- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00614575
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
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Akashi, 일본
- Boehringer Ingelheim Investigational Site
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Akita, 일본
- Boehringer Ingelheim Investigational Site 1
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Akita, 일본
- Boehringer Ingelheim Investigational Site 2
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Asahikawa, 일본
- Boehringer Ingelheim Investigational Site
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Ashikaga, 일본
- Boehringer Ingelheim Investigational Site
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Awaji, 일본
- Boehringer Ingelheim Investigational Site
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Chitose, 일본
- Boehringer Ingelheim Investigational Site
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Chuo, 일본
- Boehringer Ingelheim Investigational Site
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Fuchu, 일본
- Boehringer Ingelheim Investigational Site 1
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Fuchu, 일본
- Boehringer Ingelheim Investigational Site 2
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Fuefuki, 일본
- Boehringer Ingelheim Investigational Site
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Fuehuki, 일본
- Boehringer Ingelheim Investigational Site
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Fujioka, 일본
- Boehringer Ingelheim Investigational Site
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Fujisaki, 일본
- Boehringer Ingelheim Investigational Site
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Fujisawa, 일본
- Boehringer Ingelheim Investigational Site
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Fukaya, 일본
- Boehringer Ingelheim Investigational Site
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Fukuoka, 일본
- Boehringer Ingelheim Investigational Site 1
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Fukuoka, 일본
- Boehringer Ingelheim Investigational Site 2
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Fukuoka, 일본
- Boehringer Ingelheim Investigational Site 3
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Fukuoka, 일본
- Boehringer Ingelheim Investigational Site 4
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Fukuoka, 일본
- Boehringer Ingelheim Investigational Site 5
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Fukushima, 일본
- Boehringer Ingelheim Investigational Site 1
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Fukushima, 일본
- Boehringer Ingelheim Investigational Site 2
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Funabashi, 일본
- Boehringer Ingelheim Investigational Site
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Gifu, 일본
- Boehringer Ingelheim Investigational Site 1
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Gifu, 일본
- Boehringer Ingelheim Investigational Site 2
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Habikino, 일본
- Boehringer Ingelheim Investigational Site
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Hachioji, 일본
- Boehringer Ingelheim Investigational Site
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Hamamatsu, 일본
- Boehringer Ingelheim Investigational Site 1
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Hamamatsu, 일본
- Boehringer Ingelheim Investigational Site 2
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Hamamatsu, 일본
- Boehringer Ingelheim Investigational Site 3
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Hamamatsu, 일본
- Boehringer Ingelheim Investigational Site 4
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Hamamatsu, 일본
- Boehringer Ingelheim Investigational Site 5
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Hanamaki, 일본
- Boehringer Ingelheim Investigational Site
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Hayashima, 일본
- Boehringer Ingelheim Investigational Site
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Higashiosaka, 일본
- Boehringer Ingelheim Investigational Site 1
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Higashiosaka, 일본
- Boehringer Ingelheim Investigational Site 2
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Himeji, 일본
- Boehringer Ingelheim Investigational Site
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Hirakata, 일본
- Boehringer Ingelheim Investigational Site
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Hirishima, 일본
- Boehringer Ingelheim Investigational Site
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Hirosaki, 일본
- Boehringer Ingelheim Investigational Site
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Ibaragi, 일본
- Boehringer Ingelheim Investigational Site
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Iizuka, 일본
- Boehringer Ingelheim Investigational Site
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Inag, 일본
- Boehringer Ingelheim Investigational Site
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Irima, 일본
- Boehringer Ingelheim Investigational Site
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Isahaya, 일본
- Boehringer Ingelheim Investigational Site
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Iwaki, 일본
- Boehringer Ingelheim Investigational Site
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Iwamizawa, 일본
- Boehringer Ingelheim Investigational Site
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Iwata, 일본
- Boehringer Ingelheim Investigational Site
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Jyoetsu, 일본
- Boehringer Ingelheim Investigational Site 1
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Jyoetsu, 일본
- Boehringer Ingelheim Investigational Site 2
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Jyoyo, 일본
- Boehringer Ingelheim Investigational Site
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Kagoshima, 일본
- Boehringer Ingelheim Investigational Site 1
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Kagoshima, 일본
- Boehringer Ingelheim Investigational Site 2
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Kagoshima, 일본
- Boehringer Ingelheim Investigational Site 3
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Kahoku, 일본
- Boehringer Ingelheim Investigational Site
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Kamakura, 일본
- Boehringer Ingelheim Investigational Site
