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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Daridorexant 50 mg
DrugAcute (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 interventionLactose film-coated tablet will be encapsulated in an opaque capsule (identical to the experimental arm drug).
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: DaridorexantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pavlovian Aversive Learning Task Computational Parameter Estimates
Change in the participant-specific parameter estimates produced by task model fitting.
Time frame
1-2 hours after single dose of drug or placebo.2
Affective Go/No-Go Task Computational Parameter Estimates
Change in the participant-specific parameter estimates produced by task model fitting.
Time frame
1-2 hours after single dose of drug or placebo.Secondary outcomes
1
Pupilometry during Pavlovian Aversive Learning Task
Changes in pupil size (dilation or constriction) in response to task stimuli
Time frame
1-2 hours after single dose of drug or placebo.2
Pupilometry during Affective Go/No-Go Task
Changes in pupil size (dilation or constriction) in response to task stimuli.
Time frame
1-2 hours after single dose of drug or placebo.3
Salivary Alpha Amylase Levels
Changes in Salivary Alpha Amylase Levels before, during and after Pavlovian Aversive Learning Task
Time frame
1-2 hours after single dose of drug or placebo.4
Optimal choice selection during loss and reward conditions in Probabilistic Instrumental Learning Task (PILT)
Optimal choice selection during loss and reward conditions in Probabilistic Instrumental Learning Task (PILT) in drug group compared with the placebo group
Time frame
2-3 hours after single dose of drug or placebo.Sponsors and contacts
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Source ClinicalTrials.gov