AuthorisedTherapeutic use (Phase IV)Interventional

A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

This study, called PREDICT, aims to find out if using a special gene test can help doctors pick the most effective antidepressant medication for people who are struggling with depression, particularly if previous treatments haven't worked as expected. Participants will be randomly assigned to either have this genetic information guide their treatment or receive standard care. Researchers will carefully track how well symptoms improve, how many times medication adjustments are needed, and if this new approach is a good value for money. The goal is to see if tailoring antidepressant choice based on a person's genes can lead to better outcomes and fewer changes in medication.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Enrolment target

240

Start

11 Jan 2026

Depressive disorder

What is this study about?

Imagine you're trying to find the best medicine for your depression, but it feels like a bit of guesswork. This study, called PREDICT, is looking into a new way to help doctors choose the right antidepressant for you more quickly and effectively. It's for people who have depression and whose current treatment isn't working as well as hoped.

The main idea is to see if looking at your genes can give your doctor clues about which antidepressant might work best for you. Our bodies are all a little different, and these differences, including our genes, can affect how we react to medicines. So, this study wants to compare two approaches: one where doctors use information from a gene test to help decide which antidepressant to prescribe, and another where they follow the usual methods for choosing medication.

By comparing these two groups, the researchers want to understand if using genetic information can lead to people feeling better sooner, needing fewer changes to their medication, and ultimately, whether it's a more efficient way to treat depression. They will also be looking at whether this approach makes economic sense within the healthcare system.

Key takeaways

This study explores using gene tests to help select antidepressants.
It's for adults with depression who haven't fully responded to previous treatment.
Participants will receive standard antidepressants, with or without genetic guidance.
The study lasts 16 weeks with regular check-ups.
Aims to see if genetic guidance leads to better and faster symptom improvement.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would be suitable if you have been diagnosed with depression and have tried an antidepressant before, but it hasn't fully helped your symptoms. The study is specifically for people whose current depression treatment isn't working as well as it could.

The research team will carry out some checks to make sure the study is a safe and appropriate option for you. They will explain everything clearly, and you'll have the chance to ask any questions you have.

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 18 years old or older?
Do you have a diagnosis of depression?
Have you tried an antidepressant before that didn't fully help?
Are you willing to potentially have your treatment guided by a genetic test?
Are you able to attend regular appointments for 16 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will have their antidepressant choice guided by a genetic test, and the other will receive standard care. You won't know which group you're in, and your doctor won't either, until your treatment choice is made. You'll receive one of several common antidepressant medications, based on your group assignment and your doctor's choice.

Over a period of 16 weeks, you'll have regular check-ups with the study team. These visits will involve answering questions about how you're feeling and how well your medication is working. These questions will help measure your depression symptoms. The team will also keep track of any other treatments you might need, like talking therapies, and any side effects you experience. Your doctor might adjust your medication dose or switch to a different one if needed, as part of your ongoing care. The total duration of active participation and follow-up will be 16 weeks.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of finding an antidepressant that works better for you more quickly. However, like all medications, the antidepressants used in this study can have side effects, and some may be serious. The study team will carefully monitor you for any side effects and provide support. There's also a possibility that the new treatment might not work for you, or that you might not experience any direct benefit from participating. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'gene test' in this study?

It's a test that looks at specific parts of your DNA to give doctors extra information about how your body might react to certain antidepressants, helping them make a more informed choice.

Will I definitely get a genetic test if I join?

You might. The study has two groups, and only one group will have their treatment guided by genetic test results. You'll be randomly assigned to one of these groups.

What kind of medications are being studied?

The study uses a range of well-known antidepressant medications that are commonly prescribed for depression.

How long will I be in the study?

Your active involvement and monitoring will last for 16 weeks after you start your new antidepressant treatment.

What if the new medication doesn't work for me?

The study team and your doctor will be closely monitoring your progress and can make adjustments to your treatment, including changing your medication or dose, if needed.