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This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F | Experimental |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvoxamine maleate | Drug | Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica |
| Measure | Description | Time Frame |
|---|---|---|
| the time of onset of 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Global Impression(CGI) improvement at Week 8 | 8 weeks |
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Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate
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| Name | Affiliation | Role |
|---|---|---|
| Toshiaki Yamaguchi | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S114.3.117 Kohnodai Hospital, National Center of N | Chiba Prefecture | Japan | ||||
| S114.3.117 Fukuoka University Hospital |
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|
| Placebo | Drug | Placebo |
|
| Fukuoka Prefecture |
| Japan |
| S114.3.117 Hatakeyama Clinic | Fukuoka Prefecture | Japan |
| S114.3.117 Kaname Clinic | Fukuoka Prefecture | Japan |
| S114.3.117 Kashi shinryo Clinic | Fukuoka Prefecture | Japan |
| S114.3.117 Kashii Sanatorium | Fukuoka Prefecture | Japan |
| S114.3.117 Kyushu University Hospital | Fukuoka Prefecture | Japan |
| S114.3.117 Shiranui Hospital | Fukuoka Prefecture | Japan |
| S114.3.117 Sugahara Tenjin Hospital | Fukuoka Prefecture | Japan |
| S114.3.117 Hiroshima-city Funairi Hospital | Hiroshima Prefecture | Japan |
| S114.3.117 Goryokai Hospital | Hokkaido Prefecture | Japan |
| S114.3.117 Kobe University Hospital | Hyogo Prefecture | Japan |
| S114.3.117 National Hospital Organization Kagawa C | Kagawa Prefecture | Japan |
| S114.3.117 Yokohama City University Hospital | Kanagawa Prefecture | Japan |
| S114.3.117 National Hospital Organization Kikuti N | Kumamoto Prefecture | Japan |
| S114.3.117 Kyoto University Hospital | Kyoto Prefecture | Japan |
| S114.3.117 National Hospital Organization Sakakiba | Mie Prefecuture | Japan |
| S114.3.117 Shinshu University Hospital | Nagano Prefecture | Japan |
| S114.3.117 Aichi Children's Health and Medical Cen | Nagoya Prefecture | Japan |
| S114.3.117 Nagoya Mental Clinic | Nagoya Prefecture | Japan |
| S114.3.117 Nara Medical University Hospital | Nara Prefecture | Japan |
| S114.3.117 Kansai Medical University Takii Hospita | Osaka Prefecture | Japan |
| S114.3.117 Kusube Clinic | Osaka Prefecture | Japan |
| S114.3.117 Yasuhara Children's Clinic | Osaka Prefecture | Japan |
| S114.3.117 Tokushima University Hospital | Tokushima Prefecture | Japan |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016666 | Fluvoxamine |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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