Simvastatin and Emotional Processing (OxSTEP)

• Status: Recruiting
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

Summary

Simvastatin is being employed because it is a 'statin'. As a drug class, statins have broad anti-inflammatory properties. Low-level inflammation is thought to be a potentially important mediator of the effects of psychosocial stress (including loneliness) on affect and vulnerability to depression. In this study we are using statins as an experimental tool to investigate this relationship further. Statins are widely prescribed agents that are regarded as very safe and so are suitable tools in this context. We have selected simvastatin because it is one of the most widely used statins and has an excellent safety profile, being also available 'over the counter'.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oxford
• Collaborator: Wellcome Trust
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Male or female

• Age 30-60 years

• At-risk for depression as measured by a score >6 on the UCLA 3-item Loneliness Scale

• Body Mass Index in the range of 18-30

• Willing and able to give informed consent for participation in the study

• Registered with a GP and consenting to GP being informed of participation in the study

• Currently living in the UK and sufficiently fluent English to understand and complete the tasks

• Able to access and use a computer with Internet

• Able to complete online questionnaires and tasks

Exclusion Criteria:

• Currently on any regular prescribed medications (except the contraceptive pill), unless unlikely to compromise safety or affect data quality in the opinion of the Investigator;

• History or current significant psychiatric illness (other than past [>6 months] episodes of depression or anxiety)

• Current alcohol or substance misuse disorder (< 6 months)

• History of, or current significant hepatic disease

• History of, or current significant neurological condition (e.g. epilepsy)

• History of haemorrhagic stroke or deep brain structures stroke

• Known hyperglycaemia/pre-diabetes

• Known hypersensitivity to the study drug (i.e. simvastatin) or sucrose

• Pregnant, breast feeding, women of child-bearing potential not using appropriate contraceptive measures

• Participation in a study that uses the same or similar computer tasks (apart from the N-back) as those used in the present study

• Participation in a study that involves the use of a medication within the last 3 months