Dual Orexin Antagonism and Emotion and Affective Processing Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Oxford

About this trial

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.

Eligibility criteria

Qualifiers

Adult participant, aged 18 to 40 years

Willing and able to give informed consent for participation in the trial

Able to follow study procedures as laid out in the participant information sheet

Able to read and understand English

Disqualifiers

History of, receiving or seeking treatment for any sleep or circadian rhythm disorder or positive in screening questionnaires.

History of, receiving or seeking treatment for any clinically significant mental health condition (including but not limited to schizophrenia, psychosis, bipolar affective disorder, major depressive disorder, obsessive compulsive disorder, post-traumatic stress disorder) or positive in screening questionnaires.

ADHD requiring treatment with stimulants or other centrally-acting drugs

Neurological problems, including traumatic brain injury, epilepsy, Central Nervous System tumours or other severe neurological problems (e.g. Parkinson's disease; blackouts requiring hospitalisation)

Trial design

Treatments tested in this trial

  • Daridorexant 50 mg
  • Placebo

Treatment groups

62 Participants
are divided into 2 treatment groups

Sponsors and collaborators