Survey on PD Patients With Depressive Symptoms
BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.
i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Akashi、日本
- Boehringer Ingelheim Investigational Site
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Akita、日本
- Boehringer Ingelheim Investigational Site 1
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Akita、日本
- Boehringer Ingelheim Investigational Site 2
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Asahikawa、日本
- Boehringer Ingelheim Investigational Site
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Ashikaga、日本
- Boehringer Ingelheim Investigational Site
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Awaji、日本
- Boehringer Ingelheim Investigational Site
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Chitose、日本
- Boehringer Ingelheim Investigational Site
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Chuo、日本
- Boehringer Ingelheim Investigational Site
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Fuchu、日本
- Boehringer Ingelheim Investigational Site 1
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Fuchu、日本
- Boehringer Ingelheim Investigational Site 2
-
Fuefuki、日本
- Boehringer Ingelheim Investigational Site
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Fuehuki、日本
- Boehringer Ingelheim Investigational Site
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Fujioka、日本
- Boehringer Ingelheim Investigational Site
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Fujisaki、日本
- Boehringer Ingelheim Investigational Site
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Fujisawa、日本
- Boehringer Ingelheim Investigational Site
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Fukaya、日本
- Boehringer Ingelheim Investigational Site
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Fukuoka、日本
- Boehringer Ingelheim Investigational Site 1
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Fukuoka、日本
- Boehringer Ingelheim Investigational Site 2
-
Fukuoka、日本
- Boehringer Ingelheim Investigational Site 3
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Fukuoka、日本
- Boehringer Ingelheim Investigational Site 4
-
Fukuoka、日本
- Boehringer Ingelheim Investigational Site 5
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Fukushima、日本
- Boehringer Ingelheim Investigational Site 1
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Fukushima、日本
- Boehringer Ingelheim Investigational Site 2
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Funabashi、日本
- Boehringer Ingelheim Investigational Site
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Gifu、日本
- Boehringer Ingelheim Investigational Site 1
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Gifu、日本
- Boehringer Ingelheim Investigational Site 2
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Habikino、日本
- Boehringer Ingelheim Investigational Site
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Hachioji、日本
- Boehringer Ingelheim Investigational Site
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Hamamatsu、日本
- Boehringer Ingelheim Investigational Site 1
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Hamamatsu、日本
- Boehringer Ingelheim Investigational Site 2
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Hamamatsu、日本
- Boehringer Ingelheim Investigational Site 3
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Hamamatsu、日本
- Boehringer Ingelheim Investigational Site 4
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Hamamatsu、日本
- Boehringer Ingelheim Investigational Site 5
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Hanamaki、日本
- Boehringer Ingelheim Investigational Site
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Hayashima、日本
- Boehringer Ingelheim Investigational Site
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Higashiosaka、日本
- Boehringer Ingelheim Investigational Site 1
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Higashiosaka、日本
- Boehringer Ingelheim Investigational Site 2
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Himeji、日本
- Boehringer Ingelheim Investigational Site
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Hirakata、日本
- Boehringer Ingelheim Investigational Site
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Hirishima、日本
- Boehringer Ingelheim Investigational Site
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Hirosaki、日本
- Boehringer Ingelheim Investigational Site
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Ibaragi、日本
- Boehringer Ingelheim Investigational Site
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Iizuka、日本
- Boehringer Ingelheim Investigational Site
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Inag、日本
- Boehringer Ingelheim Investigational Site
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Irima、日本
- Boehringer Ingelheim Investigational Site
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Isahaya、日本
- Boehringer Ingelheim Investigational Site
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Iwaki、日本
- Boehringer Ingelheim Investigational Site
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Iwamizawa、日本
- Boehringer Ingelheim Investigational Site
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Iwata、日本
- Boehringer Ingelheim Investigational Site
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Jyoetsu、日本
- Boehringer Ingelheim Investigational Site 1
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Jyoetsu、日本
- Boehringer Ingelheim Investigational Site 2
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Jyoyo、日本
- Boehringer Ingelheim Investigational Site
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Kagoshima、日本
- Boehringer Ingelheim Investigational Site 1
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Kagoshima、日本
- Boehringer Ingelheim Investigational Site 2
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Kagoshima、日本
- Boehringer Ingelheim Investigational Site 3
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Kahoku、日本
- Boehringer Ingelheim Investigational Site
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Kamakura、日本
- Boehringer Ingelheim Investigational Site
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Kanazawa、日本
- Boehringer Ingelheim Investigational Site 1
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Kanazawa、日本
- Boehringer Ingelheim Investigational Site 2
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Kanoya、日本
- Boehringer Ingelheim Investigational Site 1
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Kanoya、日本
- Boehringer Ingelheim Investigational Site 2
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Kashihara、日本
