Dual Orexin Antagonism and Emotion and Affective Processing Study

Sponsor
University of Oxford
Study ID
NCT07267559
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cognitive Functioning
  • Emotional Processing
  • Learning

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Daridorexant 50 mg — DRUG
    Acute (single dose) daridorexant encapsulated in an opaque capsule. Oral administration. Daridorexant (brand name Quviviq) is FDA-approved for the treatment of insomnia in adults.
  • Placebo — OTHER
    Lactose film-coated tablet will be encapsulated in an opaque capsule (identical to the experimental arm drug).

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Daridorexant
    Acute daridorexant (50mg)
  • Placebo Comparator: Placebo
    Inactive placebo comparator

Primary Outcome Measure

Pavlovian Aversive Learning Task Computational Parameter Estimates [ Time Frame: 1-2 hours after single dose of drug or placebo. ]

Central Contacts

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