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Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00882362
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: OPC-14597 (Aripiprazole)
Enrollment 155
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuing Subjects Newly Entering Subjects
Hide Arm/Group Description Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study Newly entering elderly patients with major depressive disorder, aged 65 and above
Period Title: Overall Study
Started 122 33
Completed 73 10
Not Completed 49 23
Reason Not Completed
Adverse Event             13             10
Withdrawal by Subject             13             10
Lack of Efficacy             3             0
Protocol Violation             7             2
Pregnancy             1             0
Physician Decision             5             1
Diabetic glucose level or HbA1C>=6.5%             2             0
change of residence or other commitments             5             0
Arm/Group Title Continuing Subjects Newly Entering Subjects Total
Hide Arm/Group Description Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study Newly entering elderly patients with major depressive disorder, aged 65 and above Total of all reporting groups
Overall Number of Baseline Participants 122 33 155
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 33 participants 155 participants
39.1  (8.6) 73.1  (5.6) 46.3  (16.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 33 participants 155 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
122
 100.0%
0
   0.0%
122
  78.7%
>=65 years
0
   0.0%
33
 100.0%
33
  21.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 33 participants 155 participants
Female
55
  45.1%
23
  69.7%
78
  50.3%
Male
67
  54.9%
10
  30.3%
77
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 122 participants 33 participants 155 participants
122 33 155
1.Primary Outcome
Title Montgomery–Asberg Depression Rating Scale (MADRS)
Hide Description

Change from baseline to Last Observation Carried Forward (LOCF).

Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

The questionnaire includes questions on the following symptoms

1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts

Time Frame Baseline(Day 1), Week52 or at discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuing Subjects Newly Entering Subjects
Hide Arm/Group Description:
Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
Newly entering elderly patients with major depressive disorder, aged 65 and above
Overall Number of Participants Analyzed 122 33
Mean (Standard Error)
Unit of Measure: Rating Score
-4.60  (0.8) -10.5  (1.9)
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuing Subjects Newly Entering Subjects
Hide Arm/Group Description Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study Newly entering elderly patients with major depressive disorder, aged 65 and above
All-Cause Mortality
Continuing Subjects Newly Entering Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Continuing Subjects Newly Entering Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/122 (1.64%)      4/33 (12.12%)    
Gastrointestinal disorders     
Gastrointestinal Haemorrhage * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Infections and infestations     
Pneumonia * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Urinary Tract Infection * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Injury, poisoning and procedural complications     
Femur Fracture * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Haematoma Subdural * 1  1/122 (0.82%)  1 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Nervous system disorders     
Parkinsonism * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion Missed * 1  1/122 (0.82%)  1 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Interstitial Lung Disease * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
Pneumothorax * 1  0/122 (0.00%)  0 1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MesDRA (14.1)J
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Continuing Subjects Newly Entering Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   111/122 (90.98%)      29/33 (87.88%)    
Gastrointestinal disorders     
Constipation * 1  7/122 (5.74%)  9 6/33 (18.18%)  6
Diarrhoea * 1  9/122 (7.38%)  13 2/33 (6.06%)  2
Stomatitis * 1  1/122 (0.82%)  1 2/33 (6.06%)  2
Salivary Hypersecretion * 1  2/122 (1.64%)  2 2/33 (6.06%)  3
Nausea * 1  7/122 (5.74%)  8 1/33 (3.03%)  1
General disorders     
Oedema * 1  1/122 (0.82%)  1 2/33 (6.06%)  2
Malaise * 1  6/122 (4.92%)  6 2/33 (6.06%)  3
Infections and infestations     
Nasopharyngitis * 1  42/122 (34.43%)  62 5/33 (15.15%)  7
Injury, poisoning and procedural complications     
Contusion * 1  3/122 (2.46%)  4 4/33 (12.12%)  7
Fall * 1  0/122 (0.00%)  0 4/33 (12.12%)  6
Investigations     
Weight Increased * 1  39/122 (31.97%)  39 2/33 (6.06%)  2
Blood Triglycerides Increased * 1  11/122 (9.02%)  13 1/33 (3.03%)  2
Alanine Aminotransferase Increased * 1  9/122 (7.38%)  9 0/33 (0.00%)  0
Blood Alkaline Phosphatase Increased * 1  2/122 (1.64%)  2 2/33 (6.06%)  2
Blood Creatine Phosphokinase Increased * 1  3/122 (2.46%)  3 2/33 (6.06%)  2
Weight Decreased * 1  3/122 (2.46%)  3 2/33 (6.06%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/122 (0.82%)  1 2/33 (6.06%)  2
Nervous system disorders     
Akathisia * 1  34/122 (27.87%)  39 8/33 (24.24%)  10
Somnolence * 1  14/122 (11.48%)  15 5/33 (15.15%)  5
Tremor * 1  12/122 (9.84%)  14 2/33 (6.06%)  2
Dysgeusia * 1  1/122 (0.82%)  1 3/33 (9.09%)  3
Dizziness Postural * 1  2/122 (1.64%)  2 2/33 (6.06%)  2
Headache * 1  6/122 (4.92%)  6 2/33 (6.06%)  3
Dyskinesia * 1  7/122 (5.74%)  7 2/33 (6.06%)  2
Psychiatric disorders     
Insomnia * 1  6/122 (4.92%)  6 4/33 (12.12%)  4
Major Depression * 1  9/122 (7.38%)  10 1/33 (3.03%)  1
Renal and urinary disorders     
Urinary Incontinence * 1  0/122 (0.00%)  0 2/33 (6.06%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MesDRA (14.1)J
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
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00882362     History of Changes
Other Study ID Numbers: 031-08-002
JapinCTI-090725
First Submitted: April 2, 2009
First Posted: April 16, 2009
Results First Submitted: December 20, 2013
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014