Fenfluramine and Cognition (FEN&Cognition)

University of Oxford

Status and phase

Completed

Phase 4

Conditions

Cognitive Function

Treatments

Other: Placebo

Drug: Fenfluramine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05026398

FenCog

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 22 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant is willing and able to give informed consent for participation in the research
Not currently taking any medications (except the contraceptive pill)
Aged 18-22 years
Male or female
Sufficiently fluent English to understand and complete the task
Body Mass Index above 18-30
Weight of 40-75kg

Exclusion criteria

Current pregnancy (as determined by urine pregnancy test taken during Screening and First Dose Visit) or breast feeding
Any past or current Axis 1 DSM-V psychiatric disorder
Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement 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, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
Current or past history of drug or alcohol dependency
Current or past use of 3,4-Methylenedioxymethamphetamine (MDMA)
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)
Participation in a study that involves the use of a medication within the last three months
Smoking > 5 cigarettes per day
Typically drinks > 6 caffeinated drinks per day (e.g. tea, coffee, coca cola, Red Bull)
Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator