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ADepT-PD

ADepT-PD: A placebo-controlled trial of escitalopram and nortriptyline for depressive symptoms in Parkinson’s, and to examine the effectiveness of nortriptyline to delay motor progression

12 January 2022

adept

Funder: NIHR HTA
ISRCTN: ISRCTN48548553
ClinicalTrials.gov: NCT03652870
EudraCT: 2018-002942-35
REC: 19/LO/028

Trial Information

The key aims of the ADepT-PD and ADepT-PD motor progression are to 1) establish the effectiveness of nortriptyline vs escitalopram vs placebo for depressive symptoms in PD (currently largely underrecognised) and 2) to examine the potential effects of nortriptyline to delay motor progression of Parkinson’s itself.

Many different types of antidepressants are available to treat depression in Parkinson’s but which one is the most suitable and effective for people with Parkinson’s is currently unclear. Escitalopram belongs to the most commonly prescribe group of medications for depressive symptoms, the SSRIs, but nortriptyline (a “tricyclic”) has also been suggested to be effective and well tolerated. In addition, there is some preclinical evidence that nortriptyline changes some of the disease processes in Parkinson’s disease. The trial will examine how effective these treatments are for depressive symptoms in people with Parkinson’s, and also whether nortriptyline, is effective in delaying the slowing of movements associated with Parkinson’s.

The study involves assessments (face to face at study sites or remotely) before start of the trial medication, at 8 week, and then after 6 and 12 months. 

The study is being coordinated by the University College London and aims to recruit 408 patients in 20-30 sites across the UK.

Remote running of the trial through the Covid 19 pandemic

To ensure the trial is safe for patients with Parkinson’s in COVID19 times, the ADepT PD trial can now be run remotely from all sites, not requiring any hospital visits and reducing risk during the COVID19 pandemic.

Suitability Quiz
  • Have you been diagnosed with Parkinson’s disease?
  • Have you been having feelings of low mood or loss of enjoyment on most days?
  • Are you interested in helping to find out which antidepressant is best at treating your symptoms?
  • Are you interested in finding out whether one of them can change the progression of Parkinson’s?

Ask your clinician about the ADepT-PD trial, or contact one of the team at the sites below

Sites
Open sites:

Royal Free Hospital
Professor Anette Schrag:  0207 794 0500 Ext: 32964
Philip Poku: 0207 7940 500   Ext: 32964 
Laura Grover: 020 8016 8417
Email: philip.poku4@nhs.net or laura.grover.17@ucl.ac.uk 
General email: neuro.adept@ucl.ac.uk
Please contact Royal Free if there is no site close to you. The trial can be run remotely so you can be recruited from anywhere in the UK

John Radcliffe Hospital
Team contact: 01865 234614
Email: cristina.pelin@ouh.nhs.uk 

Luton and Dunstable University Hospital
Team contact: 01582 718300
Email: yvynne.croucher@ldh.nhs.uk 

North Tyneside General Hospital 
Dr James Fisher: 01670 529343
Steve Dodds: 0191 2934087
Email: steve.dodds@nhct.nhs.uk 

Lewisham and Greenwich University Hospital
Dr Flavia Niccolini: 0208 836 6936
Mrs Elena Walsh: 07880479977 or Mrs Lee Kieft 0208 836 6925
Email: elena.walsh3@nhs.net or lee.kieft@nhs.net 

St Peter's Hospital, Chertsey
Dr Jan Coebergh 01932 723534 (Research and Development Dept)
Email: gillian.carey2@nhs.net or louisa.aubry@nhs.net 

Charing Cross Hospital
Dr Sophie Molloy
Aaron Edwards: 0203-311-1234 ext 11714/11718
Email: aron.edwards2@nhs.net

Yeovil District Hospital
Dr Rani Sophia
Alison Lewis: 01935 606356,
Email: Clinical.Research@ydh.nhs.uk

National Hospital for Neurology and Neurosurgery (NHNN)
Dr Tabish Saifee
Emmima Angelina Manoharan: 020 3448 8608 
Email: a.manoharan@ucl.ac.uk / emmimaangelina.manoharan@nhs.net

