Non-Motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

This study has been completed.

First Received: March 31, 2008 Last Updated: July 15, 2008 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00651183

Purpose

The objective of this PMS study is the evaluation of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADSD under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson?s disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).

Condition	Intervention	Phase
Parkinson Disease	Drug: Pramipexole immediate release	Phase IV

Study Type:	Observational
Official Title:	Non-Motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

effect of pramipexole on depressive symptoms in early and advanced PD patients course of depressive symptoms measured with UPDRS Part I and HADSD Evaluation whether improvement of depressive symptoms is linked to improvement in motor function

Estimated Enrollment:	250
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Idiopathic PD with or without fluctuations
Indication for treatment with Pramipexole
Presence of at least mild depressive symptoms (as judged by the treating physician)
Ability to reliably complete a selfrating scale (HADS)

EXCLUSION CRITERIA:

Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
Ongoing treatment with pramipexole

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651183

Show 57 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	248.649
Study First Received:	March 31, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00651183 History of Changes
Health Authority:	Austria: Bundesamt für Sicherheit im Gesundheitswesen; United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Ganglion Cysts
Antioxidants
Basal Ganglia Diseases
Central Nervous System Diseases
Dopamine Agonists
Depressive Disorder
Brain Diseases

Neurodegenerative Diseases
Pramipexol
Behavioral Symptoms
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Depression
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Protective Agents
Pharmacologic Actions
Pramipexol
Behavioral Symptoms
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009