Clinical trial NCT00614575: Survey on PD Patients With Depressive Symptoms
Official title: BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 1089
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients with depressive symptoms

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
timeFrame: for 12 weeks
Secondary outcomes:
measure: Clinical Global Impression of Improvement
timeFrame: for 12 weeks after initiation of the treatment
measure: Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
timeFrame: Baseline and after 12 weeks (or at the time of discontinuation)
measure: Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
timeFrame: Baseline and after 12 weeks (or at the time of discontinuation)
measure: Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
timeFrame: Baseline and after 12 weeks (or at the time of discontinuation)
measure: Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
timeFrame: After 12 weeks or at the time of discontinuation
Other outcomes:
Locations:
city: Akashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Akita
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ashikaga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Awaji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Chitose
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Chuo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fuchu
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Fuchu
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Fuefuki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fuehuki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fujioka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fujisaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fujisawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Funabashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Habikino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hachioji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Hanamaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hayashima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Higashiosaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Higashiosaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Himeji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hirakata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hirishima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hirosaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ibaragi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iizuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Inag
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Irima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Isahaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iwaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iwamizawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iwata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Jyoetsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Jyoetsu
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Jyoyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Kahoku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kamakura
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kanazawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kanazawa
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kanoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kanoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kashihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kashihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kasuga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawagchi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kitakami
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kiyose
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kiyose
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kodaira
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kofu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komae
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komatsushima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Koriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Koshigaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Kure
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kusatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Maebashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsudo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mibu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mihara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mihoro
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Misato
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miyako
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Moriguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Moriya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Musashino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagano
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagaokakyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagaoka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Narashino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Nara
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Narita
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Naruto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nasushiobara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nichinan
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ninohe
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nishinomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nishitokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ogaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Oiso
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Okaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Omura
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Omuta
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Onojyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Otake
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ota
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Otsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ryugasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saeki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Saga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saijyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 5
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 6
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 7
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 8
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site 9
city: Sekigahara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Shimoda
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Shinngu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shiroishi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Showajima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Suita
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Suita
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Susono
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Suzuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Takaoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Takaoka
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tarimizu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Togitsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokoname
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokushima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Arakawa-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Bunkyo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Chuo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Tokyo Chuo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Tokyo Daito-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Koto-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Meguro-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Tokyo Meguro-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Tokyo Minato-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Tokyo Minato-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Tokyo Minato-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Tokyo Nakano-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Nerima-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Ota-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Tokyo Ota-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Tokyo Setagaya-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Setagaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shibuya-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shinagawa-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shinjyuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Tokyo Shinjyuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Tokyo Shinjyuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Tokyo Sibuya-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Toshima-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo-Edogawa-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo-Itabashi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toride
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tosu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Toyama
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Toyohashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toyokawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toyonaka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ube
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Uchinada
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ueda
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ushiku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Utsunomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Utsunomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yachiyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Yachiyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Yachiyo
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Yamanashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yanago
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yoichi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 1
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 2
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 3
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site 4
city: Yokosuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yoshinogawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: