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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090724 |
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To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fixed dose |
|
| 2 | Experimental | Titration dose |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole (Fixed dose) | Drug | administered orally once daily, 3 mg daily, 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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 | Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Response Rate | 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). | Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
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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 | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24965202 | Derived | Ozaki N, Otsubo T, Kato M, Higuchi T, Ono H, Kamijima K; ADMIRE Study Group. Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: a subgroup analysis and Montgomery-Asberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study. Psychiatry Clin Neurosci. 2015 Jan;69(1):34-42. doi: 10.1111/pcn.12214. Epub 2014 Aug 4. | |
| 24074484 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Variable Dose Group of Aripiprazole | 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 |
| FG001 | Fixed Dose Group of Aripiprazole | Aripiprazole 3 mg were administered orally once daily |
| FG002 | Placebo Group | Placebo were administered orally once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Variable Dose Group of Aripiprazole | 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 |
| BG001 | Fixed Dose Group of Aripiprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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 | Posted | Mean | Standard Error | Rating score | Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
|
6 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 | Variable Dose Group of Aripiprazole | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA(14.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ld. | +81-3-6361-7366 |
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| 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 |
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| Aripiprazole (Titrated dose) | Drug | administered orally once daily, 3 to 15 mg daily, 6 weeks |
|
|
| Placebo | Drug | administered orally once daily, 6 weeks |
|
|
| Mean Change in Sheehan Disability Scale (SDISS) |
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). |
| Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Derived |
| Kamijima K, Higuchi T, Ishigooka J, Ohmori T, Ozaki N, Kanba S, Kinoshita T, Koyama T; ADMIRE Study Group. Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder: a randomized, double-blind, placebo-controlled study (ADMIRE study). J Affect Disord. 2013 Dec;151(3):899-905. doi: 10.1016/j.jad.2013.07.035. Epub 2013 Aug 28. |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Physician Decision |
|
| Diabetic glucose level or HbA1C>=6.5% |
|
| Change of residence or other commitments |
|
Aripiprazole 3 mg were administered orally once daily |
| BG002 | Placebo Group | Placebo were administered orally once daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
| OG001 | Fixed Dose Group of Aripiprazole | Aripiprazole 3 mg were administered orally once daily |
| OG002 | Placebo Group | Placebo were administered orally once daily |
|
|
|
| Secondary | MADRS Response Rate | 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). | Posted | Number | percentage of subjects | Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
|
|
|
| Secondary | Mean Change in Sheehan Disability Scale (SDISS) | 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). | Posted | Mean | Standard Error | Rating score | Baseline (the end of the SSRI/SNRI treatment period), at completion of administration |
|
|
|
| 3 |
| 194 |
| 140 |
| 194 |
| EG001 | Fixed Dose Group of Aripiprazole | Aripiprazole 3 mg were administered orally once daily | 2 | 197 | 122 | 197 |
| EG002 | Placebo Group | Placebo were administered orally once daily | 2 | 195 | 92 | 195 |
| Head Injury | Injury, poisoning and procedural complications | MedDRA(14.1)J | Non-systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA(14.1)J | Non-systematic Assessment |
|
| Post-Traumatic Neck Syndrome | Injury, poisoning and procedural complications | MedDRA(14.1)J | Non-systematic Assessment |
|
| Traffic Accident | Injury, poisoning and procedural complications | MedDRA(14.1)J | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(14.1)J | Non-systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Haemorrhage Subcutaneous | Skin and subcutaneous tissue disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA(14.1)J | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
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| Blood Triglycerides Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
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| Gamma-Glutamyltransferase Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA(14.1)J | Non-systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA(14.1)J | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
| Terminal Insomnia | Psychiatric disorders | MedDRA(14.1)J | Non-systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |