Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT07022366
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to give informed consent for participation in the research
* Aged 18-45 years
* Good vision and hearing
* Body mass index (BMI) within the range of 18-35kg/m2 (This is to ensure an appropriate pharmacokinetic profile for pimavanserin is achieved by all participants)
* Sufficiently fluent in English to understand tasks
* Willing to avoid drinking any alcohol the day before the research visit
Exclusion Criteria:
* Currently receiving or seeking treatment for any mental health condition
* Any past or current history of severe and/or serious psychiatric disorder, including but not limited to schizophrenia, psychosis, bipolar affective disorder, severe major depressive disorder, obsessive compulsive disorder (covered in SCID-5 assessment in screening procedures)
* ADHD requiring treatment with stimulant or other centrally-acting drugs
* Regular alcohol consumption of more than 21 units per week
* A head injury causing concussion or unconsciousness in the past 6 months
* Pregnancy / intention to become pregnant during the study or breastfeeding
* Any use of recreational drugs in the last three months
* Participation in any other drug study in the last three months
* Participation in any other study with the same tasks in the last year
* History of cardiac disease or cardiac arrhythmias
* Prolonged QTc interval on baseline ECG
* Current usage of other drugs known to prolong QT interval including Class 1A or 3 antiarrhythmics, e.g. certain antibiotics (getifloxacin, moxifloxacin)
* Current use of drugs that inhibit CYP3A4 (eg Clarithromycin. Diltiazem. Erythromycin. Fluconazole). Participants will be asked to avoid grapefruit juice in the week before the study.
* Current use of psychoactive medication that in the opinion of the Chief Investigator may interfere with the study measures
* 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, including epilepsy/seizures, brain injury, severe hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, severe neurological problems (e.g. Parkinson's disease; blackouts requiring hospitalisation);
* Any physical (including visual and auditory), cognitive or language impairment that would make complying with the study protocol challenging
* Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day;
* Smoking \>10 cigarettes per day; or equivalent nicotine consumption
* Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the chief investigator.
* Inability to ingest up to 95mg of lactose
Additional Exclusion Criteria for Participants in the Sleep Study Cohort:
* Unable to undergo cardiac monitoring
* Unable to wear the sleep patch device for full monitoring period
* Implanted neurostimulator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07022366
Study Brief:
Protocol Section:
NCT07022366