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A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

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ClinicalTrials.gov Identifier: NCT00606320
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar I Disorder
Intervention Drug: Aripiprazole
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazple
Hide Arm/Group Description

Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.

Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days.

Period Title: Overall Study
Started 59
Completed 22
Not Completed 37
Reason Not Completed
Adverse Event             3
Lack of Efficacy             5
Physician Decision             7
Protocol Violation             8
Withdrawal by Subject             10
Progression to depressive phase             4
Arm/Group Title Arupiprazole
Hide Arm/Group Description

Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.

Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days.

Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
Full Analysis Population(FAS):Excluding the following subjects from the randomized subjects: 3 subjects with GCP violation 1 subject whose post dose efficacy were not available
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
34.5  (12.45)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
3
   5.5%
Between 18 and 65 years
52
  94.5%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
28
  50.9%
Male
27
  49.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants
Taiwan 5
China 17
Japan 11
Malaysia 6
Indonesia 4
Philippines 12
1.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.
Time Frame baseline (Day 1 of preceding study), Day 154 or at discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazple
Hide Arm/Group Description:

Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.

Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days.

Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-18.3  (12.71)
2.Secondary Outcome
Title Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
Hide Description

CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).

Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.

Time Frame Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazple
Hide Arm/Group Description:

Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.

Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days.

Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.4  (1.76)
Time Frame 22 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%) # Events
Total   2/56 (3.57%)    
Hepatobiliary disorders   
Hepatitis * 1  1/56 (1.79%)  1
Nervous system disorders   
Headache * 1  1/56 (1.79%)  1
Psychiatric disorders   
Mania * 1  1/56 (1.79%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole
Affected / at Risk (%) # Events
Total   37/56 (66.07%)    
Gastrointestinal disorders   
Constipation * 1  4/56 (7.14%)  8
Salivary Hypersecretion * 1  4/56 (7.14%)  4
Vomiting * 1  4/56 (7.14%)  6
Nausea * 1  3/56 (5.36%)  4
Diarrhoea * 1  3/56 (5.36%)  4
General disorders   
Fatigue * 1  3/56 (5.36%)  3
Infections and infestations   
Nasopharyngitis * 1  5/56 (8.93%)  5
Investigations   
Weight Increased * 1  16/56 (28.57%)  16
Alanine Aminotransferase Increased * 1  4/56 (7.14%)  4
Blood Creatine Phosphokinase Increased * 1  3/56 (5.36%)  3
Musculoskeletal and connective tissue disorders   
Muscle Rigidity * 1  4/56 (7.14%)  4
Nervous system disorders   
Akathisia * 1  12/56 (21.43%)  13
Tremor * 1  10/56 (17.86%)  14
Somnolence * 1  8/56 (14.29%)  8
Headache * 1  5/56 (8.93%)  6
Dystonia * 1  3/56 (5.36%)  3
Psychiatric disorders   
Insomnia * 1  8/56 (14.29%)  12
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(12.1)
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: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co, Ltd.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00606320     History of Changes
Other Study ID Numbers: 031-06-005
First Submitted: January 19, 2008
First Posted: February 1, 2008
Results First Submitted: November 28, 2013
Results First Posted: February 12, 2014
Last Update Posted: February 12, 2014