RecruitingPHASE4INTERVENTIONAL

Dual Orexin Antagonism and Emotion and Affective Processing Study

This study is investigating a new medicine called daridorexant to understand how it affects human feelings, thinking, and behaviour. Scientists believe a brain chemical called orexin plays a key role in sleep, our emotions, how we're motivated, and how we handle stress. These areas are often affected in mental health conditions. Healthy volunteers will receive either daridorexant or a dummy pill (placebo) without knowing which one they have. They will then do computer tasks that check their emotions, learning abilities, and how they make decisions. By doing this, researchers hope to learn more about how orexin works, which could lead to improved treatments for conditions like depression and anxiety.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Oxford

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Oct 2026

Learning Cognitive Functioning Emotional Processing

What is this study about?

This research study is about understanding how a brain chemical called orexin affects our emotions, thinking, and general behaviour. Orexin is important for many things, including how well we sleep, our mood, what motivates us, and how we cope with stress. When these systems don't work properly, it can contribute to mental health issues like anxiety and depression.

The study uses a medicine called daridorexant, which works by blocking the effects of orexin. By giving healthy volunteers this medicine or a dummy pill, and then having them complete various tasks, the researchers can see what changes occur. These tasks will look at how people process emotions, how they learn, and how they make choices.

The main goal is to get a clearer picture of orexin's role in these areas. This knowledge is crucial because it could help scientists develop better ways to treat conditions where emotional and thinking processes are disrupted, potentially offering new hope for people living with depression and anxiety.

Key takeaways

Studies how a brain chemical called orexin affects emotions and thinking.
Uses a medication (daridorexant) or a dummy pill (placebo).
Aims to improve understanding of mental health conditions like anxiety and depression.
Healthy volunteers aged 18-40 are needed.
Involves computer tasks and a single study visit.
You cannot drink alcohol or drive after the visit until the next morning.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 40 years old. You should be able to understand the study information, give your permission to take part, and follow the instructions given by the study team. You'll also need to be able to read and understand English.

There are certain reasons why you might not be able to join. For example, if you have a history of sleep problems, certain mental health conditions like depression or anxiety, or if you're currently being treated for them, you likely won't be eligible. Also, certain medical conditions like severe lung, liver, or kidney problems, or if you've had issues like a stroke or severe head injury, would prevent you from taking part.

You also can't be pregnant or breastfeeding. The study team will ask you questions about your health to make sure it's safe for you 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 18 and 40 years old?
Do I have any history of sleep problems or mental health conditions like depression or anxiety?
Do I have any serious medical conditions affecting my lungs, liver, kidneys, or brain?
Am I pregnant or breastfeeding?
Can I avoid alcohol and recreational drugs for 24 hours before and after the study?
Will I be able to avoid driving or operating machinery until the next morning after the study visit?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the study medicine, daridorexant, or a look-alike dummy pill (placebo). Neither you nor the study team will know which one you've received. This is done to make sure the results are fair. You'll take a single dose of the medicine.

After taking the medicine, you will complete some computer-based tasks. These tasks are designed to check your emotions, how you learn, and your decision-making abilities. During the study period, you will need to avoid alcohol, recreational drugs, and grapefruit juice for 24 hours before and after your visit. You'll also need to avoid driving or doing anything that requires full alertness until the morning after your study visit. The study will involve a single visit to the research clinic and a follow-up period until the next morning.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could help others in the future by improving our understanding of certain brain chemicals and possibly leading to new treatments for conditions like anxiety and depression. As with any medication, there can be potential risks or side effects, which the study team will explain fully. These might include feeling drowsy or other temporary changes due to the medication. 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.

Department of Psychiatry, University of Oxford
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is orexin?

Orexin is a chemical in your brain that helps control things like when you sleep, your mood, how motivated you feel, and how your body responds to stress.

What does 'double-blind' mean?

It means neither you nor the doctors giving you the medicine will know if you're getting the active drug or a dummy pill. This helps keep the study fair.

Will I have to stay overnight?

The study involves a single visit, but you will need to avoid driving or doing anything that needs full attention until the morning after your study visit.

Can I drink alcohol during the study?

No, you'll need to avoid alcohol, recreational drugs, and grapefruit juice for 24 hours before and after your study visit.

What if I wear glasses for reading?

You should be able to complete the computer tasks without your glasses, even if you normally use them.

How to find out more

Michael J Colwell, DPhil

michael.colwell@psych.ox.ac.uk 01865 618200 Official trial record

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