Actively Recruiting

Phase 4
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT07267559

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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