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New treatment option for Learning
Official title Dual Orexin Antagonism and Emotion and Affective Processing Study
ClinicalTrials.gov ID: NCT07267559
What this study is testing
What is Daridorexant 50 mg?
Daridorexant 50 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for learning.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Current Asthma, Chronic Obstructive Pulmonary Disease, emphysema or any medical condition that affects the lungs or breathing
See the full eligibility 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
- 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...
- 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
- 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.
- Body mass index (BMI) below 18 or above 30kg/m2.
- Current or past history of drug or alcohol dependency.
- 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.
- 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...
- Smoking more than 5 cigarettes per day (or other nicotine replacement equivalent, including vaping on average more than 50 puffs a day).
- 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...
- 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)
- Inability to ingest up to 95mg of lactose.
- Previous participation in any other drug study or sleep intervention study in the last three months.
- 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
- Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.