- Boehringer Ingelheim Investigational Site 1
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Kashihara、日本
- Boehringer Ingelheim Investigational Site 2
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Kasuga、日本
- Boehringer Ingelheim Investigational Site
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Kawagchi、日本
- Boehringer Ingelheim Investigational Site
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Kawaguchi、日本
- Boehringer Ingelheim Investigational Site
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Kawasaki、日本
- Boehringer Ingelheim Investigational Site 1
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Kawasaki、日本
- Boehringer Ingelheim Investigational Site 2
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Kitakami、日本
- Boehringer Ingelheim Investigational Site
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Kiyose、日本
- Boehringer Ingelheim Investigational Site 1
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Kiyose、日本
- Boehringer Ingelheim Investigational Site 2
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Kodaira、日本
- Boehringer Ingelheim Investigational Site
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Kofu、日本
- Boehringer Ingelheim Investigational Site
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Koga、日本
- Boehringer Ingelheim Investigational Site
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Komae、日本
- Boehringer Ingelheim Investigational Site
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Komatsu、日本
- Boehringer Ingelheim Investigational Site
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Komatsushima、日本
- Boehringer Ingelheim Investigational Site
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Koriyama、日本
- Boehringer Ingelheim Investigational Site 1
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Koriyama、日本
- Boehringer Ingelheim Investigational Site 2
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Koshigaya、日本
- Boehringer Ingelheim Investigational Site
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Kumamoto、日本
- Boehringer Ingelheim Investigational Site 1
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Kumamoto、日本
- Boehringer Ingelheim Investigational Site 2
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Kumamoto、日本
- Boehringer Ingelheim Investigational Site 3
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Kure、日本
- Boehringer Ingelheim Investigational Site
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Kusatsu、日本
- Boehringer Ingelheim Investigational Site
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Kyoto、日本
- Boehringer Ingelheim Investigational Site 1
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Kyoto、日本
- Boehringer Ingelheim Investigational Site 2
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Kyoto、日本
- Boehringer Ingelheim Investigational Site 3
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Kyoto、日本
- Boehringer Ingelheim Investigational Site 4
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Maebashi、日本
- Boehringer Ingelheim Investigational Site
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Matsudo、日本
- Boehringer Ingelheim Investigational Site
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Matsumoto、日本
- Boehringer Ingelheim Investigational Site
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Mibu、日本
- Boehringer Ingelheim Investigational Site
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Mihara、日本
- Boehringer Ingelheim Investigational Site
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Mihoro、日本
- Boehringer Ingelheim Investigational Site
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Miriyama、日本
- Boehringer Ingelheim Investigational Site
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Misato、日本
- Boehringer Ingelheim Investigational Site
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Miyako、日本
- Boehringer Ingelheim Investigational Site
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Miyazaki、日本
- Boehringer Ingelheim Investigational Site 1
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Miyazaki、日本
- Boehringer Ingelheim Investigational Site 2
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Moriguchi、日本
- Boehringer Ingelheim Investigational Site
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Morioka、日本
- Boehringer Ingelheim Investigational Site 1
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Morioka、日本
- Boehringer Ingelheim Investigational Site 2
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Moriya、日本
- Boehringer Ingelheim Investigational Site
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Musashino、日本
- Boehringer Ingelheim Investigational Site
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Nagano、日本
- Boehringer Ingelheim Investigational Site
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Nagaoka、日本
- Boehringer Ingelheim Investigational Site
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Nagaokakyo、日本
- Boehringer Ingelheim Investigational Site
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Nagoya、日本
- Boehringer Ingelheim Investigational Site 1
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Nagoya、日本
- Boehringer Ingelheim Investigational Site 2
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Nagoya、日本
- Boehringer Ingelheim Investigational Site 3
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Nagoya、日本
- Boehringer Ingelheim Investigational Site 4
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Nara、日本
- Boehringer Ingelheim Investigational Site 1
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Nara、日本
- Boehringer Ingelheim Investigational Site 2
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Narashino、日本
- Boehringer Ingelheim Investigational Site
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Narita、日本
- Boehringer Ingelheim Investigational Site
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Naruto、日本
- Boehringer Ingelheim Investigational Site
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Nasushiobara、日本
- Boehringer Ingelheim Investigational Site
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Nichinan、日本
- Boehringer Ingelheim Investigational Site
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Ninohe、日本
- Boehringer Ingelheim Investigational Site
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Nishinomiya、日本
- Boehringer Ingelheim Investigational Site
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Nishitokyo、日本
- Boehringer Ingelheim Investigational Site
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Ogaki、日本
- Boehringer Ingelheim Investigational Site
