RecruitingPHASE4INTERVENTIONAL

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)

The OPTIMUM-D study aims to find a better way to predict which treatment will help people with depression. Currently, finding the right medication can involve a lot of trial and error. This study is testing a special computer program, or 'algorithm,' that uses information from brain scans, electrical brain activity (EEG), and other body measurements to try and match people with the most suitable treatment. Participants will receive escitalopram, a common antidepressant, sometimes with brexpiprazole. The main goal isn't to test if these medicines work, as they are already approved, but rather to see if the predictive tool can help choose the right one for you. This might lead to more personalised and effective depression care in the future.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Nova Scotia Health Authority

Enrolment target

400

Start

20 Jan 2023

Estimated completion

30 Apr 2029

Major Depressive Disorder

What is this study about?

Imagine you're trying to find the best way to treat your depression, but it feels like guessing which medicine will work. The OPTIMUM-D study is trying to make this process much smarter. Researchers are testing a special tool, a bit like a highly advanced computer program, that could help doctors pick the right treatment for you from the start, rather than through trial and error.

The study focuses on people experiencing a major depressive episode. They want to see if this special tool, which uses various bits of information like brain scans and other body markers, can accurately predict whether adding a second medication, called brexpiprazole, to a common antidepressant, escitalopram, will be helpful. Both escitalopram and brexpiprazole are approved medications for depression that doctors in the UK already prescribe.

This isn't a study to prove if these medicines work – we already know they do for many people. Instead, it's about making treatment more personal. If this tool is successful, it could mean that in the future, people with depression could get the most effective treatment for them much faster, helping them feel better sooner.

Key takeaways

Aims to find a smarter, more personal way to treat depression.
Tests a computer tool to predict which medication works best for you.
Uses approved depression medications: escitalopram and brexpiprazole.
Participation involves about 12 weeks, with regular check-ups.
You might not know which specific medication you're taking for part of the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and be experiencing a major depressive episode. You can't have recently started other mental health treatments or be taking certain medications for depression. Also, you must be able to understand and complete forms in English.

There are several reasons why you might not be able to join. For example, if you have certain other mental health conditions like bipolar disorder, or if you've had issues with drug or alcohol misuse recently. If you're pregnant or breastfeeding, or if your doctor thinks you're at high risk of harming yourself, you won't be able to take part. Also, if a particular medication has already not worked for you several times in the past, or if escitalopram has caused problems before, you probably won't be eligible.

The study also includes healthy volunteers, aged 18 to 65, who have no history of mental health conditions or serious physical illnesses, and can complete forms in English. These volunteers help the researchers understand how different measurements look in people without depression.

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 between 18 and 65 years old?
Do you currently have symptoms of major depression?
Have you been off most depression medications for at least a week?
Are you fluent in English?
Are you not pregnant or breastfeeding?
Do you have a history of serious mental health conditions other than depression (like bipolar disorder)? (If yes, you may not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 12 weeks in total. For the first 8 weeks, you'll be randomly assigned to one of two groups. In one group, the doctors will use the special prediction tool to decide if you receive escitalopram with a second medication (brexpiprazole) or a dummy pill (placebo). In the other group, it will be a random choice, like flipping a coin, whether you get brexpiprazole or a dummy pill alongside escitalopram.

During these 8 weeks, you and the study staff won't know if you're receiving brexpiprazole or the dummy pill alongside your escitalopram. After 8 weeks, if you're feeling much better, you'll continue with escitalopram. If not, or if you were already on escitalopram and brexpiprazole, you'll continue with escitalopram and brexpiprazole (and everyone will know what medications they are taking) for another 4 weeks. Throughout the study, you'll have regular visits for assessments, which will include talking to doctors, filling out questionnaires, and potentially having brain scans and other tests.

Potential risks and benefits

Participating in this study might offer you the potential benefit of finding a more suitable treatment for your depression sooner than you might otherwise. However, there are also potential risks, such as experiencing side effects from the medications, escitalopram and brexpiprazole, which are well-known and will be discussed with you. You'll also need to commit time for appointments and assessments. It's very important to remember that joining a study is always your choice, and you can withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (7)

University of Calgary
Verified postcode
Calgary, Canada· Not yet recruiting
University of British Columbia
Verified postcode
Vancouver, Canada· Not yet recruiting
Nova Scotia Health Authority
Verified postcode
Halifax, Canada· Recruiting
McMaster University
Verified postcode
Hamilton, Canada· Not yet recruiting
Queen's University
Verified postcode
Kingston, Canada· Not yet recruiting
University Health Network
Verified postcode
Toronto, Canada· Not yet recruiting
Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada· Not yet recruiting

Common questions

What is a 'biomarker algorithm'?

It's like a smart computer program that uses information from scans, brain activity, and other body tests. It tries to predict which medicine might work best for you.

Are the medications safe?

Yes, both escitalopram and brexpiprazole are approved medications for depression, commonly used by doctors, and Health Canada has approved them for this study.

Will I know which treatment I'm getting?

For the first 8 weeks, you won't know if you're getting brexpiprazole or a dummy pill alongside escitalopram. This is to make sure the results are fair.

What if the treatment isn't working for me?

You will be monitored closely. If your treatment isn't helping after 8 weeks, adjustments will be made, and your doctors will discuss the best next steps with you.

How long will I be in the study?

The study lasts about 12 weeks in total, with more intensive assessments in the first 8 weeks.

How to find out more

Nicole Stinson, BSc

nicole.stinson@nshealth.ca 9024735313 Official trial record

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