Trial Outcomes & Findings for Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder (NCT NCT00882362)
NCT ID: NCT00882362
Last Updated: 2014-02-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
155 participants
Primary outcome timeframe
Baseline(Day 1), Week52 or at discontinuation
Results posted on
2014-02-10
Participant Flow
Participant milestones
| Measure |
Continuing Subjects
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 Subjects
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
33
|
|
Overall Study
COMPLETED
|
73
|
10
|
|
Overall Study
NOT COMPLETED
|
49
|
23
|
Reasons for withdrawal
| Measure |
Continuing Subjects
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 Subjects
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Protocol Violation
|
7
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Diabetic glucose level or HbA1C>=6.5%
|
2
|
0
|
|
Overall Study
change of residence or other commitments
|
5
|
0
|
Baseline Characteristics
Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Continuing Subjects
n=122 Participants
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 Subjects
n=33 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
122 participants
n=5 Participants
|
33 participants
n=7 Participants
|
155 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline(Day 1), Week52 or at discontinuationChange 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
Outcome measures
| Measure |
Continuing Subjects
n=122 Participants
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 Subjects
n=33 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
-4.60 Rating Score
Standard Error 0.8
|
-10.5 Rating Score
Standard Error 1.9
|
Adverse Events
Continuing Subjects
Serious events: 2 serious events
Other events: 111 other events
Deaths: 0 deaths
Newly Entering Subjects
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuing Subjects
n=122 participants at risk
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 Subjects
n=33 participants at risk
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Haematoma Subdural
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
0.00%
0/33 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
0.00%
0/33 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/122 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Continuing Subjects
n=122 participants at risk
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 Subjects
n=33 participants at risk
Newly entering elderly patients with major depressive disorder, aged 65 and above
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.7%
7/122 • Number of events 9 • 52 weeks
|
18.2%
6/33 • Number of events 6 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
9/122 • Number of events 13 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
1.6%
2/122 • Number of events 2 • 52 weeks
|
6.1%
2/33 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.7%
7/122 • Number of events 8 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
General disorders
Oedema
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
General disorders
Malaise
|
4.9%
6/122 • Number of events 6 • 52 weeks
|
6.1%
2/33 • Number of events 3 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
34.4%
42/122 • Number of events 62 • 52 weeks
|
15.2%
5/33 • Number of events 7 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
3/122 • Number of events 4 • 52 weeks
|
12.1%
4/33 • Number of events 7 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/122 • 52 weeks
|
12.1%
4/33 • Number of events 6 • 52 weeks
|
|
Nervous system disorders
Akathisia
|
27.9%
34/122 • Number of events 39 • 52 weeks
|
24.2%
8/33 • Number of events 10 • 52 weeks
|
|
Nervous system disorders
Somnolence
|
11.5%
14/122 • Number of events 15 • 52 weeks
|
15.2%
5/33 • Number of events 5 • 52 weeks
|
|
Nervous system disorders
Tremor
|
9.8%
12/122 • Number of events 14 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.82%
1/122 • Number of events 1 • 52 weeks
|
9.1%
3/33 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Dizziness Postural
|
1.6%
2/122 • Number of events 2 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Nervous system disorders
Headache
|
4.9%
6/122 • Number of events 6 • 52 weeks
|
6.1%
2/33 • Number of events 3 • 52 weeks
|
|
Nervous system disorders
Dyskinesia
|
5.7%
7/122 • Number of events 7 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/122 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
4.9%
6/122 • Number of events 6 • 52 weeks
|
12.1%
4/33 • Number of events 4 • 52 weeks
|
|
Psychiatric disorders
Major Depression
|
7.4%
9/122 • Number of events 10 • 52 weeks
|
3.0%
1/33 • Number of events 1 • 52 weeks
|
|
Investigations
Weight Increased
|
32.0%
39/122 • Number of events 39 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Investigations
Blood Triglycerides Increased
|
9.0%
11/122 • Number of events 13 • 52 weeks
|
3.0%
1/33 • Number of events 2 • 52 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
7.4%
9/122 • Number of events 9 • 52 weeks
|
0.00%
0/33 • 52 weeks
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
1.6%
2/122 • Number of events 2 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.5%
3/122 • Number of events 3 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
|
Investigations
Weight Decreased
|
2.5%
3/122 • Number of events 3 • 52 weeks
|
6.1%
2/33 • Number of events 2 • 52 weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place