CompletedPhase IIInterventional

Noradrenaline treatment of apathy and impulsivity in participants with Progressive Supranuclear Palsy syndromes

Progressive Supranuclear Palsy (PSP) is a condition that affects balance and movement, but it can also cause changes in behaviour. Many people experience a loss of motivation (apathy) or act without thinking (impulsivity). These changes can be difficult for both patients and their families, and they may be linked to low levels of a brain chemical called noradrenaline. This study tests whether a medicine called atomoxetine can safely restore these chemical levels and help with behavioural symptoms. Atomoxetine is already used for other medical conditions. During the study, everyone will try the real medicine for eight weeks and a dummy pill (placebo) for eight weeks, separated by a short break. You and a family member or carer will attend hospital visits to complete simple memory tests and questionnaires, helping researchers learn if atomoxetine could be a helpful treatment.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

16 Apr 2021

Estimated completion

31 May 2025

Progressive supranuclear palsy

What is this study about?

Progressive Supranuclear Palsy (PSP) is an uncommon brain condition. While it is best known for causing problems with walking, balance, and eye movements, it also affects how people feel and act. Many people with PSP experience severe apathy, which means losing motivation or interest in activities they once enjoyed. Others may show impulsivity, meaning they act quickly on impulse without considering risks. These changes happen because of changes in the brain, but they can be very stressful for individuals and their carers.

Scientists believe these behavioural symptoms occur partly because the brain loses a natural chemical called noradrenaline. Noradrenaline helps control attention, motivation, and decision-making. This clinical trial is testing whether a drug called atomoxetine can boost noradrenaline levels in people with PSP. Atomoxetine is already widely used for other conditions, but doctors need to find out if it is safe, well-tolerated, and helpful for people living with PSP.

Because this is a 'crossover' study, every participant will have a turn taking atomoxetine and a turn taking a harmless dummy pill (placebo). Neither you nor your research doctor will know which pill you are taking first. This setup allows researchers to compare the effects fairly and ensures nobody misses out on trying the actual medication.

Key takeaways

The study tests whether atomoxetine can help with apathy and impulsivity in PSP.
Every participant gets to try both the real medicine and a dummy pill for eight weeks each.
You need a carer or family member to join as your research partner.
The trial takes about 22 weeks and involves six visits to the study hospital.
Taking part is completely voluntary and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged between 50 and 85 who have been diagnosed with Progressive Supranuclear Palsy (PSP). To take part, you must have the mental capacity to understand the study and agree to join. You will also need a 'research partner'—such as a relative, close friend, or carer—who sees or speaks to you regularly and is willing to answer questions about your daily life and wellbeing.

To ensure your safety, your regular medications must be stable for at least four weeks before joining the study, with no planned changes to any brain-related medicines. You should also be generally well enough to attend hospital appointments.

You cannot take part if you are pregnant or breastfeeding. Women who could become pregnant will need to take routine pregnancy tests during the study. If you have other severe medical conditions that make taking part unsafe, the study doctors will discuss this with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with Progressive Supranuclear Palsy (PSP).
I am aged between 50 and 85 years old.
I have a family member, friend, or carer who can attend study visits with me.
My current medications have been stable for at least 28 days.
I am able to give informed consent and attend hospital appointments in the UK.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for around 22 weeks and involves six visits to a study hospital. At your first visit, the team will explain the study in detail, check your health, and ask you and your research partner to sign consent forms. You may also choose to have an optional brain scan (MRI) or blood tests.

Next, you will be given your first set of pills to take at home for eight weeks. By chance, like tossing a coin, you will receive either atomoxetine or a dummy pill. You will visit the hospital at the start and end of this period for simple questionnaires, health checks, and thinking tasks. You will then have a two-week break where you stop study pills and only take your usual medicines. After this break, you switch over: if you had the dummy pill first, you will now take atomoxetine, and vice versa, for another eight weeks. Finally, four weeks after finishing your second course of pills, you will have one last hospital visit for closing health checks.

Potential risks and benefits

There is no guarantee that taking atomoxetine will improve your symptoms. However, taking part will provide valuable insights into PSP and may help doctors develop better treatments for people with this condition in the future. Atomoxetine is given at standard clinical doses and is generally well tolerated, but like any medicine, it can cause side effects such as nausea, sleep changes, dry mouth, or changes in blood pressure. The study team will monitor you closely at every step. Joining this trial is entirely your choice, and you can change your mind and leave the study at any time without giving a reason and without affecting your normal NHS care.

Locations (7)

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle-upon Tyne, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Salford Royal Hospital
Approximate
Salford, England
John Radcliffe Hospital
Approximate
Oxford, England
Royal Gwent Hospital
Unverified
Newport, Wales
Queen Elizabeth University Hospital
Unverified
Glasgow, Scotland

Common questions

Will I definitely receive the study medication?

Yes. This is a crossover study, which means every person who completes the trial will take the real medicine (atomoxetine) for eight weeks and the dummy pill for eight weeks at different times.

What is a research partner and why do I need one?

A research partner is a relative, friend, or carer who knows you well and is in regular contact. They help by attending visits, supporting you, and answering simple questionnaires about any changes in your behaviour or daily life.

Do I have to stop taking my regular medicines?

In most cases, no. You can usually carry on with your usual medications, but they must have been at a steady dose for at least four weeks before you begin the trial.

Are the hospital visits painful or difficult?

Most visits involve simple health checks, blood pressure measurements, and completing puzzles or questionnaires. Optional parts, like an MRI scan or giving a blood sample, are not mandatory to take part.

Can I leave the study early if I want to?

Yes. You can leave the study at any time, for any reason. Your decision will never affect the standard medical care you receive from the NHS.

How to find out more

James Rowe

james.rowe@mrc-cbu.cam.ac.uk +44 (0) 1223 273 630 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.