Pitolisant Effects on Affect and Cognition Exploratory Study (PEACE Study) (PEACE)
Anhedonia, Cognitive Function
About this trial
This is an interventional other trial for Anhedonia focused on measuring Drug, fMRI, pharmaco-fMRI, Cognition, Histamine
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the research Not currently taking any medications which may interfere with pitolisant, including psychoactive medications Not currently using antihistaminergic medication Aged 18-45 years Male or female Sufficiently fluent English to understand and complete cognitive tasks and questionnaires Body Mass Index above or below 18-30 Right handed Exclusion Criteria: Current pregnancy (as determined by urine pregnancy test taken during screening visit), planning to become pregnant or breast feeding Any past or current history of severe and/or serious psychiatric disorder, including but not limited to schizophrenia, psychosis, bipolar affective disorder, major depressive disorder, obsessive compulsive disorder Clinically significant abnormal values for urine drug screen, blood pressure measurement ( in accordance with AP20 'non-invasive blood pressure') and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere 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 the study, 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 3 months Participation in a study which uses the same computer tasks as those in the present study (determined by asking participants about previous studies participated in during screening) within past 3 months Participation in a study that involves the use of a medication within the last three months Smoking > 5 cigarettes per day Consumption of a high amount of caffeine per day (> 400ml caffeine) (e.g., 5 or more cups of coffee) Participant is unlikely to comply with the clinical study protocol or is unsuitable for 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
Sites / Locations
- Department of Psychiatry, University of OxfordRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pitolisant
Placebo
Two film-coated tablets (18mg x 2 [36mg]) for oral administration will be encapsulated in an opaque capsule.
Two lactose film-coated tablets (2 x 65mg [125mg]) will be encapsulated in an opaque capsule (identical to the experimental arm drug).