0.4  (13.1)
9.Secondary Outcome
Title Mean Change in Diastolic Supine BP From Baseline in All Participants.
Hide Description The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 4 (N= 69) 0.1  (8.6)
Week 8 (N= 61) -1.3  (8.1)
Week 12 (N= 58) -0.9  (7.7)
Week 16 (N= 53) 0.3  (8.6)
Week 20 (N= 44) -0.0  (9.6)
Week 24 (N= 45) 0.4  (9.7)
Last visit (N= 72) 0.5  (9.9)
10.Secondary Outcome
Title Mean Change in Heart Rate From Baseline in All Participants.
Hide Description The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: beats/min
Week 4 (N= 69) 1.2  (9.1)
Week 8 (N= 61) 1.4  (10.1)
Week 12 (N= 58) -1.1  (10.8)
Week 16 (N= 53) 4.3  (12.0)
Week 20 (N= 44) 3.3  (10.1)
Week 24 (N= 45) 0.6  (13.6)
Last visit (N= 72) 1.9  (13.0)
11.Secondary Outcome
Title Mean Change in Systolic BP From Baseline in All Participants.
Hide Description The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 4 (N= 69) -0.1  (13.0)
Week 8 (N= 61) -0.3  (11.3)
Week 12 (N= 58) -0.7  (11.3)
Week 16 (N= 53) 1.6  (12.1)
Week 20 (N= 44) 1.0  (11.5)
Week 24 (N= 45) -0.4  (12.5)
Last visit (N= 72) -0.7  (13.4)
12.Secondary Outcome
Title Mean Change in Diastolic BP From Baseline in All Participants.
Hide Description The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 4 (N= 69) -0.9  (9.7)
Week 8 (N= 61) -1.7  (9.4)
Week 12 (N= 58) -0.2  (7.9)
Week 16 (N= 53) 0.8  (7.8)
Week 20 (N= 44) -0.2  (10.0)
Week 24 (N= 45) 0.4  (9.8)
Last visit (N= 72) 1.4  (10.0)
13.Secondary Outcome
Title Mean Change in Ventricular Rate From Baseline in All Participants.
Hide Description The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: Beats/min
Week 12 (N= 56) -1.5  (12.0)
Week 24 (N= 43) -1.1  (12.3)
Last visit (N= 70) -0.1  (13.7)
14.Secondary Outcome
Title Mean Change in PR Interval From Baseline in All Participants.
Hide Description The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) 3.5  (11.1)
Week 24 (N= 43) 0.5  (12.5)
Last visit (N= 70) 0.9  (11.6)
15.Secondary Outcome
Title Mean Change in RR Interval From Baseline in All Participants.
Hide Description The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) 23.7  (140.9)
Week 24 (N= 43) 23.3  (152.2)
Last visit (N= 70) 8.0  (158.4)
16.Secondary Outcome
Title Mean Change in QRS Interval From Baseline in All Participants.
Hide Description The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) -0.1  (5.0)
Week 24 (N= 43) 0.4  (5.3)
Last visit (N= 70) 0.0  (5.7)
17.Secondary Outcome
Title Mean Change in QT Interval From Baseline in All Participants.
Hide Description The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) 3.1  (21.5)
Week 24 (N= 43) 1.5  (24.9)
Last visit (N= 70) 1.0  (25.7)
18.Secondary Outcome
Title Mean Change in QTcB Interval From Baseline in All Participants.
Hide Description The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) -1.6  (20.2)
Week 24 (N= 43) -2.4  (19.4)
Last visit (N= 70) 0.3  (19.0)
19.Secondary Outcome
Title Mean Change in QTcF Interval From Baseline in All Participants.
Hide Description The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) -0.2  (13.9)
Week 24 (N= 43) -1.3  (14.0)
Last visit (N= 70) 0.3  (12.9)
20.Secondary Outcome
Title Mean Change in QTcN Interval From Baseline in All Participants.
Hide Description The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: msec
Week 12 (N= 56) -0.5  (14.7)
Week 24 (N= 43) -1.7  (14.3)
Last visit (N= 70) 0.3  (13.4)
21.Secondary Outcome
Title Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.
Hide Description Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: Kg
Week 12 (N= 57) -0.1  (4.5)
Week 24 (N= 44) 1.3  (6.0)
Last visit (N= 71) 0.5  (5.8)
22.Secondary Outcome
Title Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.
Hide Description Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: Kg/m2
Week 12 (N= 57) -0.0  (1.5)
Week 24 (N= 44) 0.5  (2.0)
Last visit (N= 71) 0.2  (1.9)
23.Secondary Outcome
Title Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.
Hide Description Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included.
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: cm
Week 24 (N= 44) 1.6  (6.6)
Last visit (N= 64) 1.3  (6.0)
24.Secondary Outcome
Title Number of Participants With Clinically Relevant Laboratory Values.
Hide Description The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: participants
0
25.Secondary Outcome
Title Number of Participants With Clinically Relevant Physical Examination.
Hide Description The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.
Time Frame Baseline to last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.
Arm/Group Title Aripiprazole IM Depot 400/ 300 mg
Hide Arm/Group Description:
All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: participants
0
Time Frame AEs were recorded from the time the ICF was signed until follow-up for safety 14 (±2) days after the last trial visit.
Adverse Event Reporting Description A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
 
Arm/Group Title Aripiprazole IM Depot 400/300 mg
Hide Arm/Group Description All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
All-Cause Mortality
Aripiprazole IM Depot 400/300 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole IM Depot 400/300 mg
Affected / at Risk (%)
Total   5/74 (6.76%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/74 (1.35%) 
Psychiatric disorders   
Depression * 1  2/74 (2.70%) 
Schizophrenia * 1  2/74 (2.70%) 
Suicidal ideation * 1  1/74 (1.35%) 
*
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%
Aripiprazole IM Depot 400/300 mg
Affected / at Risk (%)
Total   40/74 (54.05%) 
Investigations   
Weight decreased * 1  6/74 (8.11%) 
Weight increased * 1  22/74 (29.73%) 
Metabolism and nutrition disorders   
Hyperlipidaemia * 1  4/74 (5.41%) 
Nervous system disorders   
Akathisia * 1  9/74 (12.16%) 
Headache * 1  6/74 (8.11%) 
*
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
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01683058     History of Changes
Other Study ID Numbers: 31-12-297
First Submitted: September 7, 2012
First Posted: September 11, 2012
Results First Submitted: December 23, 2014
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015