- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622303
Depression, Anxiety and Sleep in Parkinson's Disease
June 5, 2026 updated by: Aya Noureldin Mohamed, Sohag University
Assessment of Depression , Anxiety and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
This study aims to assess the prevalence and severity of depression, anxiety, and sleep disorders among patients with idiopathic Parkinson's disease.
The study will evaluate the relationship between neuropsychiatric symptoms and disease characteristics in order to improve early recognition and patient quality of life.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients aged 50 years and older with idiopathic Parkinson's disease attending the Neurology Outpatient Clinic and/or admitted to the Neurology Department of Sohag University Hospital.
A total of 100 eligible patients will be recruited to assess depression, anxiety, and sleep disorders.
Description
A-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.
B-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 5-Parkinson's disease (e.g., schizophrenia, bipolar disorder).
6-Patients with unstable medical conditions. 7-Patients unable or unwilling to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
May 24, 2026
First Submitted That Met QC Criteria
May 30, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
May 1, 2026
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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