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This study was prematurely terminated (26 June 2009) due to slow recruitment
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This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder
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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 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Global Impression(CGI) improvement at Week 10 | 10 weeks |
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Inclusion Criteria Have a minimum total score of 16 on the JCY-BOCS, 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 |
|---|---|---|---|---|---|---|
| S114.3.118 Kohnodai Hospital, National Center of N | Chiba Prefecture | Japan | ||||
| S114.3.118 Kyushu University Hospital |
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|
| Placebo | Drug | Placebo |
|
| Fukuoka Prefecture |
| Japan |
| S114.3.118 Hiroshima-city Funairi Hospital | Hiroshima Prefecture | Japan |
| S114.3.118 Goryokai Hospital | Hokkaido Prefecture | Japan |
| S114.3.118 Hyogo Children's Hospital | Hyogo Prefecture | Japan |
| S114.3.118 Kobe University Hospital | Hyogo Prefecture | Japan |
| S114.3.118 National Hospital Organization Kagawa C | Kagawa Prefecture | Japan |
| S114.3.118 National Hospital Organization Kikuti N | Kumamoto Prefecture | Japan |
| S114.3.118 National Hospital Organization Sakakiba | Mie Prefecuture | Japan |
| S114.3.118 Nara Medical University Hospital | Nara Prefecture | Japan |
| S114.3.118 Tokushima University Hospital | Tokushima Prefecture | Japan |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016666 | Fluvoxamine |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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