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Oiso、日本
- Boehringer Ingelheim Investigational Site
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Oita、日本
- Boehringer Ingelheim Investigational Site 1
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Oita、日本
- Boehringer Ingelheim Investigational Site 2
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Oita、日本
- Boehringer Ingelheim Investigational Site 3
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Okaya、日本
- Boehringer Ingelheim Investigational Site
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Okayama、日本
- Boehringer Ingelheim Investigational Site 1
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Okayama、日本
- Boehringer Ingelheim Investigational Site 2
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Okazaki、日本
- Boehringer Ingelheim Investigational Site
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Okinawa、日本
- Boehringer Ingelheim Investigational Site
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Omura、日本
- Boehringer Ingelheim Investigational Site
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Omuta、日本
- Boehringer Ingelheim Investigational Site
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Onojyo、日本
- Boehringer Ingelheim Investigational Site
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Osaka、日本
- Boehringer Ingelheim Investigational Site 1
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Osaka、日本
- Boehringer Ingelheim Investigational Site 2
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Osaka、日本
- Boehringer Ingelheim Investigational Site 3
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Osaka、日本
- Boehringer Ingelheim Investigational Site 4
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Osaka、日本
- Boehringer Ingelheim Investigational Site 5
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Osaka、日本
- Boehringer Ingelheim Investigational Site 6
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Ota、日本
- Boehringer Ingelheim Investigational Site
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Otake、日本
- Boehringer Ingelheim Investigational Site
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Otsu、日本
- Boehringer Ingelheim Investigational Site
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Ryugasaki、日本
- Boehringer Ingelheim Investigational Site
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Saeki、日本
- Boehringer Ingelheim Investigational Site
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Saga、日本
- Boehringer Ingelheim Investigational Site
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Sagamihara、日本
- Boehringer Ingelheim Investigational Site 1
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Sagamihara、日本
- Boehringer Ingelheim Investigational Site 2
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Sagamihara、日本
- Boehringer Ingelheim Investigational Site 3
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Saijyo、日本
- Boehringer Ingelheim Investigational Site
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Saitama、日本
- Boehringer Ingelheim Investigational Site
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Sakai、日本
- Boehringer Ingelheim Investigational Site 1
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Sakai、日本
- Boehringer Ingelheim Investigational Site 2
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 3
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 4
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 5
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 6
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 8
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 9
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 7
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 1
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Sapporo、日本
- Boehringer Ingelheim Investigational Site 2
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Sekigahara、日本
- Boehringer Ingelheim Investigational Site
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Sendai、日本
- Boehringer Ingelheim Investigational Site 1
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Sendai、日本
- Boehringer Ingelheim Investigational Site 2
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Shimoda、日本
- Boehringer Ingelheim Investigational Site
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Shimotsuke、日本
- Boehringer Ingelheim Investigational Site 1
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Shimotsuke、日本
- Boehringer Ingelheim Investigational Site 2
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Shinngu、日本
- Boehringer Ingelheim Investigational Site
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Shiroishi、日本
- Boehringer Ingelheim Investigational Site
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Shizuoka、日本
- Boehringer Ingelheim Investigational Site 1
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Shizuoka、日本
- Boehringer Ingelheim Investigational Site 2
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Showajima、日本
- Boehringer Ingelheim Investigational Site
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Suita、日本
- Boehringer Ingelheim Investigational Site 1
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Suita、日本
- Boehringer Ingelheim Investigational Site 2
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Susono、日本
- Boehringer Ingelheim Investigational Site
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Suzuka、日本
- Boehringer Ingelheim Investigational Site
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Takaoka、日本
- Boehringer Ingelheim Investigational Site 1
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Takaoka、日本
- Boehringer Ingelheim Investigational Site 2
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Takatsuki、日本
- Boehringer Ingelheim Investigational Site
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Tarimizu、日本
- Boehringer Ingelheim Investigational Site
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Togitsu、日本
- Boehringer Ingelheim Investigational Site
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Tokoname、日本
- Boehringer Ingelheim Investigational Site
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Tokushima、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Arakawa-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Chuo-ku、日本
- Boehringer Ingelheim Investigational Site 1
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Tokyo Chuo-ku、日本
- Boehringer Ingelheim Investigational Site 2
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Tokyo Daito-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Koto-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku、日本