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Kanazawa, 일본
- Boehringer Ingelheim Investigational Site 1
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Kanazawa, 일본
- Boehringer Ingelheim Investigational Site 2
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Kanoya, 일본
- Boehringer Ingelheim Investigational Site 1
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Kanoya, 일본
- Boehringer Ingelheim Investigational Site 2
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Kashihara, 일본
- Boehringer Ingelheim Investigational Site 1
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Kashihara, 일본
- Boehringer Ingelheim Investigational Site 2
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Kasuga, 일본
- Boehringer Ingelheim Investigational Site
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Kawagchi, 일본
- Boehringer Ingelheim Investigational Site
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Kawaguchi, 일본
- Boehringer Ingelheim Investigational Site
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Kawasaki, 일본
- Boehringer Ingelheim Investigational Site 1
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Kawasaki, 일본
- Boehringer Ingelheim Investigational Site 2
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Kitakami, 일본
- Boehringer Ingelheim Investigational Site
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Kiyose, 일본
- Boehringer Ingelheim Investigational Site 1
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Kiyose, 일본
- Boehringer Ingelheim Investigational Site 2
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Kodaira, 일본
- Boehringer Ingelheim Investigational Site
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Kofu, 일본
- Boehringer Ingelheim Investigational Site
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Koga, 일본
- Boehringer Ingelheim Investigational Site
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Komae, 일본
- Boehringer Ingelheim Investigational Site
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Komatsu, 일본
- Boehringer Ingelheim Investigational Site
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Komatsushima, 일본
- Boehringer Ingelheim Investigational Site
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Koriyama, 일본
- Boehringer Ingelheim Investigational Site 1
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Koriyama, 일본
- Boehringer Ingelheim Investigational Site 2
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Koshigaya, 일본
- Boehringer Ingelheim Investigational Site
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Kumamoto, 일본
- Boehringer Ingelheim Investigational Site 1
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Kumamoto, 일본
- Boehringer Ingelheim Investigational Site 2
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Kumamoto, 일본
- Boehringer Ingelheim Investigational Site 3
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Kure, 일본
- Boehringer Ingelheim Investigational Site
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Kusatsu, 일본
- Boehringer Ingelheim Investigational Site
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Kyoto, 일본
- Boehringer Ingelheim Investigational Site 1
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Kyoto, 일본
- Boehringer Ingelheim Investigational Site 2
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Kyoto, 일본
- Boehringer Ingelheim Investigational Site 3
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Kyoto, 일본
- Boehringer Ingelheim Investigational Site 4
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Maebashi, 일본
- Boehringer Ingelheim Investigational Site
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Matsudo, 일본
- Boehringer Ingelheim Investigational Site
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Matsumoto, 일본
- Boehringer Ingelheim Investigational Site
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Mibu, 일본
- Boehringer Ingelheim Investigational Site
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Mihara, 일본
- Boehringer Ingelheim Investigational Site
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Mihoro, 일본
- Boehringer Ingelheim Investigational Site
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Miriyama, 일본
- Boehringer Ingelheim Investigational Site
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Misato, 일본
- Boehringer Ingelheim Investigational Site
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Miyako, 일본
- Boehringer Ingelheim Investigational Site
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Miyazaki, 일본
- Boehringer Ingelheim Investigational Site 1
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Miyazaki, 일본
- Boehringer Ingelheim Investigational Site 2
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Moriguchi, 일본
- Boehringer Ingelheim Investigational Site
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Morioka, 일본
- Boehringer Ingelheim Investigational Site 1
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Morioka, 일본
- Boehringer Ingelheim Investigational Site 2
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Moriya, 일본
- Boehringer Ingelheim Investigational Site
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Musashino, 일본
- Boehringer Ingelheim Investigational Site
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Nagano, 일본
- Boehringer Ingelheim Investigational Site
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Nagaoka, 일본
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, 일본
- Boehringer Ingelheim Investigational Site
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Nagoya, 일본
- Boehringer Ingelheim Investigational Site 1
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Nagoya, 일본
- Boehringer Ingelheim Investigational Site 2
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Nagoya, 일본
- Boehringer Ingelheim Investigational Site 3
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Nagoya, 일본
- Boehringer Ingelheim Investigational Site 4
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Nara, 일본
- Boehringer Ingelheim Investigational Site 1
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Nara, 일본
- Boehringer Ingelheim Investigational Site 2
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Narashino, 일본
- Boehringer Ingelheim Investigational Site
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Narita, 일본
