Simvastatin and Emotional Processing (OxSTEP)

NCT04973800 | Completed

• 1 other identifier: R73946/RE001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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'.

Conditions

Depression; Inflammation

Outcome Measures

Primary Outcomes (2)

• Facial expression recognition task (FERT)

  Accuracy on a computer-based task of emotional processing (i.e. Facial expression recognition task \[FERT\]), comparing those receiving drug and placebo.

  Day 28-30 of drug/placebo administration

• Facial expression recognition task (FERT)

  Reaction times on a computer-based task of emotional processing (i.e. Facial expression recognition task \[FERT\]), comparing those receiving drug and placebo.

  Day 28-30 of drug/placebo administration

Secondary Outcomes (9)

• Emotional categorisation task (ECAT)

  Day 28-30 of drug/placebo administration

• Emotional categorisation task (ECAT)

  Day 28-30 of drug/placebo administration

• Emotional recall task (EREC)

  Day 28-30 of drug/placebo administration

• Emotional recall task (EREC)

  Day 28-30 of drug/placebo administration

• Probabilistic instrumental learning task (PILT)

  Day 28-30 of drug/placebo administration

Study Arms (2)

Experimental arm: Simvastatin

EXPERIMENTAL

Simvastatin 20mg ON PO for 28-30 days

Drug: Simvastatin 20mg

Control arm: Placebo

PLACEBO COMPARATOR

Sucrose placebo ON PO for 28-30 days

Drug: Placebo

Interventions

Simvastatin 20mg DRUG

Simvastatin 20mg ON PO for 28-30 days

Experimental arm: Simvastatin

Placebo DRUG

Sucrose placebo ON PO for 28-30 days

Control arm: Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 21-65 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression; Inflammation

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The simvastatin and the placebo tablets will be sourced from the Oxford Pharmacy Stores and HSC (www.hsconline.co.uk) respectively, and will be encapsulated at the Neurosciences Building according to our standard operating procedure (APPENDIX D: Neurosciences, SOP Number: Encapsulation Version 2: 22.10.2012). Blinding will be achieved by the identical matching of the simvastatin and placebo treatments. Participants will not be aware of the treatment that they will be receiving; neither will the researchers, as this study is double-blind. Allocation of treatments will be recorded on a randomisation list, which will be updated when each new participant enters the randomised phase. The list will be held at the Neurosciences Building by a scientist uninvolved in the study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 22, 2021
• Study Start: July 5, 2021
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: June 26, 2024

Record last verified: 2022-08

Locations

GB (1)