- Boehringer Ingelheim Investigational Site 1
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Tokyo Meguro-ku、日本
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku、日本
- Boehringer Ingelheim Investigational Site 1
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Tokyo Minato-ku、日本
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku、日本
- Boehringer Ingelheim Investigational Site 3
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Tokyo Nakano-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku、日本
- Boehringer Ingelheim Investigational Site 1
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Tokyo Ota-ku、日本
- Boehringer Ingelheim Investigational Site 2
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Tokyo Setagaya、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Shibuya-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjyuku-ku、日本
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku、日本
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku、日本
- Boehringer Ingelheim Investigational Site 3
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Tokyo Sibuya-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo-Edogawa-ku、日本
- Boehringer Ingelheim Investigational Site
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Tokyo-Itabashi-ku、日本
- Boehringer Ingelheim Investigational Site
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Toride、日本
- Boehringer Ingelheim Investigational Site
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Tosu、日本
- Boehringer Ingelheim Investigational Site
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Toyama、日本
- Boehringer Ingelheim Investigational Site 1
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Toyama、日本
- Boehringer Ingelheim Investigational Site 2
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Toyama、日本
- Boehringer Ingelheim Investigational Site 3
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Toyohashi、日本
- Boehringer Ingelheim Investigational Site
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Toyokawa、日本
- Boehringer Ingelheim Investigational Site
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Toyonaka、日本
- Boehringer Ingelheim Investigational Site
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Ube、日本
- Boehringer Ingelheim Investigational Site
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Uchinada、日本
- Boehringer Ingelheim Investigational Site
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Ueda、日本
- Boehringer Ingelheim Investigational Site
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Ushiku、日本
- Boehringer Ingelheim Investigational Site
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Utsunomiya、日本
- Boehringer Ingelheim Investigational Site 1
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Utsunomiya、日本
- Boehringer Ingelheim Investigational Site 2
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Wakayama、日本
- Boehringer Ingelheim Investigational Site
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Yachiyo、日本
- Boehringer Ingelheim Investigational Site 1
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Yachiyo、日本
- Boehringer Ingelheim Investigational Site 2
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Yachiyo、日本
- Boehringer Ingelheim Investigational Site 3
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Yamanashi、日本
- Boehringer Ingelheim Investigational Site
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Yanago、日本
- Boehringer Ingelheim Investigational Site
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Yoichi、日本
- Boehringer Ingelheim Investigational Site
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Yokohama、日本
- Boehringer Ingelheim Investigational Site 1
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Yokohama、日本
- Boehringer Ingelheim Investigational Site 2
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Yokohama、日本
- Boehringer Ingelheim Investigational Site 3
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Yokohama、日本
- Boehringer Ingelheim Investigational Site 4
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Yokosuka、日本
- Boehringer Ingelheim Investigational Site
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Yoshinogawa、日本
- Boehringer Ingelheim Investigational Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
**PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.
Exclusion criteria:
- PD patients with the past history of suicidal attempt, suicidal ideation or tendency
- PD patients with suicidal ideation
- PD patients with the past history of suicidal tendency
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
時間枠:for 12 weeks
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The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms.
The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
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for 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Global Impression of Improvement
時間枠:for 12 weeks after initiation of the treatment
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Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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for 12 weeks after initiation of the treatment
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Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
時間枠:Baseline and after 12 weeks (or at the time of discontinuation)
|
Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction).
The total score ranged from 0 to 56.
A negative change in the Part III total score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
時間枠:Baseline and after 12 weeks (or at the time of discontinuation)
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The degree of severity in depressive state are scored between 0-63 in BDI.
A decrease in the score means improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
時間枠:Baseline and after 12 weeks (or at the time of discontinuation)
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Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression.
Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent).
A higher score indicates more severe depression symptoms.
A negative change in the item 3 score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
時間枠:After 12 weeks or at the time of discontinuation
|
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease.
The scale ranges from 0 (No signs) to 5 (Bedridden).
A negative change in the Yahr rating scale indicates improvement.
|
After 12 weeks or at the time of discontinuation
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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。