ADepT-PD
Research type
Research Study
Full title
A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline with Standard Psychological Care for Depression in Parkinson’s Disease
IRAS ID
235544
Contact name
Gemma Jones
Contact email
Sponsor organisation
University College London Comprehensive Clinical Trials Unit
Eudract number
2018-002942-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, days
Research summary
Parkinson’s disease (PD) is a progressive neurological disorder that leads to increasing disability and functional decline. Currently, no medications have been shown to halt or delay disease progression. One of the most common complications in patients with this diagnosis is depression, which affects approximately 40% of patients with PD. It is linked to functional impairment, cognitive decline and faster disease progression and is the main determinant of poor quality of life in PD. Psychological therapies are used to treat depressive symptoms (via standard access to appropriate psychological services in the NHS), but often antidepressant medications are required. Despite the high incidence of depression in this population, no conclusive evidence on appropriate choice of antidepressants in PD exists in the NHS; the risk of worsening of parkinsonism and aggravation of non-motor features of PD by antidepressants pose particular challenges in this population.
The aim of the trial is to test the clinical effectiveness and cost-effectiveness of two different types of antidepressants: escitalopram ( a and nortriptyline treatment for depression in PD in addition to standard psychological care. Patients will be randomly assigned to one of the two drugs or a placebo and followed up for one year.
Lay summary of study results: Plain Language Summary What was the question?
The “Antidepressants for depression in people with Parkinson’s Disease” (AdepT-PD) trial was designed to assess the effects of two different types of antidepressants for depressive symptoms in Parkinson’s. They are commonly used in the NHS but it is unclear how effective they are in people with Parkinson’s.What did we do?
This trial attempted to compare nortriptyline, a drug from the class of tricyclics, and escitalopram, a drug from the class of antidepressants known as Selective serotonin reuptake inhibitors (SSRIs) with identical-looking tablets that did not contain any of the drug (a placebo) to find out if they reduce these symptoms more than placebo and to compare their effects.What did we find?
We were able to recruit only a small number of patients with depression in Parkinson’s willing and able to participate in a randomised placebo-controlled trial with antidepressants. The main reason was that most people who have these symptoms are now already offered antidepressants already available in the NHS. This made it difficult to recruit to a trial with these medications despite several strategies including completely remote delivery.What does this mean?
Depression is a common feature of Parkinson’s and once recognised it is now frequently recognised and commonly treated with antidepressants. Trials evaluating response to antidepressants for depression in Parkinson’s compared to placebo and between different available antidepressants are therefore challenging. The information gathered on challenges in conducting large trials in Parkinson’s in the UK, including remote delivery, is already helping design of other UK-wide trials in Parkinson’s.REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0288
Date of REC Opinion
15 Mar 2019
REC opinion
Favourable Opinion