Examining anxiety and depressive features in people with Parkinson’s disease
| ISRCTN | ISRCTN10000341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10000341 |
| IRAS number | 279691 |
| Secondary identifying numbers | CPMS 48056, Grant Codes: 848002, IRAS 279691 |
- Submission date
- 23/04/2021
- Registration date
- 06/12/2021
- Last edited
- 17/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Approximately 40% of people with Parkinson’s disease experience comorbid anxiety or depression, which are strong predictors of quality of life in Parkinson’s. Little is known about how anxiety or depression develops in Parkinson’s disease, and why some people with Parkinson’s disease are more prone to anxiety than others. Anxiety and depression are associated with increased symptom burden; however, this is poorly understood at present. There is little evidence on effective treatments for anxiety in Parkinson’s disease. The aim is to explore the aspects of emotional processing that are damaged in patients with Parkinson’s disease and Anxiety.
Who can participate?
Patients at different stages of Parkinson’s disease, ranging from early stages to advanced Parkinson’s disease.
What does the study involve?
4 visits (screening, baseline, 6-month follow-up and 12-month follow-up. Participants will answer questions on their anxiety, and undergo assessment of movement, cognition, and computerised behavioural tasks, and an optional MRI scan.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
March 2021 to July 2024
Who is funding the study?
The research costs for the study have been supported by EU Commission grant (Horizon2020 grant 848002)
Who is the main contact?
Ms Saghi Arabi, s.arabi@ucl.ac.uk
Contact information
Scientific
Room 2/690, Clinical Neurosciences Laboratories (Inst. of Neurology)
The Royal Free London NHS Foundation Trust
Rowland Hill St
London
NW3 2PF
United Kingdom
 ORCID ID |
0000-0002-8029-7865 |
|---|---|
| Phone | +44 (0)20 3108 5462 |
| s.arabi@ucl.ac.uk |
Study information
| Study design | Observational cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | See additional files |
| Scientific title | Anxiety and depression in Parkinson's Disease |
| Study acronym | AND-PD |
| Study hypothesis | The key objectives are to determine the risk factors and associated clinical features of anxiety and depression in Parkinson’s Disease, and to identify the underlying biological changes associated with emotional dysfunction in Parkinson’s Disease. The eventual aim will be to identify targets to design rational therapies for therapeutic trials to improve anxiety and depression in Parkinson’s disease. |
| Ethics approval(s) | Approved 12/03/2021, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8210; bradfordleeds.rec@hra.nhs.uk), REC ref: 21/YH/0016 |
| Condition | Anxiety and depression in Parkinson's Disease |
| Intervention | The study is an observational and longitudinal study. This design and methodology were chosen so that we could look at patients at different stages of Parkinson’s disease; ranging from early stages to advanced Parkinson’s disease. We will examine anxiety and depression in patients with PD, across disease stages, and subgroups. Healthy controls will be recruited to create an aged-matched group. The broad timetable for the stages of research are: preparation January 2020 - December 2020, assessments January 2021-December 2022, interpreting and analyzing data - 2023, preparing the final report, and disseminating results via conference presentations/peer-reviewed scientific journals (2024). All assessments will take place either remotely online or at the Royal Free Hospital Campus, UCL or at King's College Hospital, London. Currently, there are no planned interim analyses or reports. To compensate for any possible research effects or biases, the analyses will be performed by a researcher blind to group (single-blind). Visit 1: Baseline assessment will occur after enrolment in the study. Participants with Parkinson’s Disease will receive a combination of self-administered and/or researcher-administered scales to assess their clinical and cognitive symptoms online. Demographic data will be collected at baseline only. Assessments will take place either online or at one of the four NHS sites. Some questionnaires and assessments can be sent to the participant to be completed before the study day. The optional MRI scans will be carried out at Wellcome Centre for Human Neuroimaging, Queen Square, London or at the Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, London. The scans will be carried out by a radiographer and one of the researchers. Visit 2 (last visit): Participants with Parkinson’s will receive a combination of self-administered and/or researcher-administered scales to complete, assessing their clinical and cognitive symptoms. This will take place online or when it is safe to do so, at one either Royal Free Hospital Campus, UCL or at King's College Hospital, London. |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline, 6 and 12 months: 1. Anxiety measured using the Parkinson Anxiety Scale (PAS) 2. Depression measured using the Patient Health Questionnaire (PHQ-9) |
| Secondary outcome measures | Measured at baseline, 6 and 12 months: 1. Anxiety and depression measured using a visual analogue scale of anxiety and mood 2. Non-motor symptoms measured using the MDS Non-Motor Rating Scale (MDS-NMS) 3. Non-motor and motor experiences of daily living and motor complications using the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 4. Activation in the ROIs measured using fMRI BOLD |
| Overall study start date | 01/03/2021 |
| Overall study end date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 89 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350; UK Sample Size: 350 |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 01/07/2021 |
| Recruitment end date | 30/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
London
NW3 2QG
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
Luton
LU4 0DZ
United Kingdom
London
SE5 9RS
United Kingdom
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
Wolfson Centre, D1
Bath
BA1 3NG
United Kingdom
Truro
TR1 3HD
United Kingdom
Bangor
LL57 2PW
United Kingdom
Sponsor information
University/education
Joint Research Office, UCL
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 203 447 5696 |
|---|---|
| UCLH.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/07/2024: The following changes were made to the trial record:
1. The target number of participants was changed from Planned Sample Size: 200; UK Sample Size: 200 to Planned Sample Size: 350; UK Sample Size: 350.
2. The recruitment end date was changed from 31/12/2023 to 30/06/2024.
3. The study participating centre Lister Hospital was removed.
21/04/2023: NIHR Clinical Research Network North West, Royal United Hospital, Royal Cornwall Hospital and Gwynedd Hospital were added as trial participating centres.
20/04/2023: Contact details updated.
23/04/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
