- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Akashi, Japan
- Boehringer Ingelheim Investigational Site
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Akita, Japan
- Boehringer Ingelheim Investigational Site 1
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Akita, Japan
- Boehringer Ingelheim Investigational Site 2
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Asahikawa, Japan
- Boehringer Ingelheim Investigational Site
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Ashikaga, Japan
- Boehringer Ingelheim Investigational Site
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Awaji, Japan
- Boehringer Ingelheim Investigational Site
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Chitose, Japan
- Boehringer Ingelheim Investigational Site
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Chuo, Japan
- Boehringer Ingelheim Investigational Site
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Fuchu, Japan
- Boehringer Ingelheim Investigational Site 1
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Fuchu, Japan
- Boehringer Ingelheim Investigational Site 2
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Fuefuki, Japan
- Boehringer Ingelheim Investigational Site
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Fuehuki, Japan
- Boehringer Ingelheim Investigational Site
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Fujioka, Japan
- Boehringer Ingelheim Investigational Site
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Fujisaki, Japan
- Boehringer Ingelheim Investigational Site
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Fujisawa, Japan
- Boehringer Ingelheim Investigational Site
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Fukaya, Japan
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site 1
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site 2
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site 3
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site 4
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site 5
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Fukushima, Japan
- Boehringer Ingelheim Investigational Site 1
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Fukushima, Japan
- Boehringer Ingelheim Investigational Site 2
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Funabashi, Japan
- Boehringer Ingelheim Investigational Site
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Gifu, Japan
- Boehringer Ingelheim Investigational Site 1
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Gifu, Japan
- Boehringer Ingelheim Investigational Site 2
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Habikino, Japan
- Boehringer Ingelheim Investigational Site
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Hachioji, Japan
- Boehringer Ingelheim Investigational Site
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site 1
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site 2
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site 3
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site 4
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site 5
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Hanamaki, Japan
- Boehringer Ingelheim Investigational Site
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Hayashima, Japan
- Boehringer Ingelheim Investigational Site
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Higashiosaka, Japan
- Boehringer Ingelheim Investigational Site 1
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Higashiosaka, Japan
- Boehringer Ingelheim Investigational Site 2
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Himeji, Japan
- Boehringer Ingelheim Investigational Site
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Hirakata, Japan
- Boehringer Ingelheim Investigational Site
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Hirishima, Japan
- Boehringer Ingelheim Investigational Site
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Hirosaki, Japan
- Boehringer Ingelheim Investigational Site
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Ibaragi, Japan
- Boehringer Ingelheim Investigational Site
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Iizuka, Japan
- Boehringer Ingelheim Investigational Site
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Inag, Japan
- Boehringer Ingelheim Investigational Site
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Irima, Japan
- Boehringer Ingelheim Investigational Site
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Isahaya, Japan
- Boehringer Ingelheim Investigational Site
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Iwaki, Japan
- Boehringer Ingelheim Investigational Site
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Iwamizawa, Japan
- Boehringer Ingelheim Investigational Site
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Iwata, Japan
- Boehringer Ingelheim Investigational Site
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Jyoetsu, Japan
- Boehringer Ingelheim Investigational Site 1
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Jyoetsu, Japan
- Boehringer Ingelheim Investigational Site 2
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Jyoyo, Japan
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japan
- Boehringer Ingelheim Investigational Site 1
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Kagoshima, Japan
- Boehringer Ingelheim Investigational Site 2
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Kagoshima, Japan
- Boehringer Ingelheim Investigational Site 3
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Kahoku, Japan
- Boehringer Ingelheim Investigational Site
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Kamakura, Japan
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japan
- Boehringer Ingelheim Investigational Site 1
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Kanazawa, Japan
- Boehringer Ingelheim Investigational Site 2
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Kanoya, Japan
- Boehringer Ingelheim Investigational Site 1
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Kanoya, Japan
- Boehringer Ingelheim Investigational Site 2
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Kashihara, Japan
- Boehringer Ingelheim Investigational Site 1
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Kashihara, Japan
- Boehringer Ingelheim Investigational Site 2
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Kasuga, Japan
- Boehringer Ingelheim Investigational Site
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Kawagchi, Japan
- Boehringer Ingelheim Investigational Site
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Kawaguchi, Japan
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japan
- Boehringer Ingelheim Investigational Site 1
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Kawasaki, Japan
- Boehringer Ingelheim Investigational Site 2
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Kitakami, Japan
- Boehringer Ingelheim Investigational Site
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Kiyose, Japan
- Boehringer Ingelheim Investigational Site 1
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Kiyose, Japan
- Boehringer Ingelheim Investigational Site 2
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Kodaira, Japan
- Boehringer Ingelheim Investigational Site
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Kofu, Japan
- Boehringer Ingelheim Investigational Site
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Koga, Japan
- Boehringer Ingelheim Investigational Site
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Komae, Japan
- Boehringer Ingelheim Investigational Site
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Komatsu, Japan
- Boehringer Ingelheim Investigational Site
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Komatsushima, Japan
- Boehringer Ingelheim Investigational Site
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Koriyama, Japan
- Boehringer Ingelheim Investigational Site 1
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Koriyama, Japan
- Boehringer Ingelheim Investigational Site 2
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Koshigaya, Japan
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japan
- Boehringer Ingelheim Investigational Site 1
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Kumamoto, Japan
- Boehringer Ingelheim Investigational Site 2
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Kumamoto, Japan
- Boehringer Ingelheim Investigational Site 3
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Kure, Japan
- Boehringer Ingelheim Investigational Site
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Kusatsu, Japan
- Boehringer Ingelheim Investigational Site
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site 1
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site 2
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site 3
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site 4
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Maebashi, Japan
- Boehringer Ingelheim Investigational Site
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Matsudo, Japan
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japan
- Boehringer Ingelheim Investigational Site
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Mibu, Japan
- Boehringer Ingelheim Investigational Site
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Mihara, Japan
- Boehringer Ingelheim Investigational Site
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Mihoro, Japan
- Boehringer Ingelheim Investigational Site
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Miriyama, Japan
- Boehringer Ingelheim Investigational Site
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Misato, Japan
- Boehringer Ingelheim Investigational Site
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Miyako, Japan
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japan
- Boehringer Ingelheim Investigational Site 1
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Miyazaki, Japan
- Boehringer Ingelheim Investigational Site 2
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Moriguchi, Japan
- Boehringer Ingelheim Investigational Site
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Morioka, Japan
- Boehringer Ingelheim Investigational Site 1
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Morioka, Japan
- Boehringer Ingelheim Investigational Site 2
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Moriya, Japan
- Boehringer Ingelheim Investigational Site
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Musashino, Japan
- Boehringer Ingelheim Investigational Site
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Nagano, Japan
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japan
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, Japan
- Boehringer Ingelheim Investigational Site
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Nagoya, Japan
- Boehringer Ingelheim Investigational Site 1
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Nagoya, Japan
- Boehringer Ingelheim Investigational Site 2
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Nagoya, Japan
- Boehringer Ingelheim Investigational Site 3
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Nagoya, Japan
- Boehringer Ingelheim Investigational Site 4
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Nara, Japan
- Boehringer Ingelheim Investigational Site 1
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Nara, Japan
- Boehringer Ingelheim Investigational Site 2
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Narashino, Japan
- Boehringer Ingelheim Investigational Site
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Narita, Japan
- Boehringer Ingelheim Investigational Site
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Naruto, Japan
- Boehringer Ingelheim Investigational Site
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Nasushiobara, Japan
- Boehringer Ingelheim Investigational Site
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Nichinan, Japan
- Boehringer Ingelheim Investigational Site
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Ninohe, Japan
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japan
- Boehringer Ingelheim Investigational Site
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Ogaki, Japan
- Boehringer Ingelheim Investigational Site
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Oiso, Japan
- Boehringer Ingelheim Investigational Site
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Oita, Japan
- Boehringer Ingelheim Investigational Site 1
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Oita, Japan
- Boehringer Ingelheim Investigational Site 2
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Oita, Japan
- Boehringer Ingelheim Investigational Site 3
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Okaya, Japan
- Boehringer Ingelheim Investigational Site
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Okayama, Japan
- Boehringer Ingelheim Investigational Site 1
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Okayama, Japan
- Boehringer Ingelheim Investigational Site 2
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Okazaki, Japan
- Boehringer Ingelheim Investigational Site
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Okinawa, Japan
- Boehringer Ingelheim Investigational Site
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Omura, Japan
- Boehringer Ingelheim Investigational Site
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Omuta, Japan
- Boehringer Ingelheim Investigational Site
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Onojyo, Japan
- Boehringer Ingelheim Investigational Site
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 1
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 2
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 3
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 4
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 5
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Osaka, Japan
- Boehringer Ingelheim Investigational Site 6
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Ota, Japan
- Boehringer Ingelheim Investigational Site
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Otake, Japan
- Boehringer Ingelheim Investigational Site
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Otsu, Japan
- Boehringer Ingelheim Investigational Site
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Ryugasaki, Japan
- Boehringer Ingelheim Investigational Site
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Saeki, Japan
- Boehringer Ingelheim Investigational Site
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Saga, Japan
- Boehringer Ingelheim Investigational Site
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Sagamihara, Japan
- Boehringer Ingelheim Investigational Site 1
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Sagamihara, Japan
- Boehringer Ingelheim Investigational Site 2
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Sagamihara, Japan
- Boehringer Ingelheim Investigational Site 3
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Saijyo, Japan
- Boehringer Ingelheim Investigational Site
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Saitama, Japan
- Boehringer Ingelheim Investigational Site
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Sakai, Japan
- Boehringer Ingelheim Investigational Site 1
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Sakai, Japan
- Boehringer Ingelheim Investigational Site 2
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 3
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 4
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 5
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 6
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 8
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 9
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 7
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 1
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site 2
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Sekigahara, Japan
- Boehringer Ingelheim Investigational Site
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Sendai, Japan
- Boehringer Ingelheim Investigational Site 1
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Sendai, Japan
- Boehringer Ingelheim Investigational Site 2
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Shimoda, Japan
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japan
- Boehringer Ingelheim Investigational Site 1
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Shimotsuke, Japan
- Boehringer Ingelheim Investigational Site 2
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Shinngu, Japan
- Boehringer Ingelheim Investigational Site
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Shiroishi, Japan
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japan
- Boehringer Ingelheim Investigational Site 1
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Shizuoka, Japan
- Boehringer Ingelheim Investigational Site 2
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Showajima, Japan
- Boehringer Ingelheim Investigational Site
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Suita, Japan
- Boehringer Ingelheim Investigational Site 1
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Suita, Japan
- Boehringer Ingelheim Investigational Site 2
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Susono, Japan
- Boehringer Ingelheim Investigational Site
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Suzuka, Japan
- Boehringer Ingelheim Investigational Site
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Takaoka, Japan
- Boehringer Ingelheim Investigational Site 1
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Takaoka, Japan
- Boehringer Ingelheim Investigational Site 2
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Takatsuki, Japan
- Boehringer Ingelheim Investigational Site
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Tarimizu, Japan
- Boehringer Ingelheim Investigational Site
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Togitsu, Japan
- Boehringer Ingelheim Investigational Site
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Tokoname, Japan
- Boehringer Ingelheim Investigational Site
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Tokushima, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Arakawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Chuo-ku, Japan
- Boehringer Ingelheim Investigational Site 1
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Tokyo Chuo-ku, Japan
- Boehringer Ingelheim Investigational Site 2
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Tokyo Daito-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Koto-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, Japan
- Boehringer Ingelheim Investigational Site 1
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Tokyo Meguro-ku, Japan
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japan
- Boehringer Ingelheim Investigational Site 1
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Tokyo Minato-ku, Japan
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japan
- Boehringer Ingelheim Investigational Site 3
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Tokyo Nakano-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japan
- Boehringer Ingelheim Investigational Site 1
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Tokyo Ota-ku, Japan
- Boehringer Ingelheim Investigational Site 2
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Tokyo Setagaya, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shibuya-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjyuku-ku, Japan
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku, Japan
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku, Japan
- Boehringer Ingelheim Investigational Site 3
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Tokyo Sibuya-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo-Edogawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo-Itabashi-ku, Japan
- Boehringer Ingelheim Investigational Site
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Toride, Japan
- Boehringer Ingelheim Investigational Site
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Tosu, Japan
- Boehringer Ingelheim Investigational Site
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Toyama, Japan
- Boehringer Ingelheim Investigational Site 1
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Toyama, Japan
- Boehringer Ingelheim Investigational Site 2
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Toyama, Japan
- Boehringer Ingelheim Investigational Site 3
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Toyohashi, Japan
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japan
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japan
- Boehringer Ingelheim Investigational Site
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Ube, Japan
- Boehringer Ingelheim Investigational Site
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Uchinada, Japan
- Boehringer Ingelheim Investigational Site
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Ueda, Japan
- Boehringer Ingelheim Investigational Site
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Ushiku, Japan
- Boehringer Ingelheim Investigational Site
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Utsunomiya, Japan
- Boehringer Ingelheim Investigational Site 1
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Utsunomiya, Japan
- Boehringer Ingelheim Investigational Site 2
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Wakayama, Japan
- Boehringer Ingelheim Investigational Site
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Yachiyo, Japan
- Boehringer Ingelheim Investigational Site 1
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Yachiyo, Japan
- Boehringer Ingelheim Investigational Site 2
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Yachiyo, Japan
- Boehringer Ingelheim Investigational Site 3
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Yamanashi, Japan
- Boehringer Ingelheim Investigational Site
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Yanago, Japan
- Boehringer Ingelheim Investigational Site
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Yoichi, Japan
- Boehringer Ingelheim Investigational Site
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site 1
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site 2
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site 3
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site 4
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Yokosuka, Japan
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japan
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Global Impression of Improvement
Time Frame: 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
Time Frame: Baseline and after 12 weeks (or at the time of discontinuation)
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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
Time Frame: 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
Time Frame: 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
Time Frame: After 12 weeks or at the time of discontinuation
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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.
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After 12 weeks or at the time of discontinuation
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248.635
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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