RecruitingNAINTERVENTIONAL

Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression

This study aims to find the best way to prescribe antidepressant medication for young people aged 12-17 who are starting or changing treatment for anxiety or depression. Researchers will compare two approaches: one where a special gene test helps doctors choose the right medication, and another where doctors follow current standard guidelines. The gene test looks at how a person's body processes medicines, which might affect how well an antidepressant works or if it causes side effects. Over 12 weeks, the study will track how young people feel and whether the new gene-guided approach leads to better outcomes than the usual method. This research is important because it could help doctors make more informed decisions when prescribing these medications, potentially improving care for young people.

At a glance

Status

Recruiting

Phase

Sponsor

University of Calgary

Enrolment target

452

Start

11 Feb 2025

Estimated completion

01 Dec 2027

Anxiety and Depression

What is this study about?

When young people, especially teenagers aged 12 to 17, experience anxiety or depression, doctors often prescribe a type of antidepressant medication called an SSRI. Common examples include fluoxetine (which is often the first choice) and others like sertraline or citalopram. While these medications can be very helpful, sometimes it can take a bit of trial and error to find the one that works best for each individual without causing too many side effects.

Currently, doctors mainly follow general guidelines when prescribing these medications. However, people's bodies process medicines differently based on their genes – think of it like how some people can drink coffee late at night and others can't. These genes can affect how quickly a drug is broken down, which can influence how effective it is or if side effects occur. Current guidelines don't usually take these genetic differences into account.

This study is testing a new approach called 'pharmacogenetic-guided prescribing'. This involves using a simple gene test to understand how a young person's body handles certain medications. The researchers want to see if using this information to help choose the antidepressant leads to better results for young people with anxiety or depression after 12 weeks, compared to just following the standard prescribing guidelines.

Key takeaways

The study tests if gene-guided medicine choice helps young people with anxiety/depression.
It compares a gene test approach with standard antidepressant prescribing.
Participants are 12-17 years old, starting or changing an antidepressant.
The study lasts 12 weeks, tracking how young people feel.
Neither patients nor doctors will know which treatment group they are in.

Who may be eligible?

This study is looking for young people aged between 12 and 17 years old who have anxiety and/or depression. You would be considered for the study if your doctor has decided that you need to start a new SSRI antidepressant medication or switch to a different one. You would also need to be able to understand and speak English.

However, there are some reasons why you might not be able to join. For example, if you have certain other conditions like obsessive-compulsive disorder (OCD), bipolar disorder, or a history of psychosis. Also, if you've already tried three or more SSRI medications without success, or if you've recently had certain brain stimulation treatments, or have plans to start them soon, you wouldn't be eligible.

Finally, if you've had a liver or blood cell transplant, or if you've already had genetic tests done that look at how your body processes medicines (specifically CYP2B6, CYP2C19, or CYP2D6 genes), you would not be able to take part in this research.

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 12 and 17 years old?
Do you have anxiety or depression diagnosed by a doctor?
Is your doctor planning for you to start or change an SSRI antidepressant?
Can you understand and speak English?
Do you have certain other conditions such as OCD, bipolar disorder, or a history of psychosis that might exclude you from the study? (You might need to discuss this with your doctor.)
Have you had liver or blood cell transplants, or specific genetic tests related to how you process medicines (CYP2B6, CYP2C19, or CYP2D6)? (These would mean you couldn't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: one where a gene test helps guide your antidepressant choice, or one where your doctor follows standard prescribing advice. Neither you nor your doctor would know which group you are in. The study involves taking an SSRI antidepressant for 12 weeks. During this time, your progress and how you are feeling would be monitored. The study will last for 12 weeks, during which you would have regular check-ups with your doctor.

Potential risks and benefits

Taking part in this study could offer the potential benefit of finding an antidepressant medication that is better suited to you, possibly leading to fewer side effects or more effective treatment, guided by your genetic profile. However, there are no guarantees that this new approach will work better for everyone. All medications carry potential risks and side effects, and these will be carefully monitored by your doctor. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is an SSRI?

SSRIs are a common type of antidepressant medication used to treat depression and anxiety by affecting a chemical in your brain called serotonin.

What is a 'gene test' in this study?

A 'gene test' in this study is a way of looking at your genes to understand how your body handles certain medicines, which might help doctors choose the best antidepressant for you.

Will I know if I'm in the gene-guided group?

No, neither you nor your doctor will know whether your treatment is being guided by the gene test results or by standard guidelines. This is done to make the study fair.

How long will I be in the study?

You'll be taking part in the study and receiving your antidepressant treatment for 12 weeks, with regular check-ups.

What if the medication doesn't work for me?

Your doctor will monitor your progress closely throughout the 12 weeks and adjust your treatment as needed, just like with standard care.

How to find out more

Meagan Shields, BSc., MSc.

gap@ucalgary.ca 403-210-6353 Official trial record

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