- Boehringer Ingelheim Investigational Site
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Naruto, 일본
- Boehringer Ingelheim Investigational Site
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Nasushiobara, 일본
- Boehringer Ingelheim Investigational Site
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Nichinan, 일본
- Boehringer Ingelheim Investigational Site
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Ninohe, 일본
- Boehringer Ingelheim Investigational Site
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Nishinomiya, 일본
- Boehringer Ingelheim Investigational Site
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Nishitokyo, 일본
- Boehringer Ingelheim Investigational Site
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Ogaki, 일본
- Boehringer Ingelheim Investigational Site
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Oiso, 일본
- Boehringer Ingelheim Investigational Site
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Oita, 일본
- Boehringer Ingelheim Investigational Site 1
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Oita, 일본
- Boehringer Ingelheim Investigational Site 2
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Oita, 일본
- Boehringer Ingelheim Investigational Site 3
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Okaya, 일본
- Boehringer Ingelheim Investigational Site
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Okayama, 일본
- Boehringer Ingelheim Investigational Site 1
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Okayama, 일본
- Boehringer Ingelheim Investigational Site 2
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Okazaki, 일본
- Boehringer Ingelheim Investigational Site
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Okinawa, 일본
- Boehringer Ingelheim Investigational Site
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Omura, 일본
- Boehringer Ingelheim Investigational Site
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Omuta, 일본
- Boehringer Ingelheim Investigational Site
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Onojyo, 일본
- Boehringer Ingelheim Investigational Site
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 1
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 2
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 3
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 4
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 5
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Osaka, 일본
- Boehringer Ingelheim Investigational Site 6
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Ota, 일본
- Boehringer Ingelheim Investigational Site
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Otake, 일본
- Boehringer Ingelheim Investigational Site
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Otsu, 일본
- Boehringer Ingelheim Investigational Site
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Ryugasaki, 일본
- Boehringer Ingelheim Investigational Site
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Saeki, 일본
- Boehringer Ingelheim Investigational Site
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Saga, 일본
- Boehringer Ingelheim Investigational Site
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Sagamihara, 일본
- Boehringer Ingelheim Investigational Site 1
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Sagamihara, 일본
- Boehringer Ingelheim Investigational Site 2
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Sagamihara, 일본
- Boehringer Ingelheim Investigational Site 3
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Saijyo, 일본
- Boehringer Ingelheim Investigational Site
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Saitama, 일본
- Boehringer Ingelheim Investigational Site
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Sakai, 일본
- Boehringer Ingelheim Investigational Site 1
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Sakai, 일본
- Boehringer Ingelheim Investigational Site 2
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 3
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 4
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 5
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 6
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 8
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 9
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 7
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 1
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Sapporo, 일본
- Boehringer Ingelheim Investigational Site 2
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Sekigahara, 일본
- Boehringer Ingelheim Investigational Site
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Sendai, 일본
- Boehringer Ingelheim Investigational Site 1
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Sendai, 일본
- Boehringer Ingelheim Investigational Site 2
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Shimoda, 일본
- Boehringer Ingelheim Investigational Site
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Shimotsuke, 일본
- Boehringer Ingelheim Investigational Site 1
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Shimotsuke, 일본
- Boehringer Ingelheim Investigational Site 2
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Shinngu, 일본
- Boehringer Ingelheim Investigational Site
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Shiroishi, 일본
- Boehringer Ingelheim Investigational Site
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Shizuoka, 일본
- Boehringer Ingelheim Investigational Site 1
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Shizuoka, 일본
- Boehringer Ingelheim Investigational Site 2
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Showajima, 일본
- Boehringer Ingelheim Investigational Site
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Suita, 일본
- Boehringer Ingelheim Investigational Site 1
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Suita, 일본
- Boehringer Ingelheim Investigational Site 2
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Susono, 일본
- Boehringer Ingelheim Investigational Site
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Suzuka, 일본
- Boehringer Ingelheim Investigational Site
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Takaoka, 일본
- Boehringer Ingelheim Investigational Site 1
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Takaoka, 일본
- Boehringer Ingelheim Investigational Site 2
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Takatsuki, 일본
- Boehringer Ingelheim Investigational Site
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Tarimizu, 일본
- Boehringer Ingelheim Investigational Site
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Togitsu, 일본
- Boehringer Ingelheim Investigational Site
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Tokoname, 일본
- Boehringer Ingelheim Investigational Site
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Tokushima, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Arakawa-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Chuo-ku, 일본
- Boehringer Ingelheim Investigational Site 1
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Tokyo Chuo-ku, 일본
- Boehringer Ingelheim Investigational Site 2
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Tokyo Daito-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Koto-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, 일본
- Boehringer Ingelheim Investigational Site 1
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Tokyo Meguro-ku, 일본
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, 일본
- Boehringer Ingelheim Investigational Site 1
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Tokyo Minato-ku, 일본
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, 일본
- Boehringer Ingelheim Investigational Site 3
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Tokyo Nakano-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, 일본
- Boehringer Ingelheim Investigational Site 1
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Tokyo Ota-ku, 일본
- Boehringer Ingelheim Investigational Site 2
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Tokyo Setagaya, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Shibuya-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjyuku-ku, 일본
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku, 일본
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku, 일본
- Boehringer Ingelheim Investigational Site 3
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Tokyo Sibuya-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo-Edogawa-ku, 일본
- Boehringer Ingelheim Investigational Site
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Tokyo-Itabashi-ku, 일본
- Boehringer Ingelheim Investigational Site
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Toride, 일본
- Boehringer Ingelheim Investigational Site
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Tosu, 일본
- Boehringer Ingelheim Investigational Site
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Toyama, 일본
- Boehringer Ingelheim Investigational Site 1
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Toyama, 일본
- Boehringer Ingelheim Investigational Site 2
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Toyama, 일본
- Boehringer Ingelheim Investigational Site 3
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Toyohashi, 일본
- Boehringer Ingelheim Investigational Site
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Toyokawa, 일본
- Boehringer Ingelheim Investigational Site
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Toyonaka, 일본
- Boehringer Ingelheim Investigational Site
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Ube, 일본
- Boehringer Ingelheim Investigational Site
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Uchinada, 일본
- Boehringer Ingelheim Investigational Site
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Ueda, 일본
- Boehringer Ingelheim Investigational Site
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Ushiku, 일본
- Boehringer Ingelheim Investigational Site
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Utsunomiya, 일본
- Boehringer Ingelheim Investigational Site 1
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Utsunomiya, 일본
- Boehringer Ingelheim Investigational Site 2
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Wakayama, 일본
- Boehringer Ingelheim Investigational Site
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Yachiyo, 일본
- Boehringer Ingelheim Investigational Site 1
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Yachiyo, 일본
- Boehringer Ingelheim Investigational Site 2
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Yachiyo, 일본
- Boehringer Ingelheim Investigational Site 3
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Yamanashi, 일본
- Boehringer Ingelheim Investigational Site
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Yanago, 일본
- Boehringer Ingelheim Investigational Site
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Yoichi, 일본
- Boehringer Ingelheim Investigational Site
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Yokohama, 일본
- Boehringer Ingelheim Investigational Site 1
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Yokohama, 일본
- Boehringer Ingelheim Investigational Site 2
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Yokohama, 일본
- Boehringer Ingelheim Investigational Site 3
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Yokohama, 일본
- Boehringer Ingelheim Investigational Site 4
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Yokosuka, 일본
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, 일본
- Boehringer Ingelheim Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
기간: for 12 weeks
|
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.
|
for 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Clinical Global Impression of Improvement
기간: for 12 weeks after initiation of the treatment
|
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).
|
for 12 weeks after initiation of the treatment
|
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
기간: 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.
|
Baseline and after 12 weeks (or at the time of discontinuation)
|
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
기간: Baseline and after 12 weeks (or at the time of discontinuation)
|
The degree of severity in depressive state are scored between 0-63 in BDI.
A decrease in the score means improvement.
|
Baseline and after 12 weeks (or at the time of discontinuation)
|
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
기간: Baseline and after 12 weeks (or at the time of discontinuation)
|
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.
|
Baseline and after 12 weeks (or at the time of discontinuation)
|
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .