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)
1 other identifier
observational
1,089
1 country
238
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
238 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
July 19, 2011
CompletedAugust 6, 2014
August 1, 2014
2.6 years
January 31, 2008
February 23, 2011
August 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
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
Secondary Outcomes (5)
Clinical Global Impression of Improvement
for 12 weeks after initiation of the treatment
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
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
Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
After 12 weeks or at the time of discontinuation
Study Arms (1)
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy
Eligibility Criteria
PD patients with depressive symptoms
You may qualify if:
- \*\*PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (238)
Boehringer Ingelheim Investigational Site
Akashi, Japan
Boehringer Ingelheim Investigational Site 1
Akita, Japan
Boehringer Ingelheim Investigational Site 2
Akita, Japan
Boehringer Ingelheim Investigational Site
Asahikawa, Japan
Boehringer Ingelheim Investigational Site
Ashikaga, Japan
Boehringer Ingelheim Investigational Site
Awaji, Japan
Boehringer Ingelheim Investigational Site
Chitose, Japan
Boehringer Ingelheim Investigational Site
Chūō, Japan
Boehringer Ingelheim Investigational Site 1
Fuchū, Japan
Boehringer Ingelheim Investigational Site 2
Fuchū, Japan
Boehringer Ingelheim Investigational Site
Fuefuki, Japan
Boehringer Ingelheim Investigational Site
Fuehuki, Japan
Boehringer Ingelheim Investigational Site
Fujioka, Japan
Boehringer Ingelheim Investigational Site
Fujisaki, Japan
Boehringer Ingelheim Investigational Site
Fujisawa, Japan
Boehringer Ingelheim Investigational Site
Fukaya, Japan
Boehringer Ingelheim Investigational Site 1
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 2
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 3
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 4
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 5
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 1
Fukushima, Japan
Boehringer Ingelheim Investigational Site 2
Fukushima, Japan
Boehringer Ingelheim Investigational Site
Funabashi, Japan
Boehringer Ingelheim Investigational Site 1
Gifu, Japan
Boehringer Ingelheim Investigational Site 2
Gifu, Japan
Boehringer Ingelheim Investigational Site
Habikino, Japan
Boehringer Ingelheim Investigational Site
Hachiōji, Japan
Boehringer Ingelheim Investigational Site 1
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 2
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 3
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 4
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 5
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site
Hanamaki, Japan
Boehringer Ingelheim Investigational Site
Hayashima, Japan
Boehringer Ingelheim Investigational Site 1
Higashiosaka, Japan
Boehringer Ingelheim Investigational Site 2
Higashiosaka, Japan
Boehringer Ingelheim Investigational Site
Himeji, Japan
Boehringer Ingelheim Investigational Site
Hirakata, Japan
Boehringer Ingelheim Investigational Site
Hirishima, Japan
Boehringer Ingelheim Investigational Site
Hirosaki, Japan
Boehringer Ingelheim Investigational Site
Ibaraki, Japan
Boehringer Ingelheim Investigational Site
Iizuka, Japan
Boehringer Ingelheim Investigational Site
Inag, Japan
Boehringer Ingelheim Investigational Site
Irima, Japan
Boehringer Ingelheim Investigational Site
Isahaya, Japan
Boehringer Ingelheim Investigational Site
Iwaki, Japan
Boehringer Ingelheim Investigational Site
Iwamizawa, Japan
Boehringer Ingelheim Investigational Site
Iwata, Japan
Boehringer Ingelheim Investigational Site 1
Jyoetsu, Japan
Boehringer Ingelheim Investigational Site 2
Jyoetsu, Japan
Boehringer Ingelheim Investigational Site
Jyoyo, Japan
Boehringer Ingelheim Investigational Site 1
Kagoshima, Japan
Boehringer Ingelheim Investigational Site 2
Kagoshima, Japan
Boehringer Ingelheim Investigational Site 3
Kagoshima, Japan
Boehringer Ingelheim Investigational Site
Kahoku, Japan
Boehringer Ingelheim Investigational Site
Kamakura, Japan
Boehringer Ingelheim Investigational Site 1
Kanazawa, Japan
Boehringer Ingelheim Investigational Site 2
Kanazawa, Japan
Boehringer Ingelheim Investigational Site 1
Kanoya, Japan
Boehringer Ingelheim Investigational Site 2
Kanoya, Japan
Boehringer Ingelheim Investigational Site 1
Kashihara, Japan
Boehringer Ingelheim Investigational Site 2
Kashihara, Japan
Boehringer Ingelheim Investigational Site
Kasuga, Japan
Boehringer Ingelheim Investigational Site
Kawagchi, Japan
Boehringer Ingelheim Investigational Site
Kawaguchi, Japan
Boehringer Ingelheim Investigational Site 1
Kawasaki, Japan
Boehringer Ingelheim Investigational Site 2
Kawasaki, Japan
Boehringer Ingelheim Investigational Site
Kitakami, Japan
Boehringer Ingelheim Investigational Site 1
Kiyose, Japan
Boehringer Ingelheim Investigational Site 2
Kiyose, Japan
Boehringer Ingelheim Investigational Site
Kodaira, Japan
Boehringer Ingelheim Investigational Site
Kofu, Japan
Boehringer Ingelheim Investigational Site
Koga, Japan
Boehringer Ingelheim Investigational Site
Komae, Japan
Boehringer Ingelheim Investigational Site
Komatsu, Japan
Boehringer Ingelheim Investigational Site
Komatsushima, Japan
Boehringer Ingelheim Investigational Site
Koshigaya, Japan
Boehringer Ingelheim Investigational Site 1
Kōriyama, Japan
Boehringer Ingelheim Investigational Site 2
Kōriyama, Japan
Boehringer Ingelheim Investigational Site
Kōtari, Japan
Boehringer Ingelheim Investigational Site 1
Kumamoto, Japan
Boehringer Ingelheim Investigational Site 2
Kumamoto, Japan
Boehringer Ingelheim Investigational Site 3
Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Kure, Japan
Boehringer Ingelheim Investigational Site
Kusatsu, Japan
Boehringer Ingelheim Investigational Site 1
Kyoto, Japan
Boehringer Ingelheim Investigational Site 2
Kyoto, Japan
Boehringer Ingelheim Investigational Site 3
Kyoto, Japan
Boehringer Ingelheim Investigational Site 4
Kyoto, Japan
Boehringer Ingelheim Investigational Site
Maebashi, Japan
Boehringer Ingelheim Investigational Site
Matsudo, Japan
Boehringer Ingelheim Investigational Site
Matsumoto, Japan
Boehringer Ingelheim Investigational Site
Mibu, Japan
Boehringer Ingelheim Investigational Site
Mihara, Japan
Boehringer Ingelheim Investigational Site
Mihoro, Japan
Boehringer Ingelheim Investigational Site
Miriyama, Japan
Boehringer Ingelheim Investigational Site
Misato, Japan
Boehringer Ingelheim Investigational Site
Miyako, Japan
Boehringer Ingelheim Investigational Site 1
Miyazaki, Japan
Boehringer Ingelheim Investigational Site 2
Miyazaki, Japan
Boehringer Ingelheim Investigational Site
Moriguchi, Japan
Boehringer Ingelheim Investigational Site 1
Morioka, Japan
Boehringer Ingelheim Investigational Site 2
Morioka, Japan
Boehringer Ingelheim Investigational Site
Moriya, Japan
Boehringer Ingelheim Investigational Site
Mukai-awagasaki, Japan
Boehringer Ingelheim Investigational Site
Musashino, Japan
Boehringer Ingelheim Investigational Site
Nagano, Japan
Boehringer Ingelheim Investigational Site
Nagaoka, Japan
Boehringer Ingelheim Investigational Site 1
Nagoya, Japan
Boehringer Ingelheim Investigational Site 2
Nagoya, Japan
Boehringer Ingelheim Investigational Site 3
Nagoya, Japan
Boehringer Ingelheim Investigational Site 4
Nagoya, Japan
Boehringer Ingelheim Investigational Site 1
Nara, Japan
Boehringer Ingelheim Investigational Site 2
Nara, Japan
Boehringer Ingelheim Investigational Site
Narashino, Japan
Boehringer Ingelheim Investigational Site
Narita, Japan
Boehringer Ingelheim Investigational Site
Narutō, Japan
Boehringer Ingelheim Investigational Site
Nasushiobara, Japan
Boehringer Ingelheim Investigational Site
Nichinan, Japan
Boehringer Ingelheim Investigational Site
Ninohe, Japan
Boehringer Ingelheim Investigational Site
Nishinomiya, Japan
Boehringer Ingelheim Investigational Site
Nishitōkyō, Japan
Boehringer Ingelheim Investigational Site
Okaya, Japan
Boehringer Ingelheim Investigational Site 1
Okayama, Japan
Boehringer Ingelheim Investigational Site 2
Okayama, Japan
Boehringer Ingelheim Investigational Site
Okazaki, Japan
Boehringer Ingelheim Investigational Site
Okinawa, Japan
Boehringer Ingelheim Investigational Site
Omuta, Japan
Boehringer Ingelheim Investigational Site 1
Osaka, Japan
Boehringer Ingelheim Investigational Site 2
Osaka, Japan
Boehringer Ingelheim Investigational Site 3
Osaka, Japan
Boehringer Ingelheim Investigational Site 4
Osaka, Japan
Boehringer Ingelheim Investigational Site 5
Osaka, Japan
Boehringer Ingelheim Investigational Site 6
Osaka, Japan
Boehringer Ingelheim Investigational Site
Ōgaki, Japan
Boehringer Ingelheim Investigational Site
Ōiso, Japan
Boehringer Ingelheim Investigational Site 1
Ōita, Japan
Boehringer Ingelheim Investigational Site 2
Ōita, Japan
Boehringer Ingelheim Investigational Site 3
Ōita, Japan
Boehringer Ingelheim Investigational Site
Ōmura, Japan
Boehringer Ingelheim Investigational Site
Ōnojō, Japan
Boehringer Ingelheim Investigational Site
Ōta-ku, Japan
Boehringer Ingelheim Investigational Site
Ōtake, Japan
Boehringer Ingelheim Investigational Site
Ōtsu, Japan
Boehringer Ingelheim Investigational Site
Ryūgasaki, Japan
Boehringer Ingelheim Investigational Site
Saeki, Japan
Boehringer Ingelheim Investigational Site
Saga, Japan
Boehringer Ingelheim Investigational Site 1
Sagamihara, Japan
Boehringer Ingelheim Investigational Site 2
Sagamihara, Japan
Boehringer Ingelheim Investigational Site 3
Sagamihara, Japan
Boehringer Ingelheim Investigational Site
Saijyo, Japan
Boehringer Ingelheim Investigational Site
Saitama, Japan
Boehringer Ingelheim Investigational Site 1
Sakai, Japan
Boehringer Ingelheim Investigational Site 2
Sakai, Japan
Boehringer Ingelheim Investigational Site 1
Sapporo, Japan
Boehringer Ingelheim Investigational Site 2
Sapporo, Japan
Boehringer Ingelheim Investigational Site 3
Sapporo, Japan
Boehringer Ingelheim Investigational Site 4
Sapporo, Japan
Boehringer Ingelheim Investigational Site 5
Sapporo, Japan
Boehringer Ingelheim Investigational Site 6
Sapporo, Japan
Boehringer Ingelheim Investigational Site 7
Sapporo, Japan
Boehringer Ingelheim Investigational Site 8
Sapporo, Japan
Boehringer Ingelheim Investigational Site 9
Sapporo, Japan
Boehringer Ingelheim Investigational Site
Sekigahara, Japan
Boehringer Ingelheim Investigational Site 1
Sendai, Japan
Boehringer Ingelheim Investigational Site 2
Sendai, Japan
Boehringer Ingelheim Investigational Site
Shimoda, Japan
Boehringer Ingelheim Investigational Site 1
Shimotsuke, Japan
Boehringer Ingelheim Investigational Site 2
Shimotsuke, Japan
Boehringer Ingelheim Investigational Site
Shinngu, Japan
Boehringer Ingelheim Investigational Site
Shiroishi, Japan
Boehringer Ingelheim Investigational Site 1
Shizuoka, Japan
Boehringer Ingelheim Investigational Site 2
Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Shōwajima, Japan
Boehringer Ingelheim Investigational Site 1
Suita, Japan
Boehringer Ingelheim Investigational Site 2
Suita, Japan
Boehringer Ingelheim Investigational Site
Susono, Japan
Boehringer Ingelheim Investigational Site
Suzuka, Japan
Boehringer Ingelheim Investigational Site 1
Takaoka, Japan
Boehringer Ingelheim Investigational Site 2
Takaoka, Japan
Boehringer Ingelheim Investigational Site
Takatsuki, Japan
Boehringer Ingelheim Investigational Site
Tarimizu, Japan
Boehringer Ingelheim Investigational Site
Togitsu, Japan
Boehringer Ingelheim Investigational Site
Tokoname, Japan
Boehringer Ingelheim Investigational Site
Tokushima, Japan
Boehringer Ingelheim Investigational Site
Tokyo Arakawa-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 1
Tokyo Chuo-ku, Japan
Boehringer Ingelheim Investigational Site 2
Tokyo Chuo-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Daito-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Koto-ku, Japan
Boehringer Ingelheim Investigational Site 1
Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site 2
Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site 1
Tokyo Minato-ku, Japan
Boehringer Ingelheim Investigational Site 2
Tokyo Minato-ku, Japan
Boehringer Ingelheim Investigational Site 3
Tokyo Minato-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Nakano-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Nerima-ku, Japan
Boehringer Ingelheim Investigational Site 1
Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site 2
Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Setagaya, Japan
Boehringer Ingelheim Investigational Site
Tokyo Shibuya-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Shinagawa-ku, Japan
Boehringer Ingelheim Investigational Site 1
Tokyo Shinjyuku-ku, Japan
Boehringer Ingelheim Investigational Site 2
Tokyo Shinjyuku-ku, Japan
Boehringer Ingelheim Investigational Site 3
Tokyo Shinjyuku-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Sibuya-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Toshima-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo-Edogawa-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo-Itabashi-ku, Japan
Boehringer Ingelheim Investigational Site
Toride, Japan
Boehringer Ingelheim Investigational Site
Tosu, Japan
Boehringer Ingelheim Investigational Site 1
Toyama, Japan
Boehringer Ingelheim Investigational Site 2
Toyama, Japan
Boehringer Ingelheim Investigational Site 3
Toyama, Japan
Boehringer Ingelheim Investigational Site
Toyohashi, Japan
Boehringer Ingelheim Investigational Site
Toyokawa, Japan
Boehringer Ingelheim Investigational Site
Toyonaka, Japan
Boehringer Ingelheim Investigational Site
Ube, Japan
Boehringer Ingelheim Investigational Site
Ueda, Japan
Boehringer Ingelheim Investigational Site
Ushiku, Japan
Boehringer Ingelheim Investigational Site 1
Utsunomiya, Japan
Boehringer Ingelheim Investigational Site 2
Utsunomiya, Japan
Boehringer Ingelheim Investigational Site
Wakayama, Japan
Boehringer Ingelheim Investigational Site 1
Yachiyo, Japan
Boehringer Ingelheim Investigational Site 2
Yachiyo, Japan
Boehringer Ingelheim Investigational Site 3
Yachiyo, Japan
Boehringer Ingelheim Investigational Site
Yamanashi, Japan
Boehringer Ingelheim Investigational Site
Yanago, Japan
Boehringer Ingelheim Investigational Site
Yoichi, Japan
Boehringer Ingelheim Investigational Site 1
Yokohama, Japan
Boehringer Ingelheim Investigational Site 2
Yokohama, Japan
Boehringer Ingelheim Investigational Site 3
Yokohama, Japan
Boehringer Ingelheim Investigational Site 4
Yokohama, Japan
Boehringer Ingelheim Investigational Site
Yokosuka, Japan
Boehringer Ingelheim Investigational Site
Yoshinogawa, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
January 1, 2007
Primary Completion
August 1, 2009
Last Updated
August 6, 2014
Results First Posted
July 19, 2011
Record last verified: 2014-08