Trial Outcomes & Findings for An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia (NCT NCT01646827)
NCT ID: NCT01646827
Last Updated: 2014-07-31
Results Overview
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Results posted on
2014-07-31
Participant Flow
This report presents results of a study on 37 adults with schizophrenia, conducted at 6 centers in the United States.
Participants were randomized 1:1 to receive a single dose of aripiprazole intramuscular (IM) depot (400 mg) in either the deltoid muscle or gluteal muscle according to the randomization schedule.
Participant milestones
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=19 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
45.9 Years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early terminationPopulation: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=16 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
|
170 ng/mL
Standard Deviation 58.6
|
136 ng/mL
Standard Deviation 70.3
|
PRIMARY outcome
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early terminationPopulation: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=16 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
AUC infinity (n=16,14)
|
7590 ng day/mL
Standard Deviation 2590
|
7920 ng day/mL
Standard Deviation 2580
|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
AUC 28 (n=16,17)
|
3120 ng day/mL
Standard Deviation 1150
|
2380 ng day/mL
Standard Deviation 1410
|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
AUC t (n=16,17)
|
7360 ng day/mL
Standard Deviation 2420
|
7340 ng day/mL
Standard Deviation 2360
|
PRIMARY outcome
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early terminationPopulation: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=16 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
|
51.7 ng/mL
Standard Deviation 23.3
|
34.6 ng/mL
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early terminationPopulation: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=16 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
AUC infinity (n=16,14)
|
2520 ng day/mL
Standard Deviation 836
|
2230 ng day/mL
Standard Deviation 630
|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
AUC 28 (n=16,17)
|
886 ng day/mL
Standard Deviation 445
|
538 ng day/mL
Standard Deviation 305
|
|
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
AUC t (n=16,17)
|
2420 ng day/mL
Standard Deviation 805
|
1990 ng day/mL
Standard Deviation 603
|
SECONDARY outcome
Timeframe: Starting at the time the ICF was signed to Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Safety was measured according to standard adverse event collection as described in the adverse event section of the results.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Subjects with TEAEs
|
14 Participants
|
18 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Subjects with serious TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Subjects with severe TEAEs
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 28, Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: \> upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Laboratory Values of Potential Clinical Relevance.
High fasting triglycerides (n=9,11)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Values of Potential Clinical Relevance.
High fasting glucose (n=9,11)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Values of Potential Clinical Relevance.
High prolactin (n=17,18)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Values of Potential Clinical Relevance.
Low absolute neutrophils (n=17,18)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Values of Potential Clinical Relevance.
High creatine phosphokinase (n=17,18)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as \>/= 20 mm Hg decrease in systolic blood pressure and \>/= 25 beats per minute increase in heart rate from supine to standing.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
Increase >/=15 mmHg in diastolic standing BP
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
Orthostatic hypotension
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Vital sign assessment included body temperature measured in centigrade(C). Temperatures \>=37.8°C and increase of \>= 1.1°C were recorded.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of \>/= 15 beats per minute were recorded.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Heart rate: Supine: increase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Heart rate: Supine: decrease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Heart rate: Standing: increase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Heart rate: Standing: decrease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and Day 126/Early terminationPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
premature ventricular contractions
|
2 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
T-wave inversions
|
2 Participants
|
2 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
Bradycardia and sinus bradycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
Abnormalities in QTc intervals
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14, Day 28 and last visitPopulation: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator's assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Day 1: 0.5 hour pre-dose (n=17, 18)
|
1.2 Units on a scale
Standard Deviation 3.4
|
0.8 Units on a scale
Standard Deviation 1.6
|
|
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Day 1: 1 hour post-dose (n=17, 18)
|
3.1 Units on a scale
Standard Deviation 7.3
|
1.7 Units on a scale
Standard Deviation 2.7
|
|
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Day 14 (n=16, 18)
|
1.3 Units on a scale
Standard Deviation 3.7
|
0.3 Units on a scale
Standard Deviation 0.8
|
|
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Day 28 (n=16, 18)
|
0.5 Units on a scale
Standard Deviation 1.1
|
0.5 Units on a scale
Standard Deviation 1.3
|
|
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Last visit (n=17, 18)
|
2.2 Units on a scale
Standard Deviation 7.2
|
0.5 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.Population: Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.
Outcome measures
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 Participants
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 18: Suicidality (n=16,14)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Screening: Suicidality (n=17,18)
|
4 Participants
|
7 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Screening: Suicidal behaviour (n=17,18)
|
2 Participants
|
5 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Screening: Suicidal ideation (n=17,18)
|
4 Participants
|
7 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Baseline: Suicidality (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Baseline: Suicidal behaviour (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Baseline: Suicidal ideation (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 1: Suicidality (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 1: Suicidal behaviour (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 1: Suicidal ideation (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 2: Suicidality (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 2: Suicidal behaviour (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 2: Suicidal ideation (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 8: Suicidality (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 8: Suicidal behaviour (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 8: Suicidal ideation (n=16,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 18: Suicidal behaviour (n=16,14)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Week 18: Suicidal ideation (n=16,14)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Last visit: Suicidality (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Last visit: Suicidal behaviour (n=17,18)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Last visit: Suicidal ideation (n=17,18)
|
0 Participants
|
0 Participants
|
Adverse Events
Aripiprazole IM Depot 400 mg: Deltoid
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Aripiprazole IM Depot 400 mg: Gluteal
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole IM Depot 400 mg: Deltoid
n=17 participants at risk
The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
|
Aripiprazole IM Depot 400 mg: Gluteal
n=18 participants at risk
The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
2/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Gingival pain
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
11.8%
2/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Axillary pain
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Chills
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Injection site pain
|
35.3%
6/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
27.8%
5/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Injection site rash
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
General disorders
Pain
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Infections and infestations
Furuncle
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Infections and infestations
Infected bites
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
11.8%
2/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Investigations
Blood triglycerides increased
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Investigations
Electrocardiogram T wave inversion
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Investigations
Glucose urine present
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.6%
3/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Akathisia
|
17.6%
3/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
16.7%
3/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
16.7%
3/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Dyskinesia
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Dystonia
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
22.2%
4/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Sedation
|
5.9%
1/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
11.1%
2/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
17.6%
3/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
0.00%
0/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
5.6%
1/18 • Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee There is no agreement between PI and sponsor that restricts the PI's right to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER