Trial Outcomes & Findings for Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole (NCT NCT01552772)
NCT ID: NCT01552772
Last Updated: 2014-10-10
Results Overview
An 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 study physician. 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. TEAE stands for treatment emergent adverse events.
COMPLETED
PHASE1
60 participants
From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).
2014-10-10
Participant Flow
Trial to assess the safety and tolerability of aripiprazole intramuscular (IM) depot as an adjunctive therapy in adults with schizophrenia who were stabilized on any one of the atypical oral antipsychotics other than aripiprazole. In the United States, the trial was conducted in 60 enrolled participants and were screened in 12 centres.
The study consisted of a 30-day Screening period, a treatment phase of 28 days, and a Follow-up at 30 days after the last trial visit. Participants must have been stabilized on one of the following atypical oral antipsychotic medications for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone.
Participant milestones
| Measure |
Aripiprazole IM Depot 400mg
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Aripiprazole IM Depot 400mg
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
Baseline Characteristics
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
Baseline characteristics by cohort
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
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|---|---|
|
Age, Continuous
|
43.2 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
33.0 • n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
67.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).Population: The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.
An 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 study physician. 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. TEAE stands for treatment emergent adverse events.
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
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|---|---|
|
Number of Participants With Adverse Events (AE).
Participants with TEAE
|
35 Participants
|
|
Number of Participants With Adverse Events (AE).
Participants with serious TEAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).Population: The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
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).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
Week 1 (N= 59)
|
-2.42 Units on a scale
Standard Deviation 5.57
|
|
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
Week 2 (N= 56)
|
-2.86 Units on a scale
Standard Deviation 7.98
|
|
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
Week 4 (N= 57)
|
-3.82 Units on a scale
Standard Deviation 8.34
|
|
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
Last visit (N= 59)
|
-3.68 Units on a scale
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2 and 4Population: The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.
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).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
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|---|---|
|
Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
Week 1 (N= 59)
|
-2.42 Units on a scale
Standard Deviation 5.91
|
|
Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
Week 2 (N= 59)
|
-2.80 Units on a scale
Standard Deviation 7.83
|
|
Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
Week 4 (N= 59)
|
-3.68 Units on a scale
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).Population: The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
The Positive and Negative Syndrome Scale (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 total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
Week 1 (N= 59)
|
-0.81 Units on a scale
Standard Deviation 2.45
|
|
Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
Week 2 (N= 56)
|
-0.79 Units on a scale
Standard Deviation 3.37
|
|
Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
Week 4 (N= 57)
|
-1.28 Units on a scale
Standard Deviation 2.89
|
|
Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
Last visit (N= 59)
|
-1.25 Units on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2 and 4Population: The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
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 total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
Week 1 (N= 59)
|
-0.81 Units on a scale
Standard Deviation 2.45
|
|
Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
Week 2 (N= 59)
|
-0.78 Units on a scale
Standard Deviation 3.29
|
|
Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
Week 4 (N= 59)
|
-1.25 Units on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).Population: The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
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 total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
Week 1 (N= 59)
|
-0.78 Units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
Week 2 (N= 56)
|
-1.14 Units on a scale
Standard Deviation 2.88
|
|
Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
Week 4 (N= 57)
|
-0.96 Units on a scale
Standard Deviation 2.88
|
|
Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
Last visit (N= 59)
|
-0.92 Units on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2 and 4Population: The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
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 total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
Week 1 (N= 59)
|
-0.78 Units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
Week 2 (N= 59)
|
-1.08 Units on a scale
Standard Deviation 2.82
|
|
Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
Week 4 (N= 59)
|
-0.92 Units on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and Last visit (Day 28).Population: The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
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.
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
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|---|---|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
Week 1 (N= 59)
|
0.02 Units on a scale
Standard Deviation 0.39
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
Week 2 (N= 56)
|
-0.09 Units on a scale
Standard Deviation 0.35
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
Week 4 (N= 57)
|
-1.14 Units on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
Last visit (N= 59)
|
-1.14 Units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2 and 4.Population: The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator 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.
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Change From Baseline in CGI-S Score in LOCF Data.
Week 1 (N= 59)
|
0.02 Units on a scale
Standard Deviation 0.39
|
|
Change From Baseline in CGI-S Score in LOCF Data.
Week 2 (N= 59)
|
-0.08 Units on a scale
Standard Deviation 0.34
|
|
Change From Baseline in CGI-S Score in LOCF Data.
Week 4 (N= 59)
|
-0.14 Units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and Last visit (Day 28).Population: The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
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.
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
Week 1 (N= 59)
|
3.85 Units on a scale
Standard Deviation 0.45
|
|
Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
Week 2 (N= 56)
|
3.70 Units on a scale
Standard Deviation 0.57
|
|
Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
Week 4 (N= 57)
|
3.56 Units on a scale
Standard Deviation 0.78
|
|
Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
Last visit (N= 59)
|
3.58 Units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Week 1, 2 and 4Population: The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (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.
Outcome measures
| Measure |
Aripiprazole IM Depot 400mg
n=60 Participants
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
CGI-I Scale Score in LOCF Data.
Week 1 (N= 59)
|
3.85 Units on a scale
Standard Deviation 0.45
|
|
CGI-I Scale Score in LOCF Data.
Week 2 (N= 59)
|
3.69 Units on a scale
Standard Deviation 0.56
|
|
CGI-I Scale Score in LOCF Data.
Week 4 (N= 59)
|
3.58 Units on a scale
Standard Deviation 0.77
|
Adverse Events
Aripiprazole IM Depot 400mg
Serious adverse events
| Measure |
Aripiprazole IM Depot 400mg
n=60 participants at risk
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Psychiatric disorders
Suicide Attempt
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
Other adverse events
| Measure |
Aripiprazole IM Depot 400mg
n=60 participants at risk
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
|
|---|---|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
4/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Chest pain
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Fatigue
|
5.0%
3/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Injection site pain
|
6.7%
4/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Irritability
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Malaise
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
3/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Investigations
Heart rate increased
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Investigations
Weight increased
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Akathisia
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Disturbance in attention
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Dystonia
|
5.0%
3/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Sedation
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Nervous system disorders
Tremor
|
3.3%
2/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Psychiatric disorders
Impatience
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Psychiatric disorders
Insomnia
|
5.0%
3/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Psychiatric disorders
Restlessness
|
5.0%
3/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Renal and urinary disorders
Pyuria
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place