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| ID | Type | Description | Link |
|---|---|---|---|
| JapinCTI-090725 |
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To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-14597 (Aripiprazole) | Drug | administered orally once daily, 3 to 15 mg daily, 52 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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 | Baseline(Day 1), Week52 or at discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | OPC-J | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Newly Entering Subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
Newly entering elderly patients with major depressive disorder, aged 65 and above
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Newly Entering Subjects | Newly entering elderly patients with major depressive disorder, aged 65 and above |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | 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 | Posted | Mean | Standard Error | Rating Score | Baseline(Day 1), Week52 or at discontinuation |
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52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 122 | 111 | 122 | ||
| EG001 | Newly Entering Subjects | Newly entering elderly patients with major depressive disorder, aged 65 and above | 4 | 33 | 29 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MesDRA (14.1)J | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MesDRA (14.1)J | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MesDRA (14.1)J | Non-systematic Assessment |
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| Haematoma Subdural | Injury, poisoning and procedural complications | MesDRA (14.1)J | Non-systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MesDRA (14.1)J | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Abortion Missed | Pregnancy, puerperium and perinatal conditions | MesDRA (14.1)J | Non-systematic Assessment |
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| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Salivary Hypersecretion | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Oedema | General disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Malaise | General disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MesDRA (14.1)J | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MesDRA (14.1)J | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MesDRA (14.1)J | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Dizziness Postural | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Headache | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | MesDRA (14.1)J | Non-systematic Assessment |
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| Weight Increased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Blood Triglycerides Increased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Weight Decreased | Investigations | MesDRA (14.1)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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