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Trial record 21 of 408 for:    ARIPIPRAZOLE

A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870999
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: aripiprazole IM depot
Drug: aripiprazole tablets
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Period Title: Overall Study
Started 14 16 11
Safety Population; Received Study Drug 14 15 10
Completed 10 8 4
Not Completed 4 8 7
Reason Not Completed
Adverse Event             0             4             1
Subject met withdrawal criteria             3             2             0
Subject withdrawn by Investigator             1             0             0
Withdrawal by Subject             0             2             5
Protocol Violation             0             0             1
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot Total
Hide Arm/Group Description 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. Total of all reporting groups
Overall Number of Baseline Participants 14 16 11 41
Hide Baseline Analysis Population Description
All participants randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 11 participants 41 participants
46.8  (9.2) 43.3  (9.6) 46.0  (12.7) 45.2  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 11 participants 41 participants
Female
7
  50.0%
4
  25.0%
1
   9.1%
12
  29.3%
Male
7
  50.0%
12
  75.0%
10
  90.9%
29
  70.7%
1.Primary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety
Hide Description Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.
Time Frame 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication are included in the safety analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 14 15 10
Measure Type: Number
Unit of Measure: Participants
11 11 6
2.Primary Outcome
Title Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
316  (160) 269  (128) 100  (68.4)
3.Primary Outcome
Title Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.
Time Frame 672 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
212  (113) 156  (67.7) 95.0  (86.2)
4.Primary Outcome
Title Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 7 4
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
163  (88.8) 140  (58.4) 54.5  (39.4)
5.Secondary Outcome
Title Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Median (Full Range)
Unit of Measure: Day
7.1
(3.0 to 11.2)
6.5
(0.5 to 21.2)
5.0
(4.0 to 27.9)
6.Secondary Outcome
Title Aripiprazole Steady-state Plasma Concentration (Css,Avg)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 7 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
242  (132) 208  (87.0) 81.1  (58.7)
7.Secondary Outcome
Title Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 6 4 0
Mean (Standard Deviation)
Unit of Measure: Day
46.5  (10.8) 29.9  (8.0)
8.Secondary Outcome
Title Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
89.4  (37.9) 74.7  (20.8) 30.3  (19.8)
9.Secondary Outcome
Title Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
64.1  (27.0) 54.1  (21.1) 26.2  (24.7)
10.Secondary Outcome
Title Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
47.8  (19.1) 38.9  (13.2) 14.7  (9.47)
11.Secondary Outcome
Title Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Hide Description Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Time Frame Pre-dose and 1 to 1344 hours post-dose at Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 10 8 4
Median (Full Range)
Unit of Measure: Day
6.6
(3.0 to 14.0)
12.5
(0.5 to 22.2)
5.5
(0.0 to 27.9)
12.Secondary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
Hide Description The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 13 14 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 0.0  (20.2) 1.1  (12.1) -1.3  (4.8)
Week 24 -0.8  (20.9) -1.6  (14.1) -1.3  (5.3)
13.Secondary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
Hide Description The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available were included in this analysis population (LOCF).
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 13 14 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 -1.2  (6.1) 1.3  (4.0) -1.0  (1.2)
Week 24 -1.6  (6.1) 0.4  (4.5) -1.0  (1.6)
14.Secondary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
Hide Description The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available were included in this analysis population (LOCF).
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 13 14 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 1.1  (4.4) 0.1  (3.2) 0.0  (2.0)
Week 24 0.5  (4.2) -0.1  (3.7) -0.6  (2.0)
15.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
Hide Description The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available were included in this analysis population (LOCF).
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 14 16 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 -0.1  (0.5) 0.0  (0.6) -0.2  (0.4)
Week 24 -0.1  (0.5) -0.1  (0.7) -0.2  (0.4)
16.Secondary Outcome
Title Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
Hide Description The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available at the given time-point were included in this analysis population.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 13 15 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 (n=12, 13, 9) 3.3  (0.9) 3.6  (0.8) 3.4  (0.7)
Week 24 3.7  (1.0) 3.4  (0.7) 3.7  (0.7)
17.Secondary Outcome
Title Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia"
Hide Description The number of participants hospitalized for the Adverse Event “Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.
Time Frame 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the analysis population.
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description:
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Overall Number of Participants Analyzed 14 16 11
Measure Type: Number
Unit of Measure: Participants
0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population included all randomized participants who received study drug.
 
Arm/Group Title 400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Hide Arm/Group Description 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
All-Cause Mortality
400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   3/15 (20.00%)   0/10 (0.00%) 
General disorders       
Chest Pain  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Metabolism and nutrition disorders       
Diabetic ketoacidosis  2  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Psychiatric disorders       
Psychotic disorder  2  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Schizophrenia  2  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
2
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 mg Aripiprazole IM Depot 300 mg Aripiprazole IM Depot 200 mg Aripiprazole IM Depot
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   10/15 (66.67%)   6/10 (60.00%) 
Cardiac disorders       
Tachycardia  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Gastrointestinal disorders       
Constipation  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Dry Mouth  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Dyspepsia  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Nausea  1  0/14 (0.00%)  2/15 (13.33%)  0/10 (0.00%) 
Salivary hypersecretion  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Toothache  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Vomiting  1  2/14 (14.29%)  2/15 (13.33%)  0/10 (0.00%) 
General disorders       
Cyst  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Fatigue  1  0/14 (0.00%)  1/15 (6.67%)  1/10 (10.00%) 
Injection site discomfort  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Injection site pain  1  4/14 (28.57%)  0/15 (0.00%)  0/10 (0.00%) 
Pyrexia  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Infections and infestations       
Bed bug infestation  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Furuncle  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Gastroenteritis viral  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Infected insect bite  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Influenza  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Nasopharyngitis  1  2/14 (14.29%)  1/15 (6.67%)  0/10 (0.00%) 
Sinusitis  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Upper respiratory tract infection  1  2/14 (14.29%)  1/15 (6.67%)  1/10 (10.00%) 
Vaginal infection  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Muscle strain  1  2/14 (14.29%)  0/15 (0.00%)  0/10 (0.00%) 
Procedural pain  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Investigations       
Blood glucose increased  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Blood magnesium increased  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Blood potassium decreased  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Cardiac murmur  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Electrocardiogram QT corrected interval prolonged  1  0/14 (0.00%)  2/15 (13.33%)  1/10 (10.00%) 
Glucose urine present  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Hyperglycaemia  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Increased appetite  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Back pain  1  1/14 (7.14%)  1/15 (6.67%)  0/10 (0.00%) 
Musculoskeletal stiffness  1  2/14 (14.29%)  0/15 (0.00%)  0/10 (0.00%) 
Myalgia  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Nervous system disorders       
Akathisia  1  1/14 (7.14%)  1/15 (6.67%)  1/10 (10.00%) 
Disturbance in attention  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Dizziness  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Dyskinesia  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Dystonia  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Headache  1  1/14 (7.14%)  0/15 (0.00%)  2/10 (20.00%) 
Sedation  1  2/14 (14.29%)  0/15 (0.00%)  0/10 (0.00%) 
Somnolence  1  0/14 (0.00%)  2/15 (13.33%)  1/10 (10.00%) 
Tremor  1  3/14 (21.43%)  1/15 (6.67%)  0/10 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/14 (7.14%)  1/15 (6.67%)  0/10 (0.00%) 
Drug dependence  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Hallucination, auditory  1  1/14 (7.14%)  1/15 (6.67%)  0/10 (0.00%) 
Hallucination, visual  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Insomnia  1  1/14 (7.14%)  1/15 (6.67%)  1/10 (10.00%) 
Nightmare  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Paranoia  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Restlessness  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Psychotic disorder  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Erectile dysfunction  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/14 (7.14%)  0/15 (0.00%)  1/10 (10.00%) 
Pharyngolaryngeal pain  1  1/14 (7.14%)  0/15 (0.00%)  0/10 (0.00%) 
Wheezing  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  2/14 (14.29%)  0/15 (0.00%)  0/10 (0.00%) 
Vascular disorders       
Hypertension  1  0/14 (0.00%)  1/15 (6.67%)  0/10 (0.00%) 
Orthostatic hypotension  1  0/14 (0.00%)  0/15 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 800-562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01870999     History of Changes
Other Study ID Numbers: 31-05-244
First Submitted: June 4, 2013
First Posted: June 6, 2013
Results First Submitted: August 12, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014