Examining anxiety and depressive features in people with Parkinson’s disease

Not Applicable

Completed

• Conditions: Anxiety and depression in Parkinson's Disease; Mental and Behavioural Disorders

• Registration Number: ISRCTN10000341
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-06
• Study Completion: 2024-07-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Participants must be judged by the investigator to have capacity to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.
2. Willing and able to provide written consent
3. All participants must have adequate visual and auditory acuity according to investigator’s judgement to complete the neuropsychological testing.
4. People with PD should have confirmed diagnosis of PD according to Movement Disorder Society Clinical Diagnostic Criteria and must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
5. Aged 18 - 89 years
6. Can tolerate behavioural and psychological testing
7. Score of or above 14 on the PAS

Exclusion Criteria

General exclusion criteria
1. Past/present psychotic disorder, bipolar disorder/mania or alcohol/substance use disorder (outside a comorbid psychiatric episode) that would interfere in completing assessments or impair the safety of the participant.
2. History of medical illness that may impair cognitive function (e.g. serious head injury, endocrine disorder)
3. Atypical PD syndromes due to either drugs (e.g. metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g. Wilson’s disease), encephalitis, or degenerative diseases (e.g. progressive supranuclear palsy).
4. Previously obtained MRI scan with evidence of clinically significant other neurological disorder (in the opinion of the Investigator).

MRI exclusion criteria
5. MRI contraindications such as a pacemaker, aneurysm clip, cochlear implant, neurostimulator, IUD, shrapnel, metal fragments in the eye, a weight of above 250lbs or claustrophobia.
6. There are no exclusionary medications for this study.
7. Females who are pregnant, planning pregnancy, or breastfeeding.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at baseline, 6 and 12 months:<br>1. Anxiety measured using the Parkinson Anxiety Scale (PAS)<br>2. Depression measured using the Patient Health Questionnaire (PHQ-9)

Secondary Outcome Measures

Name	Time	Method
Measured at baseline, 6 and 12 months:<br>1. Anxiety and depression measured using a visual analogue scale of anxiety and mood<br>2. Non-motor symptoms measured using the MDS Non-Motor Rating Scale (MDS-NMS)<br>3. Non-motor and motor experiences of daily living and motor complications using the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)<br>4. Activation in the ROIs measured using fMRI BOLD