Viewing Study NCT06636812



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06636812
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-23

Brief Title: Losartan and Emotional Processing in Young People
Sponsor: None
Organization: None

Study Overview

Official Title: The Effects of Single-dose Losartan on the Processing of Emotional Information in Healthy Adolescents a Randomised Controlled Study
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study explores the effects of single-dose losartan 50mg versus placebo on emotional processing in young healthy volunteers
Detailed Description: Compared to children and adults adolescents are most likely to develop an anxiety disorder and less likely to respond to even the most effective treatment - exposure therapy Similarly fear extinction - the laboratory equivalent to exposure therapy - is impaired in this young age group Animal and human research suggests that such deficits in fear reduction may be underpinned by insufficient functioning of the ventromedial prefrontal cortex vmPFC during adolescence as part of normative development

A single dose of losartan a commonly prescribed blood pressure drug targeting the renin-angiotensin system has been shown to enhance fear extinction in adult humans Zhou et al 2019 Most importantly such effects are seen to be driven by improved vmPFC function following losartan Zhou et al 2019 Our own work in adults has also demonstrated rapid beneficial effects of single-dose losartan on other neurocognitive markers relevant to anxiety and treatment response while not revealing any adverse reactions Reinecke et al 2018 Pulcu et al 2019 Shkreli et al 2020 These findings suggest that the renin-angiotensin system plays a key role in the extinction of anxiety and that adding losartan to exposure therapy for anxiety in humans might have synergistic effects

In this double-blind randomized between-group study we will investigate the effects of a single dose of losartan weight-adjusted 50mg if over 25mg if below 50kg versus placebo on emotional processing in N60 healthy volunteers aged 16-20 years One hour later when drug-peak plasma levels are reached participants will work on a battery of computerized tasks including a fear extinction task and other tasks exploring attention for and learning from neutral and emotional stimuli of differing valence Results from this study will help us understand how the renin-angiotensin system affects emotional processing in human adolescents and they will help us identify potential synergistic overlaps with the cognitive mechanisms of effective exposure therapy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None