Campus of Aging and Vitality
Dr Nicola Pavese: 0191 2081264
Kathryn Walker: 0191 208 1237/1250
Email: Kathryn.Walker@newcastle.ac.uk / Kathryn.Walker2@nhs.net

Royal Cornwall Hospital
Dr Oliver Leach
Suzy Dean: 01872 255177
Email: suzannedean@nhs.net

Cornwall Partnership NHS Foundation Trust
Dr Simon Vann Jones: 01209 204020
Charlotte Moorehouse: 01209 204020 / 07717 631919
Email: charlotte.moorehouse@nhs.net

Christchurch Hospital Research
Dr Khaled Amar
Rochelle Hernandez: 0300 019 5136
Email: rochelle.hernandez@rbch.nhs.uk

Addenbrooke’s Hospital
Dr Paul Worth
Robyn Weston/Lucy Chapman
01223 274564 / 01223 349286
Email: Lucy.chapman@addenbrookes.nhs.uk

Charing Cross Hospital
Dr Sophie Molloy
Idah Mojela 
020 3311 1718
Email: morongwa.mojela@nhs.net

Currently planned further sites:
Sheffield Institute for Translational Neuroscience
Lister Hospital

If there is no site near you please check again later as we aim to open sites all over the country

Personal views and experience

Personal views and experience on the difficulties patients may face in joining Adept -PD and why the project is so important

Before I knew that depression was a symptom of Parkinson’s, I didn’t realise that I had low mood – it was me and I lived with it.  “Pull yourself together,” often crossed my mind. After my Parkinson’s diagnosis, it still took me a long time to discuss the problem with my GP and consultant because I didn’t want to be labelled as what I saw as being ‘mentally ill’ or a ‘failure’. It wasn’t helped by the bad memories of my mother after many years on an outdated antidepressant. 
 But my fears were unfounded, I gained confidence in the professionals I saw, especially my Parkinson’s nurse and my GP. I became able to talk openly with them about dealing with my low mood and anxiety, and was helped immeasurably throughout from the wonderful support of my family. 
 I responded well to the initial tablets prescribed, and even changed my medication a couple of times to get the regime I felt worked best for me. But the fact remains that there is very little evidence out there to help professionals and PwP make informed decisions and choices in the medications to use. Finding the best anti-depressant for low mood in PwP would stop all the self-blame, and help people to regain their enjoyment in life. This is why this trial is so important - it could really make a difference. 

 Presentation and Q & A from Chief Investigator Anette Schrag and patient representative Chris Maycock 

YouTube Widget Placeholderhttps://youtu.be/JwsMesDe9UA
 
Meet the Team

Professor Anette Schrag

Professor Anette Schrag
ADepT PD Chief Investigator
Professor Anette Schrag is a Consultant Neurologist with an interest in Parkinson’s disease and Professor of Clinical Neurosciences at UCL Institute of Neurology, London. Her clinical research has concentrated on improvement of diagnosis and management of Parkinson’s disease, accurate assessment methods in clinical trials including the patients’ and carers’ points of view, the cognitive and neuropsychiatric aspects of Parkinson’s disease and the prodromal phase of the disease.
She has been involved in the creation of a number of recommendations on diagnosis, measurement and management of Parkinson’s disease, has acted as an advisor to several charities, has served on a number of committees of the International Parkinson’s Disease and Movement Disorders Society, and leads several research studies in Parkinson’s disease and other disorders

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Felicia Ikeji
ADepT Clinical Project Manager
Felicia joined UCL CCTU in 2015 and oversees all aspects of the ADEPT-PD trial in her role as Clinical Project Manager
Blair McLennan

Blair McLennan

ADepT PD Trial Manager
Blair graduated from the University of Sydney with a degree in Health Information Management. He then worked as a Clinical Trial Coordinator in both Sydney and then London. He moved to a role as a Clinical Trial Manager in 2013 and has since managed trials in various research areas including Mental Health, Oncology and Intensive Care. Blair joined the UCL CCTU in 2019.


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Zainab Mohamed

ADepT PD Data Manager
Zainab holds a Master in Science (MSci) degree in Pharmacology from King’s College London. In 2019, she went on to work at Guy’s and St Thomas’ NHS Foundation Trust, as a Clinical Trials Associate on a range of research studies relating to urological and renal conditions. Zainab is now working at the Comprehensive Clinical Trials Unit at UCL as a data manager.


Laura Grover

Laura Grover

ADepT PD Research Assistant
Laura graduated from the University of Exeter with a BSc in Psychology in 2017. This led to completion of an MSc in Clinical Mental Health Sciences at UCL, where she graduated with a distinction. Following this, Laura went on to work as a Clinical Research Assistant at University Hospitals of Leicester NHS Trust, on a range of covid-19 research studies. She then returned to UCL in October 2020 where she is currently working as a Research Assistant at the Institute of Neurology.

Information for Clinicians

Summary of key inclusion and exclusion criteria
Inclusion:

  1. Diagnosis of Parkinson’s disease
  2. Aged 18 to 85 years.
  3. Either:
    - Operationally defined subsyndromal depression (presence of two or more depressive symptoms, at least one of which has to include depressed mood or anhedonia) OR
    - Fulfilling diagnostic (DSM-V) criteria for a depressive disorder (i.e., major depressive disorder or persistent depressive disorder) 
  4. Beck Depression Inventory-II (BDI-II) score ≥14.
  5. Treatment with antiparkinsonisan medication is optimised or stable for at least 4 weeks and no plans to change up to primary endpoint (8 weeks)

Exclusion:

  1. Women who are pregnant, breastfeeding or of childbearing potential without effective contraception 
  2. Not able to understand the Patient Information Sheet or the self-completed questionnaires or unable to communicate answers to the self-rating questionnaires.
  3. Montreal Cognitive Assessment (MoCA) score <16 or without capacity to consent.
  4. Treatment with an antidepressant within 4 weeks of enrolment (except for a small dose of amitriptyline up to 30 mg for indications other than depression).
  5. Known severe liver failure.
  6. Absolute contraindications to escitalopram or nortriptyline. These include:
    a. Patients with known QT-interval prolongation (defined here as >420ms) or congenital long QT syndrome.
    b. Recent myocardial infarction (<3 months), any degree of heart block or other cardiac arrhythmias.
  7. Medications contraindicated on nortriptyline or escitalopram. These include:
    a. Non-selective and selective irreversible monoamine oxidase inhibitors (MAOIs) within 14 days. However, the antiparkinsonian selective reversible MAO-B inhibitors rasagiline, selegiline and safinamide are not contraindicated.
    b. Concomitant QT prolonging drugs, including domperidone, apomorphine at high doses (single dose or hourly rate of >6mg), certain neuroleptics (not quetiapine or clozapine), quinine, class IA and III antiarrhythmics (amiodarone, dronedarone and disopryamide), the antihistamines (astemizole, mizolastine), the antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malarian treatment, and some antiretrovirals.
  8. Active suicidal ideation or intent
  9. Participation in another clinical trial of an investigational medicinal product or device
Funder
CCTU

The Comprehensive Clinical Trials Unit (CCTU) at UCL will design, conduct, analyse and report high quality clinical trials and other well designed studies that fit with the research strategies of UCL and UCL Partners.
In pursuit of this Mission, the UCL Comprehensive Clinical Trials Unit will:

Develop partnerships with clinical investigators at all relevant institutions Promote a trial governance structure that supports a compliant, risk-based, proportional approach to the application of regulations

 

The UCL CCTU will accomplish its mission through CCTU staff and collaborators supporting adoption of its policies and procedures

  • Provide clinical trials leadership and expertise across the whole range of activities required to deliver trials from concept to dissemination and implementation of research findings
  • Employ highly experienced staff with diverse research interests and expertise in clinical trial methodology to enhance the effectiveness of the research pathway