Actively Recruiting
Dual Orexin Antagonism and Emotion and Affective Processing Study
Led by University of Oxford · Updated on 2026-03-19
62
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, the investigators will examine the effects of blocking the orexin system on human behaviour and brain function using daridorexant, a medication that inhibits orexin activity. Orexin is a brain chemical involved in regulating sleep, emotion, motivation, and stress responses, which are often disrupted in mental health disorders. Healthy volunteers will be randomly assigned to receive a single dose of daridorexant or placebo in a double-blind design. Participants will then complete behavioural and cognitive tasks assessing emotional processing, aversive learning, and executive function. The study aims to clarify the role of orexin in emotional and cognitive processes relevant to conditions such as depression and anxiety.
CONDITIONS
Official Title
Dual Orexin Antagonism and Emotion and Affective Processing Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 40 years
- Willing and able to give informed consent
- Able to follow study procedures as described
- Able to read and understand English
- Willing to avoid alcohol, recreational drugs, and grapefruit juice 24 hours before and after the study visit
- Willing to avoid driving or activities requiring full alertness until the morning after the study visit
- Able to complete computer tasks without wearing glasses even if correction is usually used
You will not qualify if you...
- History or treatment of sleep or circadian rhythm disorders
- History or treatment of major mental health conditions including schizophrenia, psychosis, bipolar disorder, major depressive disorder, OCD, PTSD
- Medical conditions increasing risk with daridorexant including ADHD treated with stimulants, neurological problems, lung diseases, liver impairment, severe kidney or gastrointestinal problems
- Pregnancy, intention to become pregnant, or breastfeeding during the study or following 6 months
- Body mass index below 18 or above 30 kg/m2
- Current or past drug or alcohol dependency
- Regular alcohol use above 21 units per week or recreational drug use in past 3 months
- Excessive caffeine intake above 400 mg daily
- Smoking more than 5 cigarettes or nicotine equivalent daily
- Current or recent (past 2 months) use of medications or devices affecting brain function except contraceptives
- Use of medications that interact with daridorexant including certain CYP3A inhibitors or inducers, gastric pH modifiers, and P-gp transporters
- Inability to ingest up to 95 mg of lactose
- Participation in other drug or sleep intervention studies in past 3 months
- Participation in related computer task studies in past 6 months
- Unlikely to comply with study protocol or unsuitable as judged by Investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Psychiatry, University of Oxford
Oxford, United Kingdom, OX3 7JX
Actively Recruiting
Research Team
M
Michael J Colwell, DPhil
CONTACT
D
Daniela A Borges, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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