NCT07622303

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026May 2027

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 24, 2026

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease

    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

    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

    Sleep disturbance measured using the Parkinson's Disease Sleep Scale (PDSS). Higher scores indicate better sleep quality and fewer sleep-related symptoms.

    Baseline

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • Patients with unstable medical conditions. 7-Patients unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurology Resident

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 3, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-05