NCT07267559 Dual Orexin Antagonism and Emotion and Affective Processing Study
| NCT ID | NCT07267559 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Oxford |
| Condition | Learning |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 62 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * Willing to avoid drinking alcohol, using recreational drugs, drinking grapefruit juice 24 hours before and after the study visit * Willing to avoid driving or engaging in any activities requiring full alertness (e.g. cycling or operating heavy machinery) until the morning after the study visit day. * Able to complete computer tasks without eye glasses even if uses correction regularly Exclusion Criteria: 1. History of, receiving or seeking treatment for any sleep or circadian rhythm disorder or positive in screening questionnaires. 2. 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. 3. History of, or current medical condition(s) which might increase the risk of oral administration of daridorexant, including: * 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) * Current Asthma, Chronic Obstructive Pulmonary Disease, emphysema or any medical condition that affects the lungs or breathing * Mild to severe hepatic impairment (Child-Pugh class A-C) * Severe renal disease * Severe gastrointestinal problems * History of, or current medical condition(s) which, in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study 4. Pregnancy (as determined by urine pregnancy test taken during screening visit), intention to become pregnant or breastfeeding during the study or over the following six months. 5. Body mass index (BMI) below 18 or above 30kg/m2. 6. Current or past history of drug or alcohol dependency. 7. Regular alcohol consumption of more than 21 units per week or use of recreational drugs or performance-enhancing drugs (e.g. cannabis, cocaine, amphetamines) within past three months. 8. Excessive caffeine consumption, i.e., consumption higher than 400mg a day of caffeine. This corresponds to more than 4 cups of brewed coffee, 6 espressos or filtered coffees, 9 cups of black tea, 10 cans of cola, or two "energy shot" drinks. 9. Smoking more than 5 cigarettes per day (or other nicotine replacement equivalent, including vaping on average more than 50 puffs a day). 10. Current or recent (past two months) use of any medication or medical devices (e.g. implanted neurostimulator) that affect brain function for the exception of contraceptives (pill, the Depo-Provera injection or the progesterone implant). This includes drugs that cause sedation (e.g. benzodiazepines, opioids, tricyclic antidepressants or sedative antipsychotics) or antihistamines. 11. Current use of any medications at risk of interaction with daridorexant; in particular: * strong or moderate CYP3A inhibitors (e.g. strong inhibitors - itraconazole, clarithromycin, ritonavir, grapefruit juice; moderate inhibitors - fluconazole, verapamil, diltiazem, erythromycin, ciprofloxacin, cyclosporine) * strong or moderate CYP3A inducers (e.g. of strong inducers - rifampicin, carbamazepine, St. John's wort; moderate inducers - bosentan, efavirenz, etravirine, modafinil) * Gastric pH-modifiers (e.g. famotidine and proton pump inhibitors such as omeprazole) * P-gp transporters (e.g. dabigatran, digoxin) 12. Inability to ingest up to 95mg of lactose. 13. Previous participation in any other drug study or sleep intervention study in the last three months. 14. Previous participation in any other study by the Psychopharmacology and Emotion Research lab (Department of Psychiatry, University of Oxford) or which uses the same computer tasks in the last 6 months 15. Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
Contact & Investigator
Catherine J Harmer, DPhil
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT07267559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Learning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07267559 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07267559 currently recruiting?
Yes, NCT07267559 is actively recruiting participants. Contact the research team at michael.colwell@psych.ox.ac.uk for enrollment information.
Where is the NCT07267559 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07267559 clinical trial?
NCT07267559 is sponsored by University of Oxford. The principal investigator is Catherine J Harmer, DPhil at University of Oxford. The trial plans to enroll 62 participants.