Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

AMEND - Add-on MEmaNtine to Dopamine modulation to improve negative symptoms at first psychosis

This important research, called AMEND, is investigating new ways to help young people who are experiencing their first episode of psychosis. The study aims to find out if adding a medication called memantine to their standard treatment (which often includes medicines like aripiprazole) can reduce difficult 'negative symptoms'. These symptoms can include feeling low in energy, having less interest in activities, or withdrawing from social situations. Doctors will be carefully monitoring participants over 12 weeks to see if memantine helps improve these symptoms, and also looking at other things like memory, daily functioning, and any side effects. The goal is to find better ways to support recovery for people dealing with psychosis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Region Hovedstadens Psykiatriske

Enrolment target

Start

11 Nov 2024

First episode psychosis ICD-10: F20.x

What is this study about?

The AMEND study is looking into new ways to help people aged 18 and over who are going through their very first episode of psychosis. Psychosis is a serious mental health condition where a person might experience altered thoughts, feelings, perceptions, and behaviours. Current treatments often involve medicines that help manage some of these symptoms, but there are still areas where we can improve care.

This study specifically focuses on what doctors call 'negative symptoms'. These aren't about being negative in a grumpy way, but rather a reduction or absence of typical behaviours and feelings. For example, someone might lack motivation, struggle to feel joy, or find it hard to socialise. These symptoms can be very challenging and make it difficult to get back to daily life. The AMEND study is testing if adding a medicine called memantine to a person's current treatment can help lessen these specific symptoms.

Memantine is a medicine that works on brain chemicals in a different way to usual psychosis medications. Researchers want to see if this different approach, when used alongside existing treatments, can offer better support for recovery. The study will carefully compare how people feel and function over 12 weeks, looking for improvements in these negative symptoms, and also keeping an eye on other aspects of health like thinking skills, day-to-day abilities, and any side effects. By doing this research, doctors hope to find more effective ways to help people recover well from their first experience with psychosis.

Key takeaways

The AMEND study explores a new treatment for negative symptoms in first-episode psychosis.
It tests memantine alongside standard care over 12 weeks.
Participants must be 18+ and experiencing their first episode of psychosis.
The study aims to improve understanding and treatment options for psychosis.
Participation involves regular assessments and careful medical monitoring.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. There is no upper age limit, meaning people of all adult ages can take part.

To be eligible, you must be experiencing your very first episode of psychosis. This means you haven't been diagnosed with or treated for psychosis before this current presentation.

Both men and women are welcome to participate in this research. The medical team will carefully check if this study is suitable and safe for you during an initial screening appointment.

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?
Are you currently experiencing your very first episode of psychosis?
Have you *not* been diagnosed or treated for psychosis before this current episode?
Are you able to attend regular appointments and assessments for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the AMEND study, you'll be assigned to either receive the study medicine (memantine) or a matching dummy pill (placebo), in addition to your regular care. Neither you nor your doctor will know which one you are getting. You'll take the study medication daily for 12 weeks.

Throughout these 12 weeks, you'll have regular appointments with the study team. These visits will involve answering questions about how you're feeling, your mood, your thoughts, and your daily life, using specific questionnaires. You'll also have checks on your memory and thinking skills. Some visits may involve blood tests and possibly brain scans to understand how the medicine is working. After the 12 weeks of treatment, there will likely be follow-up appointments to see how you are doing.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to medical knowledge that could help future patients with psychosis. You will also receive careful medical monitoring throughout the study. However, there's no guarantee that you will personally benefit from the memantine treatment, as it is still under investigation. Like all medicines, memantine can have side effects, and these will be explained to you in detail. There might also be side effects or discomfort from assessments like blood tests. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Denmark

Common questions

What are 'negative symptoms' of psychosis?

These are not about being negative-minded, but rather a lack of certain feelings or behaviours, like low motivation, reduced social interaction, or difficulty expressing emotions.

What is memantine and how does it work?

Memantine is a medicine that works on different brain chemicals than typical psychosis treatments. Researchers hope it might help improve negative symptoms.

Will I know if I'm getting memantine or a dummy pill?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving memantine or a placebo (dummy pill).

How long will I take part in the study?

You will take the study medicine for 12 weeks, with follow-up appointments afterwards. The total duration will be explained by the study team.

Can I stop participating in the study at any time?

Yes, you have the full right to withdraw from the study at any point, and your decision will not affect your ongoing medical care.