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Completed

NCT Number: NCT00614575

Survey on PD 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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Akashi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events

    Time frame: for 12 weeks

    The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.

Secondary outcomes

  1. Clinical Global Impression of Improvement

    Time frame: for 12 weeks after initiation of the treatment

    Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).

  2. 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)

    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.

  3. 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)

    The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.

  4. 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)

    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.

  5. Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale

    Time frame: After 12 weeks or at the time of discontinuation

    This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Important dates

Study start
2007
Primary completion
2009
First posted
Feb 13, 2008
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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