RecruitingPHASE2INTERVENTIONAL

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

This study is for people aged 60 and over who have moderate to severe depression, sometimes called ‘late-life depression’. This condition can make thinking and moving slower. Researchers are testing if a drug called L-DOPA, which helps with a brain chemical called dopamine, can improve these symptoms. Participants will take L-DOPA for two weeks, and their mood, thinking, and movement will be checked before and after. The main goal is to see if taking L-DOPA is practical for people and if it helps with slowed thinking and memory issues. If depression remains severe after L-DOPA, participants will receive standard antidepressant treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of British Columbia

Enrolment target

Start

15 Aug 2024

Estimated completion

30 May 2026

Major Depressive Disorder

What is this study about?

If you're over 60 and experiencing symptoms of major depression, you might hear it called 'late-life depression'. This type of depression can often make daily life harder and is linked to problems like feeling physically weaker or even memory issues. A common sign of more severe late-life depression is 'psychomotor slowing', which means your ability to think and move can become sluggish. For example, you might find yourself walking or processing information more slowly, and your working memory—the ability to hold and use information in your mind—might not be as sharp.

Scientists believe that this psychomotor slowing could be connected to a problem with how your brain produces or uses an important chemical messenger called dopamine. You might have heard of L-DOPA (Levodopa); it's a medicine that can help replace missing dopamine in the brain and has been used for many years to treat Parkinson's disease. Researchers are now exploring whether L-DOPA could also be helpful in improving the psychomotor slowing seen in late-life depression.

This study aims to find out two main things. First, how practical and comfortable it is for people to take L-DOPA as part of a short-term 'challenge'. This means seeing if participants can complete the treatment without too much difficulty, for example, if they can manage any side effects or attend the necessary appointments. Secondly, the study will investigate if L-DOPA helps to improve symptoms of depression, speed up thinking, and boost working memory. The researchers will be looking to see if improvements in walking speed after taking L-DOPA are linked to better mood, faster thinking, and sharper memory.

Key takeaways

The study focuses on depression in people over 60.
It tests L-DOPA as a potential treatment for slow thinking and movement.
Participants will take L-DOPA for two weeks under medical supervision.
Mood, thinking speed, and memory will be assessed.
If needed, standard antidepressant treatment will follow for 12 weeks.
Your health and safety will be monitored throughout the study.

Who may be eligible?

This study is looking for volunteers who are 60 years old or older and have moderate to severe depression. You should be able to attend appointments as needed and consent to take part yourself. If you are already taking medication for your mood, you need to have been on a steady dose for at least four weeks.

However, there are reasons why you might not be able to join. For example, if you have a current diagnosis of severe dementia or other major memory problems, or if you are currently experiencing symptoms like hallucinations or delusions. Also, if you have certain serious or unstable health conditions, such as severe heart, liver, or kidney disease, or if you have a history of melanoma (a type of skin cancer) or specific heart rhythm problems, you might not be suitable.

Other reasons for not being able to take part include if you have a history of frequent falls (more than one fall per week recently), severe glaucoma, certain stomach ulcers, or if you are taking specific medications that could interfere with the study drug. You also need to be able to hear and see well enough to complete thinking and memory tests, and understand English for these tests.

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.

Are you 60 years old or older?
Do you have moderate to severe depression?
Have you been on a stable dose of any mood medication for at least 4 weeks?
Are you generally in good health and able to attend regular appointments?
Do you not have major memory problems or severe heart/kidney/liver disease?
Do you understand English well enough for tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves a 'L-DOPA challenge' for two weeks. For the first week, you will take L-DOPA once a day, and for the second week, you will take it twice a day. You will need to visit the research site regularly to get your medication. Before and after this two-week period, the study team will carry out assessments to check your mood, your thinking speed, and your memory. This is to see if the L-DOPA has had any effect.

If, after the two weeks of L-DOPA, you are still experiencing moderate or severe depression, you will then be offered a standard antidepressant medication. This antidepressant treatment will last for 12 weeks. The total duration of your participation, including the L-DOPA challenge and potential antidepressant treatment, would be around 14 weeks.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a close watch on your depression symptoms and access to medication that might improve your mood, thinking, and movement. However, like all medications, L-DOPA can have side effects, and your doctor or the study team will discuss these with you. Some people might find the regular visits for medication or assessments demanding. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'late-life depression'?

It's when people aged 60 or older experience symptoms of major depression, which can include slower thinking and movement.

What is L-DOPA?

L-DOPA is a medication that helps the brain produce more dopamine, a natural chemical messenger. It's often used for Parkinson's disease.

Will I have to pay for any of the medication?

No, all study medications and assessments will be provided at no cost to you.

What if L-DOPA doesn't help my depression?

If your depression is still moderate or severe after the L-DOPA challenge, you will then receive a standard antidepressant for 12 weeks as part of the study.

How long will I be involved in the study?

You will be involved for about 14 weeks in total, including the two-week L-DOPA challenge and a potential 12-week antidepressant treatment.

How to find out more

Nicholas J Ainsworth, MD

nainsworth@providencehealth.bc.ca 6048069090 Official trial record

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