RecruitingNAINTERVENTIONAL

Effects of NAC on Symptoms of CHR Patients

This research is looking for new and gentler ways to help young people who show early signs that they might be at high risk of developing psychosis. Psychosis is a serious mental health condition. Current treatments for these early signs often have unpleasant side effects, so doctors don't usually recommend them. This study investigates a supplement called N-acetylcysteine, or NAC for short. NAC is thought to help protect brain cells from damage. Researchers want to find out if NAC can reduce psychosis-like symptoms and improve the way the brain works in people at high risk. The goal is to see if NAC could be a safe and effective way to help prevent the development of psychosis.

At a glance

Status

Recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

Start

13 Jan 2023

Estimated completion

31 Dec 2026

Prodromal Schizophrenia

What is this study about?

This study is about finding new ways to help young people who are showing early signs that they might be at high risk of developing psychosis. Psychosis is a serious mental health condition that can make it hard to tell what's real and what's not. These early signs are often milder versions of what someone with psychosis might experience, and doctors call this a "clinical high-risk" (CHR) state. Helping people at this stage can sometimes stop psychosis from fully developing.

The challenge with current treatments for these early signs is that they often come with unwanted side effects. Because of this, medical guidelines don't usually suggest using these medications routinely. So, there's a real need to find new treatments that are safer and easier to tolerate. This study is exploring if a natural supplement called N-acetylcysteine, or NAC, could be one of these new treatments.

Scientists believe that something called "oxidative stress" in the brain might play a role in psychosis. Oxidative stress happens when there are too many harmful molecules, called free radicals, and not enough protective molecules, called antioxidants, to balance them out. NAC is a building block for glutathione, which is a very important antioxidant in the brain. Previous research suggests that NAC might be safe and well-tolerated, and could help reduce symptoms and improve how the brain works in people at high risk of psychosis.

Key takeaways

The study is looking for gentler treatments for early signs of psychosis risk.
It tests a supplement called NAC, which might protect brain cells.
Participants take either NAC or a dummy pill for 8 weeks.
Regular check-ups and brain activity tests are part of the study.
The goal is to see if NAC can reduce symptoms and improve brain function.
Your medical care won't be affected if you choose not to join or leave the study.

Who may be eligible?

To join this study, people must be between 16 and 35 years old. They need to be showing specific early signs of being at high risk for psychosis, as identified by a special interview. If you're able to understand and agree to take part, that's also important.

There are also some reasons why someone couldn't join. For example, if you have other serious mental health conditions (though some, like nicotine use or past drug use that has stopped, might be okay), or if you have certain brain conditions or vision problems that glasses don't fix. You also can't have been treated with certain strong anti-psychotic medicines in the past, or be currently taking most other mental health medications, unless it's an antidepressant you've been on for a stable amount of time.

For women, you can't be pregnant, planning to become pregnant, or breastfeeding. Also, if you have a history of kidney stones, are currently taking certain antibiotics or a heart medication called nitroglycerin, or have an allergy to any part of the study drug or placebo, you wouldn't be able to participate.

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.

Am I between 16 and 35 years old?
Have doctors said I show early signs of being at high risk for psychosis?
Do I have any serious brain conditions or uncorrected vision problems?
Am I pregnant, breastfeeding, or planning to become pregnant?
Do I have a history of kidney stones or certain allergies?
Am I taking certain medications like specific antibiotics or nitroglycerin, or have I had strong anti-psychotic treatment in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to either take the NAC supplement or a dummy pill (placebo) every day for 8 weeks. This is a "double-blind" study, meaning neither you nor the study doctors will know whether you're taking NAC or the placebo. You'll have visits at the start of the study, at week 4, and at week 8 to check your symptoms and how you're feeling. At the start and at week 8, you'll also have brain tests that involve listening to sounds and looking at words or pictures to see how your brain responds. The total duration of active participation in the study will be 8 weeks.

Potential risks and benefits

While we hope NAC might help reduce the risk of psychosis or lessen symptoms, there's no guarantee it will work for everyone, as this is still a research study. Potential benefits include close monitoring by medical professionals. Risks are generally expected to be low, as NAC is usually well-tolerated, but like any treatment, there's a small chance of side effects. You might also experience minor discomfort from the brain tests. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is psychosis?

Psychosis is a serious mental health condition where a person might have trouble knowing what's real. They might see or hear things that aren't there, or have strong beliefs that aren't based in reality.

What does 'clinical high-risk' mean?

It means someone is showing some early, milder symptoms that suggest they might be more likely to develop psychosis in the future, but they don't have full-blown psychosis yet.

What is N-acetylcysteine (NAC)?

NAC is a supplement that helps your body make a natural antioxidant called glutathione, which protects brain cells from damage. It's often used for other medical conditions.

Will I know if I'm taking the real drug or the dummy pill?

No, neither you nor the doctors will know. This is called 'double-blind' and helps make sure the study results are fair and accurate.

What are 'brain tests' like?

These tests are non-invasive and involve placing sensors on your scalp to measure brain activity while you listen to sounds or look at words/pictures. They don't involve needles or discomfort.

How to find out more

Michael Kiang, MD, PhD

michael.kiang@camh.ca 416-535-8501 Official trial record

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