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Trial record 52 of 1900 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND major

Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00876343
Recruitment Status : Completed
First Posted : April 6, 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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Aripiprazole (Fixed dose)
Drug: Aripiprazole (Titrated dose)
Drug: Placebo
Enrollment 586
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Hide Arm/Group Description Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out Aripiprazole 3 mg were administered orally once daily Placebo were administered orally once daily
Period Title: Overall Study
Started 194 197 195
Completed 177 180 183
Not Completed 17 17 12
Reason Not Completed
Adverse Event             7             8             2
Withdrawal by Subject             4             4             3
Lack of Efficacy             0             0             1
Protocol Violation             4             1             1
Physician Decision             0             1             1
Diabetic glucose level or HbA1C>=6.5%             0             1             1
Change of residence or other commitments             2             2             3
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group Total
Hide Arm/Group Description Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out Aripiprazole 3 mg were administered orally once daily Placebo were administered orally once daily Total of all reporting groups
Overall Number of Baseline Participants 194 197 195 586
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 197 participants 195 participants 586 participants
38.1  (9.6) 39.2  (9.1) 38.7  (9.2) 38.7  (9.3)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 197 participants 195 participants 586 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
194
 100.0%
197
 100.0%
195
 100.0%
586
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 197 participants 195 participants 586 participants
Female
93
  47.9%
73
  37.1%
80
  41.0%
246
  42.0%
Male
101
  52.1%
124
  62.9%
115
  59.0%
340
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 194 participants 197 participants 195 participants 586 participants
194 197 195 586
1.Primary Outcome
Title Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description

The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.

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 (the end of the SSRI/SNRI treatment period), at completion of administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Hide Arm/Group Description:
Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
Aripiprazole 3 mg were administered orally once daily
Placebo were administered orally once daily
Overall Number of Participants Analyzed 194 197 195
Mean (Standard Error)
Unit of Measure: Rating score
-9.6  (0.6) -10.5  (0.6) -7.4  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Variable Dose Group of Aripiprazole, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.7 to -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fixed Dose Group of Aripiprazole, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-4.6 to -1.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title MADRS Response Rate
Hide Description The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).
Time Frame Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Hide Arm/Group Description:
Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
Aripiprazole 3 mg were administered orally once daily
Placebo were administered orally once daily
Overall Number of Participants Analyzed 194 197 195
Measure Type: Number
Unit of Measure: percentage of subjects
39.2 42.1 28.2
3.Secondary Outcome
Title Mean Change in Sheehan Disability Scale (SDISS)
Hide Description

The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.

