- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07622303
Depression, Anxiety and Sleep in Parkinson's Disease
Assessment of Depression , Anxiety and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Sleep disturbance measured using the Parkinson's Disease Sleep Scale (PDSS).
Higher scores indicate better sleep quality and fewer sleep-related symptoms.
|
Baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Soh-Med-26-5-4MS
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