7-day Simvastatin and Emotional Processing

NCT04652089 | Completed Phase 1

• 1 other identifier: R69606/RE001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Work in our group has revealed that short-term (7-day) administration of antidepressants produces positive biases in the processing of emotional information in healthy volunteers. Such effect might be an important neuropsychological mechanism of antidepressant action. The current study will investigate the effect of seven-day administration of simvastatin 20mg on emotional and reward processing tasks in healthy volunteers. There is evidence that statins may exert antidepressant effects via anti-inflammatory and anti-oxidant pathways, and it is therefore predicted that simvastatin will have positive effects on emotional and reward processing.

Conditions

Depression; Inflammation

Keywords

Depression; Inflammation

Outcome Measures

Primary Outcomes (1)

• FERT

  The effects of simvastatin on emotional processing using the Facial Expression Recognition Task (FERT). FERT is a computer-based tasks of emotional processing using facial expressions of basic emotions (happiness, fear, anger, disgust, sadness, surprise) displayed on the screen and participants are asked to correctly classify them. Each emotion is presented at different intensity levels. Responses are made via a button-press. Accuracy and reaction times are measured.

  Day 7 of drug/placebo administration

Secondary Outcomes (7)

• EMEM

  Day 7 of drug/placebo administration

• ECAT

  Day 7 of drug/placebo administration

• EREC

  Day 7 of drug/placebo administration

• FDOT

  Day 7 of drug/placebo administration

• PILT

  Day 7 of drug/placebo administration

Study Arms (2)

Experimental arm: Simvastatin

EXPERIMENTAL

Simvastatin 20mg capsule once a day for 7 days

Drug: Simvastatin 20mg

Control arm: Placebo

PLACEBO COMPARATOR

Placebo capsule once a day for 7 days

Drug: Placebo

Interventions

Simvastatin 20mg DRUG

Simvastatin 20mg once a day for 7 days

Experimental arm: Simvastatin

Placebo DRUG

Placebo once a day for 7 days

Control arm: Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Aged 18-50 years
• Sufficiently fluent English to understand and complete the tasks
• Body Mass Index in the range of 18-30
• Participant is willing and able to give informed consent for participation in the study
• Not currently taking any regular medications (except the contraceptive pill)

You may not qualify if:

• Currently any regular medications (except the contraceptive pill)
• History or current significant psychiatric illness
• Current alcohol or substance misuse disorder
• History or current significant hepatic disease
• History or current significant neurological condition (e.g. epilepsy)
• History of haemorrhagic stroke or lacunar infarct
• 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 as those used in the present study
• Participation in a study that involves the use of a medication within the last three months

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (1)

• De Giorgi R, Quinton AMG, Waters S, Cowen PJ, Harmer CJ. An experimental medicine study of the effects of simvastatin on emotional processing, reward learning, verbal memory, and inflammation in healthy volunteers. Psychopharmacology (Berl). 2022 Aug;239(8):2635-2645. doi: 10.1007/s00213-022-06156-y. Epub 2022 May 5.

  PMID: 35511258 DERIVED

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: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Participants will be randomly allocated to one of two groups (simvastatin or placebo) and take the assigned medication for 7 days

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: December 3, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 3, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)