Phase
Condition
Brain Function
Treatment
Placebo
Pitolisant 17.8 MG [Wakix]
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is willing and able to give informed consent for participation in theresearch
Not currently taking any medications which may interfere with pitolisant, includingpsychoactive medications
Not currently using antihistaminergic medication
Aged 18-45 years
Male or female
Sufficiently fluent English to understand and complete cognitive tasks andquestionnaires
Body Mass Index above or below 18-30
Right handed
Exclusion
Exclusion Criteria:
Current pregnancy (as determined by urine pregnancy test taken during screeningvisit), planning to become pregnant or breast feeding
Any past or current history of severe and/or serious psychiatric disorder, includingbut not limited to schizophrenia, psychosis, bipolar affective disorder, majordepressive disorder, obsessive compulsive disorder
Clinically significant abnormal values for urine drug screen, blood pressuremeasurement ( in accordance with AP20 'non-invasive blood pressure') and ECG. Aparticipant with a clinical abnormality or parameters outside the reference rangefor the population being studied may be included only if the Investigator considersthat the finding is unlikely to introduce additional risk factors and will notinterfere with the study procedures
History of, or current medical conditions which, in the opinion of the investigator,may interfere with the safety of the participant or the scientific integrity of thestudy, including epilepsy/seizures, brain injury, hepatic or renal disease,acid-related gastro-intestinal problems, Central Nervous System (CNS) tumours,neurological conditions
Current or past history of drug or alcohol dependency
Severe lactose intolerance
Use of recreational drugs (e.g. cannabis, cocaine, amphetamines) within past 3months
Participation in a study which uses the same computer tasks as those in the presentstudy (determined by asking participants about previous studies participated induring screening) within past 3 months
Participation in a study that involves the use of a medication within the last threemonths
Smoking > 5 cigarettes per day
Consumption of a high amount of caffeine per day (> 400ml caffeine) (e.g., 5 or morecups of coffee)
Participant is unlikely to comply with the clinical study protocol or is unsuitablefor any other reason, in the opinion of the Investigator
Any contraindication to MRI scanning (e.g. metal objects inside the body,pacemakers, significant claustrophobia)
Not right handed
Study Design
Study Description
Connect with a study center
Department of Psychiatry, University of Oxford
Oxford,
United KingdomSite Not Available
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