A Phase 4 interventional study of Fenfluramine and Placebo in Cognitive Function, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by University of Oxford · Phase 4, Interventional, and Other
In this study, the investigators will investigate the cognitive effects of fenfluramine, a drug that directly stimulates the release of serotonin in the brain and positively modulates σ1 function. The investigators will use fenfluramine to assess the cognitive effects of modulating serotonin and σ1 function in healthy volunteers using a battery of cognitive tasks that measure learning and memory, executive functioning, reward processing, and emotional processing. The study design is double-blind, and participants will be randomised to either seven days of fenfluramine or placebo administration. All participants will attend two screening visits to assess eligibility. There are two main study visits; during the first, participants will undertake cognitive tasks and questionnaires before taking the initial study dose. One the second study visit, participants will once again complete these tasks and questionnaires after a week of fenfluramine/placebo administration.
University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Fenfluramine - 15mg twice daily oral solution for seven days
Drug: Fenfluramine
Placebo - 15mg twice daily oral solution for seven days
Other: Placebo
Fenfluramine (30mg daily) will be dispensed in a cherry flavoured aqueous solution. Fenfluramine is both a serotonin releasing agent and sigma-1 receptor agonist. Fenfluramine is FDA approved for the treatment of Dravet syndrome, a rare form of epilepsy.
Also known as: Fintepla (trade name), Fenfluramine Hydrochloride (ZX008)
The placebo is a liquid designed to be identical to the interventional drug fenfluramine in terms of both taste and visual appearance. It will be administered at 30mg daily and dispensed in a cherry flavoured aqueous solution
Change in Go/No-Go Task performance
Accuracy on the Go/No-Go task
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Change in Auditory Verbal Learning Task
Accuracy on AVLT (number of items recalled across blocks)
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Change in N-back task performance
Accuracy on the N-back task
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in reward sensitivity
Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task (PILT)
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in categorisation of emotional words
Accuracy to categorise positive and negative descriptor words
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in recall of emotional words
Number of words accurately recalled
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in recognition of emotional words
Number of words accurately recognised
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in recognition of emotional facial expressions
Accuracy of emotion labels (e.g. disgusted face) assigned by participants to expressive faces which have appeared on a computer screen for a period of 500ms.
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in visual short term memory on the Oxford Memory Test (OMT)
Accuracy on the Oxford Memory Task
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in visual search ability
Accuracy during contextual cueing task (CCT)
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Changes in control measures of subjective state
Ratings on the Positive and Negative Affect Schedule
Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data which has been fully de-identified may be shared with other academic and commercial organisations in the future, including those outside of the UK and the EU. Participants will be informed of this and specific consent to this is obtained within the Informed Consent Form.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Oxford