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An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01646827
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : July 31, 2014
Last Update Posted : July 31, 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: Basic Science
Condition: Schizophrenia
Intervention: Drug: Aripiprazole IM Depot

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This report presents results of a study on 37 adults with schizophrenia, conducted at 6 centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Aripiprazole IM Depot 400 mg: Deltoid   Aripiprazole IM Depot 400 mg: Gluteal
STARTED   18   19 
COMPLETED   16   14 
NOT COMPLETED   2   5 
Lost to Follow-up                0                3 
Physician Decision                1                2 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Aripiprazole IM Depot 400 mg: Deltoid   Aripiprazole IM Depot 400 mg: Gluteal   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.1  (11.0)   45.9  (7.3)   44.5  (9.3) 
Gender 
[Units: Participants]
     
Female   6   4   10 
Male   12   15   27 


  Outcome Measures

1.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Aripriprazole   [ Time Frame: 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 ]

2.  Primary:   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   [ Time Frame: 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 ]

3.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole   [ Time Frame: 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 ]

4.  Primary:   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   [ Time Frame: 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 ]

5.  Secondary:   Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).   [ Time Frame: Starting at the time the ICF was signed to Day 126/Early termination ]

6.  Secondary:   Number of Participants With Laboratory Values of Potential Clinical Relevance.   [ Time Frame: Day 1, Day 28, Day 126/Early termination ]

7.  Secondary:   Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure   [ Time Frame: Day 1, Day 14, Day 28 and Day 126/Early termination ]

8.  Secondary:   Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature   [ Time Frame: Day 1, Day 14, Day 28 and Day 126/Early termination ]

9.  Secondary:   Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate   [ Time Frame: Day 1, Day 14, Day 28 and Day 126/Early termination ]

10.  Secondary:   Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance   [ Time Frame: Day 1, Day 14, Day 28 and Day 126/Early termination ]

11.  Secondary:   Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.   [ Time Frame: Day 1, Day 14, Day 28 and last visit ]

12.  Secondary:   Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.   [ Time Frame: Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
phone: 800 562-3974


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01646827     History of Changes
Other Study ID Numbers: 31-11-290
First Submitted: June 18, 2012
First Posted: July 20, 2012
Results First Submitted: April 30, 2014
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014