The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

Time Frame Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Hide Arm/Group Description:
Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
Aripiprazole 3 mg were administered orally once daily
Placebo were administered orally once daily
Overall Number of Participants Analyzed 194 197 195
Mean (Standard Error)
Unit of Measure: Rating score
-1.03  (0.11) -0.96  (0.11) -0.46  (0.11)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Hide Arm/Group Description Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out Aripiprazole 3 mg were administered orally once daily Placebo were administered orally once daily
All-Cause Mortality
Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/194 (1.55%)      2/197 (1.02%)      2/195 (1.03%)    
Injury, poisoning and procedural complications       
Contusion * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  4
Head Injury * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  1
Ligament Sprain * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  1
Post-Traumatic Neck Syndrome * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  1
Traffic Accident * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  1
Musculoskeletal and connective tissue disorders       
Back Pain * 1  0/194 (0.00%)  0 1/197 (0.51%)  1 0/195 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant Melanoma * 1  1/194 (0.52%)  1 0/197 (0.00%)  0 0/195 (0.00%)  0
Psychiatric disorders       
Delusion * 1  0/194 (0.00%)  0 1/197 (0.51%)  1 0/195 (0.00%)  0
Hallucination * 1  0/194 (0.00%)  0 1/197 (0.51%)  1 0/195 (0.00%)  0
Major Depression * 1  1/194 (0.52%)  1 0/197 (0.00%)  0 0/195 (0.00%)  0
Suicide Attempt * 1  1/194 (0.52%)  1 1/197 (0.51%)  1 1/195 (0.51%)  1
Skin and subcutaneous tissue disorders       
Haemorrhage Subcutaneous * 1  0/194 (0.00%)  0 0/197 (0.00%)  0 1/195 (0.51%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(14.1)J
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Variable Dose Group of Aripiprazole Fixed Dose Group of Aripiprazole Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   140/194 (72.16%)      122/197 (61.93%)      92/195 (47.18%)    
Gastrointestinal disorders       
Abdominal Discomfort * 1  1/194 (0.52%)  1 5/197 (2.54%)  5 2/195 (1.03%)  2
Abdominal Pain Upper * 1  4/194 (2.06%)  4 1/197 (0.51%)  1 2/195 (1.03%)  2
Constipation * 1  15/194 (7.73%)  15 7/197 (3.55%)  7 4/195 (2.05%)  4
Diarrhoea * 1  5/194 (2.58%)  5 6/197 (3.05%)  6 10/195 (5.13%)  10
Nausea * 1  6/194 (3.09%)  6 9/197 (4.57%)  10 10/195 (5.13%)  10
Salivary Hypersecretion * 1  8/194 (4.12%)  8 2/197 (1.02%)  3 0/195 (0.00%)  0
Vomiting * 1  1/194 (0.52%)  1 5/197 (2.54%)  6 3/195 (1.54%)  3
General disorders       
Malaise * 1  10/194 (5.15%)  10 2/197 (1.02%)  2 8/195 (4.10%)  8
Oedema Peripheral * 1  4/194 (2.06%)  4 1/197 (0.51%)  1 0/195 (0.00%)  0
Pyrexia * 1  4/194 (2.06%)  5 1/197 (0.51%)  1 0/195 (0.00%)  0
Thirst * 1  13/194 (6.70%)  13 10/197 (5.08%)  10 3/195 (1.54%)  3
Infections and infestations       
Nasopharyngitis * 1  31/194 (15.98%)  32 30/197 (15.23%)  31 28/195 (14.36%)  31
Investigations       
Alanine Aminotransferase Increased * 1  13/194 (6.70%)  13 14/197 (7.11%)  14 3/195 (1.54%)  3
Aspartate Aminotransferase Increased * 1  8/194 (4.12%)  8 10/197 (5.08%)  10 1/195 (0.51%)  1
Blood Alkaline Phosphatase Increased * 1  4/194 (2.06%)  4 2/197 (1.02%)  2 0/195 (0.00%)  0
Blood Creatine Phosphokinase Increased * 1  6/194 (3.09%)  6 10/197 (5.08%)  10 0/195 (0.00%)  0
Blood Pressure Increased * 1  3/194 (1.55%)  3 5/197 (2.54%)  5 3/195 (1.54%)  3
Blood Triglycerides Increased * 1  8/194 (4.12%)  9 4/197 (2.03%)  4 2/195 (1.03%)  2
Gamma-Glutamyltransferase Increased * 1  5/194 (2.58%)  5 6/197 (3.05%)  6 1/195 (0.51%)  1
Weight Increased * 1  12/194 (6.19%)  12 8/197 (4.06%)  8 1/195 (0.51%)  1
Metabolism and nutrition disorders       
Increased Appetite * 1  6/194 (3.09%)  6 2/197 (1.02%)  2 3/195 (1.54%)  3
Musculoskeletal and connective tissue disorders       
Muscle Rigidity * 1  2/194 (1.03%)  2 5/197 (2.54%)  5 4/195 (2.05%)  4
Nervous system disorders       
Akathisia * 1  71/194 (36.60%)  73 28/197 (14.21%)  30 8/195 (4.10%)  8
Dizziness * 1  2/194 (1.03%)  2 5/197 (2.54%)  5 6/195 (3.08%)  6
Dyskinesia * 1  2/194 (1.03%)  2 5/197 (2.54%)  6 1/195 (0.51%)  1
Dystonia * 1  6/194 (3.09%)  6 4/197 (2.03%)  4 0/195 (0.00%)  0
Headache * 1  4/194 (2.06%)  6 9/197 (4.57%)  9 15/195 (7.69%)  16
Hypoaesthesia * 1  1/194 (0.52%)  1 4/197 (2.03%)  4 0/195 (0.00%)  0
Parkinsonism * 1  4/194 (2.06%)  4 0/197 (0.00%)  0 0/195 (0.00%)  0
Somnolence * 1  15/194 (7.73%)  15 19/197 (9.64%)  19 13/195 (6.67%)  14
Tremor * 1  20/194 (10.31%)  23 14/197 (7.11%)  16 5/195 (2.56%)  5
Psychiatric disorders       
Insomnia * 1  10/194 (5.15%)  10 8/197 (4.06%)  8 3/195 (1.54%)  3
Terminal Insomnia * 1  5/194 (2.58%)  5 0/197 (0.00%)  0 0/195 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA(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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ld.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00876343     History of Changes
Other Study ID Numbers: 031-08-001
JapicCTI-090724
First Submitted: April 2, 2009
First Posted: April 6, 2009
Results First Submitted: December 20, 2013
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014