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Trial registered on ANZCTR


Registration number
ACTRN12611000490976
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
10/05/2011
Date last updated
11/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Obsessive Compulsive Spectrum Disorders and Quality of Life in patients with Idiopathic Parkinson's Disease
Scientific title
Obsessive Compulsive Spectrum Disorders and Quality of Life in patients with Idiopathic Parkinson's Disease
Secondary ID [1] 259944 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 265562 0
Obsessive Compulsive Spectrum Disorders 265563 0
Condition category
Condition code
Neurological 265710 265710 0 0
Parkinson's disease
Mental Health 265711 265711 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with diagnosed with Idiopathic Parkinson's Disease

Patients will undergo a Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MOCA), Quality of Life (QoL) using the Parkinson’s disease Questionnaire (PDQ-39), and Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s disease (QUIP-Anytime During Parkinson’s disease-Full). A neurologist will assess the patients Parkinson’s disease and staging using the Unified Parkinson’s disease Rating Scale (UPDRS), as well as co morbidities and medication use. A psychiatrist will interview the patient for Obsessive-Compulsive Disorder Related/Spectrum Disorders (Obsessive-Compulsive-Spectrum Disorders) using the Expanded Structured Clinical Interview for DSM-IV–TR.

Patients will be recruited over a 26 month period
Intervention code [1] 264355 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266475 0
The quality of life of Parkinson's patients assessed by The Parkinson's Disease Questionnaire (PDQ-39).
Timepoint [1] 266475 0
During Visit
Secondary outcome [1] 273849 0
% of Parkinson's patients diagnosed with Obsessive Compulsive Spectrum Disorders (OCSD).

Patients will be diagnosed by psychiatrist using the Mini International Neuropsychiatric Interview (MINI).
Timepoint [1] 273849 0
During Visit

Eligibility
Key inclusion criteria
Patient's diagnosed with Idiopathic Parkinson's Disease
Minimum age
30 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients diagnosed with schizophrenia or bipolar disorders

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3897 0
2747

Funding & Sponsors
Funding source category [1] 264823 0
Charities/Societies/Foundations
Name [1] 264823 0
Parkinson's New South Wales Inc
Address [1] 264823 0
PO Box 71
NORTH RYDE BC NSW 1670
Country [1] 264823 0
Australia
Funding source category [2] 264939 0
Charities/Societies/Foundations
Name [2] 264939 0
Nepean Medical Research Foundation
Address [2] 264939 0
PO Box 82
EMU PLAINS NSW 2750
Country [2] 264939 0
Australia
Primary sponsor type
Individual
Name
Martin Krause
Address
Nepean Hospital
Level 5 South Block
PO Box 63
PENRITH NSW 2751
Country
Australia
Secondary sponsor category [1] 264037 0
None
Name [1] 264037 0
Address [1] 264037 0
Country [1] 264037 0
Other collaborator category [1] 251930 0
Individual
Name [1] 251930 0
Victor Fung
Address [1] 251930 0
Westmead Hospital
PO BOX 533
WENTWORTHVILLE NSW 2145
Country [1] 251930 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266789 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 266789 0
Research Office, Court Building
PO BOX 63
PENRITH NSW2751
Ethics committee country [1] 266789 0
Australia
Date submitted for ethics approval [1] 266789 0
Approval date [1] 266789 0
11/06/2008
Ethics approval number [1] 266789 0
08/026/08/NEPEAN/41

Summary
Brief summary
Parkinson’s disease primarily affects the way a person is able to move or walk and causes muscle stiffness and tremor, which can be very disabling. However, these patients also suffer from non-motor symptoms. These non-motor symptoms include depression, cognitive impairment, and sleep disturbances. As the disease progresses these non-motor symptoms have been shown to have a greater impact on the patients quality of life (QoL).

Obsessive Compulsive Spectrum Disorders (OCSD) are a group of psychiatric disorders that have been demonstrated in patient with Parkinson’s disease.

We hypothesized that OCSD have an impact on the QoL of patient’s with idiopathic disease. We aim evaluate the prevalence OCSD in patients with idiopathic Parkinson’s disease and its impact on the patient’s QoL.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32448 0
Address 32448 0
Country 32448 0
Phone 32448 0
Fax 32448 0
Email 32448 0
Contact person for public queries
Name 15695 0
Martin Krause
Address 15695 0
Nepean Hospital
Level 5, South Block
PO BOX 63
PENRITH NSW 2751
Country 15695 0
Australia
Phone 15695 0
+61 2 4734 4278
Fax 15695 0
+61 2 4734 1817
Email 15695 0
martin.krause@sydney.edu.au
Contact person for scientific queries
Name 6623 0
Martin Krause
Address 6623 0
Nepean Hospital
Level 5, South Block
PO BOX 63
PENRITH NSW 2751
Country 6623 0
Australia
Phone 6623 0
+61 2 4734 4278
Fax 6623 0
+61 2 4734 1817
Email 6623 0
martin.krause@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary