- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622303
Depression, Anxiety and Sleep in Parkinson's Disease
Assessment of Depression , Anxiety and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015).
Age ≥ 50 years. Ability to understand and respond to questionnaires and rating scales. Ability and willingness to provide informed consent.
Exclusion Criteria:
Patients with atypical parkinsonism. Patients with a history of other major neurological disorders (e.g., stroke, Alzheimer's disease, multiple sclerosis).
Patients with severe cognitive impairment or dementia that prevents reliable completion of rating scales.
Patients with a current diagnosis of severe psychiatric disorders unrelated to Parkinson's disease (e.g., schizophrenia, bipolar disorder).
Patients with unstable medical conditions. Patients unable or unwilling to provide informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease
Time Frame: Baseline assessment during study enrollment.
|
Depression severity measured using the Hamilton Depression Rating Scale (HAM-D).
Scores range from 0 to 52, with higher scores indicating more severe depression.
|
Baseline assessment during study enrollment.
|
|
Assessment of Anxiety Severity in Patients with idiopathic Parkinson's Disease
Time Frame: Baseline
|
Anxiety severity measured using the Hamilton Anxiety Rating Scale (HAM-A).
Scores range from 0 to 56, with higher scores indicating more severe anxiety.
|
Baseline
|
|
Assessment of Sleep Disturbance in Patients with idiopathic Parkinson's Disease
Time Frame: Baseline
|
Sleep disturbance measured using the Parkinson's Disease Sleep Scale (PDSS).
Higher scores indicate better sleep quality and fewer sleep-related symptoms.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-5-4MS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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