Actively Recruiting
An Investigation of the Effects of Dual Orexin Antagonism on Emotional Processing and Learning in Healthy Individuals
Led by University of Oxford · Updated on 2026-03-19
62
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how blocking the orexin system in the brain affects behavior and brain function in healthy adults. The focus is on daridorexant, a drug that inhibits orexin activity, which plays a role in sleep, emotions, motivation, and stress responses. This research aims to improve understanding of emotional and cognitive processes relevant to conditions like depression and anxiety by observing effects in a controlled setting. Participants will be randomly assigned to receive a single oral dose of either daridorexant 50 mg or a placebo in a double-blind design. After dosing, they will complete various behavioral and cognitive tasks that assess emotional processing, aversive learning, executive function, and other related functions. These tasks include the Pavlovian Aversive Learning Task and the Affective Go/No-Go Task, among others, conducted within a few hours after drug administration. During the study visit, participants will undergo computer-based assessments and biological measurements such as pupilometry and salivary alpha amylase levels to monitor changes after treatment. Researchers will evaluate computational parameters and behavioral performance on the tasks to understand the drug's impact. Participation involves a single visit with careful monitoring and adherence to study restrictions, such as avoiding alcohol and certain activities before and after the visit. The study is conducted in healthy volunteers aged 18 to 40 years.
CONDITIONS
Brief 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 eye glasses even if correction is usually worn
You will not qualify if you...
- History or treatment of any sleep or circadian rhythm disorder
- History or treatment of significant mental health conditions including schizophrenia, bipolar disorder, major depression, OCD, or PTSD
- Medical conditions increasing risk with daridorexant, including ADHD on stimulants, neurological problems, asthma or lung diseases, severe liver or kidney disease, severe gastrointestinal problems
- Pregnancy, breastfeeding, or intention to become pregnant during or within six months after the study
- Body mass index below 18 or above 30 kg/m2
- Current or past drug or alcohol dependency
- Regular alcohol use over 21 units per week or recent recreational drug use
- Excessive caffeine intake over 400 mg daily
- Smoking more than 5 cigarettes or equivalent nicotine use per day
- Recent use of medications affecting brain function except contraceptives
- Use of medications that may interact with daridorexant
- Inability to ingest up to 95 mg of lactose
- Participation in other drug or sleep studies in the past 3 months
- Participation in previous studies by the same lab or using the same tasks in the last 6 months
- Unlikely to comply or unsuitable for other reasons according to the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of either daridorexant or placebo and complete computer-based emotional and learning tasks to assess effects.
1 study visit (in-person) lasting several hours
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
D
Daniela A Borges, MD
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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