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Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

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: NCT01909466
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : June 2, 2015
Last Update Posted : July 1, 2015
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Mental Disorder
Nervous System Diseases
Intervention Drug: Aripiprazole, OPC-14597
Enrollment 141
Recruitment Details An open-label, multiple dose, multiple-site trial of adult participants with schizophrenia for the first application of aripiprazole intramuscular (IM) depot 400 mg in the gluteal or deltoid muscle (1:1 ratio) followed by 4 monthly administrations to the deltoid muscle site in all participants.
Pre-assignment Details Prior to the trial, the participants were stabilized for at least 14 days on their current oral antipsychotic medication prior to administration of the first aripiprazole IM depot.
Arm/Group Title Gluteal/Deltoid Deltoid/Deltoid
Hide Arm/Group Description Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days. Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Period Title: Overall Study
Started 68 73
Completed 46 50
Not Completed 22 23
Reason Not Completed
Lost to Follow-up             5             7
Adverse Event             3             4
Met Withdrawal Criteria             0             3
Physician Decision             2             0
Withdrawal by Subject             11             9
Lack of Efficacy             1             0
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Baseline Participants 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants
43.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants
Female
32
  22.7%
Male
109
  77.3%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs).
Hide Description AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time Frame AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Measure Type: Number
Unit of Measure: participants
Participants with TEAEs 112
Participants with serious TEAEs 4
Participants with non-serious TEAEs 112
Participants with severe TEAEs 2
2.Primary Outcome
Title Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.
Hide Description Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection.
Time Frame Days 1 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
First injection (Day 1) 2.0  (4.4)
Last injection (Day 113) 1.2  (3.4)
3.Primary Outcome
Title Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).
Hide Description Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.
Time Frame Baseline to Last Visit (Day 141)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 135) 0.0  (0.0)
Week 2 (N= 132) 0.0  (0.0)
Week 3 (N= 131) 0.0  (0.0)
Week 4 (N= 129) 0.2  (1.3)
Week 8 (N= 112) 0.1  (1.0)
Week 12 (N= 109) 0.1  (1.1)
Week 16 (N= 99) 0.0  (0.0)
Week 17 (N=100) 0.0  (0.0)
Week 18 (N= 98) 0.0  (0.0)
Week 19 (N= 99) 0.0  (0.0)
Week 20 (N= 97) 0.0  (0.0)
Last Visit (N= 136) 0.1  (0.6)
4.Primary Outcome
Title Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).
Hide Description The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1(N= 135) 0.01  (0.89)
Week 2 (N= 136) 0.04  (0.83)
Week 3 (N= 136) -0.02  (1.08)
Week 4 (N= 136) 0.01  (0.98)
Week 8 (N= 136) 0.02  (1.11)
Week 12 (N= 136) 0.04  (1.17)
Week 16 (N= 136) 0.07  (1.04)
Week 20 (N= 136) 0.07  (1.20)
5.Primary Outcome
Title Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).
Hide Description The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1(N= 135) -0.03  (0.42)
Week 2 (N= 136) -0.05  (0.37)
Week 3 (N= 136) -0.01  (0.52)
Week 4 (N= 136) -0.03  (0.50)
Week 8 (N= 136) -0.05  (0.53)
Week 12 (N= 136) 0.00  (0.40)
Week 16 (N= 136) -0.03  (0.52)
Week 20 (N= 136) 0.03  (0.64)
6.Primary Outcome
Title Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).
Hide Description The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe).
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1(N=135) 0.03  (0.47)
Week 2 (N=136) 0.08  (0.50)
Week 3 (N=136) 0.08  (0.57)
Week 4 (N=136) 0.06  (0.47)
Week 8 (N=136) 0.11  (0.59)
Week 12 (N=136) 0.06  (0.51)
Week 16 (N=136) 0.06  (0.51)
Week 20 (N=136) 0.04  (0.47)
7.Secondary Outcome
Title Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.94  (9.42)
Week 20 (N= 128) -2.23  (10.95)
8.Secondary Outcome
Title Mean Change From Baseline in PANSS Positive Sub-scale Score.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. 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 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.14  (3.18)
Week 20 (N= 128) -0.52  (3.84)
9.Secondary Outcome
Title Mean Change From Baseline in PANSS Negative Sub-scale Score.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic 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 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.30  (3.56)
Week 20 (N= 128) -0.33  (3.79)
10.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.
Hide Description The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant 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 participants.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.02  (0.57)
Week 20 (N= 128) -0.09  (0.61)
11.Secondary Outcome
Title Clinical Global Impression-Improvement (CGI-I) Score.
Hide Description The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 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 Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) 3.86  (0.78)
Week 20 (N= 128) 3.70  (0.98)
12.Secondary Outcome
Title Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience).
Time Frame Baseline to Week 20+
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -1.17  (15.95)
Week 20 (N= 128) -0.81  (17.09)
13.Secondary Outcome
Title Mean Change From Baseline in Mental Functioning Score of SWN-S.
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.18  (4.85)
Week 20 (N= 128) 0.01  (4.83)
14.Secondary Outcome
Title Mean Change From Baseline in Self Control Score of SWN-S.
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.47  (3.90)
Week 20 (N= 128) -0.64  (4.14)
15.Secondary Outcome
Title Mean Change From Baseline in Physical Functioning Score of SWN-S.
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.39  (4.44)
Week 20 (N= 128) -0.37  (4.34)
16.Secondary Outcome
Title Mean Change From Baseline in Emotional Regulation Score of SWN-S.
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description:
Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) 0.30  (3.36)
Week 20 (N= 128) 0.46  (4.05)
17.Secondary Outcome
Title Mean Change From Baseline in Social Integration Score of SWN-S.
Hide Description The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
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Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (N= 128) -0.47  (4.28)
Week 20 (N= 128) -0.32  (4.43)
Time Frame Adverse events were reported from the signing of the ICF until follow-up for up to 28 days after the last dose of study medication.
Adverse Event Reporting Description A SAE was an untoward medical occurrence resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
 
Arm/Group Title Aripiprazole IM Depot 400 mg - Total
Hide Arm/Group Description Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
All-Cause Mortality
Aripiprazole IM Depot 400 mg - Total
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole IM Depot 400 mg - Total
Affected / at Risk (%)
Total   4/138 (2.90%) 
Cardiac disorders   
Atrial fibrillation * 1  1/138 (0.72%) 
Psychiatric disorders   
Psychotic disorder * 1  1/138 (0.72%) 
Schizophrenia * 1  2/138 (1.45%) 
*
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 mg - Total
Affected / at Risk (%)
Total   112/138 (81.16%) 
Gastrointestinal disorders   
Diarrhoea * 1  7/138 (5.07%) 
Dyspepsia * 1  9/138 (6.52%) 
Nausea * 1  9/138 (6.52%) 
Toothache * 1  11/138 (7.97%) 
General disorders   
Injection site pain * 1  38/138 (27.54%) 
Infections and infestations   
Upper respiratory tract infection * 1  11/138 (7.97%) 
Investigations   
Weight increased * 1  17/138 (12.32%) 
Nervous system disorders   
Akathisia * 1  11/138 (7.97%) 
Headache * 1  16/138 (11.59%) 
Psychiatric disorders   
Insomnia * 1  7/138 (5.07%) 
Restlessness * 1  8/138 (5.80%) 
*
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: NCT01909466     History of Changes
Other Study ID Numbers: 31-12-298
First Submitted: July 24, 2013
First Posted: July 26, 2013
Results First Submitted: March 19, 2015
Results First Posted: June 2, 2015
Last Update Posted: July 1, 2015