Survey on PD Patients With Depressive Symptoms

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00614575
First received: January 31, 2008
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events [ Time Frame: for 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impression of Improvement [ Time Frame: for 12 weeks after initiation of the treatment ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale [ Time Frame: After 12 weeks or at the time of discontinuation ] [ Designated as safety issue: No ]
    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.


Enrollment: 1089
Study Start Date: January 2007
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PD patients with depressive symptoms

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614575

  Hide Study Locations
Locations
Japan
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
Chuo, Japan
Boehringer Ingelheim Investigational Site 1
Fuchu, Japan
Boehringer Ingelheim Investigational Site 2
Fuchu, 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
Hachioji, 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
Ibaragi, 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 1
Koriyama, Japan
Boehringer Ingelheim Investigational Site 2
Koriyama, Japan
Boehringer Ingelheim Investigational Site
Koshigaya, 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
Musashino, Japan
Boehringer Ingelheim Investigational Site
Nagano, Japan
Boehringer Ingelheim Investigational Site
Nagaoka, Japan
Boehringer Ingelheim Investigational Site
Nagaokakyo, 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
Naruto, 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
Nishitokyo, Japan
Boehringer Ingelheim Investigational Site
Ogaki, Japan
Boehringer Ingelheim Investigational Site
Oiso, Japan
Boehringer Ingelheim Investigational Site 1
Oita, Japan
Boehringer Ingelheim Investigational Site 2
Oita, Japan
Boehringer Ingelheim Investigational Site 3
Oita, 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
Omura, Japan
Boehringer Ingelheim Investigational Site
Omuta, Japan
Boehringer Ingelheim Investigational Site
Onojyo, 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
Ota, Japan
Boehringer Ingelheim Investigational Site
Otake, Japan
Boehringer Ingelheim Investigational Site
Otsu, Japan
Boehringer Ingelheim Investigational Site
Ryugasaki, 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
Showajima, 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, Japan
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku, 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
Uchinada, 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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00614575     History of Changes
Other Study ID Numbers: 248.635
Study First Received: January 31, 2008
Results First Received: February 23, 2011
Last Updated: June 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Depression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014