Losartan Effects on Emotion-memory Interaction

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Placebo Oral Tablet; Drug: Losartan

• Registration Number: NCT04606225
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

The purpose of this study is to investigate whether a single dose of losartan (50 mg) can affect emotion-memory interaction in healthy humans and its underlying neural mechanisms.

Detailed Description

Animal models and initial findings in humans suggest a role of the renin-angiotensin system in cognitive and emotional processes. Accumulating evidence demonstrates modulatory effects of the angiotensin antagonist losartan in the domains of memory and emotional processing. Against this background the present study aims to investigate the behavioral and neural effects of a single dose of losartan on emotional processing and emotion-memory integration in healthy subjects. In a double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment, 60 male participants will be randomized to a single dose of losartan (50 mg) or placebo, and encode emotional pictures during fMRI (scheduled 90 minutes after drug administration). Then 24 hours post fMRI participants will finish a surprise recognition memory test to estimate the emotion effects on subsequent memory.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-09
• Study Start: 2020-10-10
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Healthy subjects without past or current psychiatric or neurological disorders
• Right-handedness
• Normal or corrected-normal version

Exclusion Criteria

• History of head injury
• Medical or psychiatric illness
• Hypertension
• General cardio-vascular alteration or diseases
• Allergy against medications
• Visual or motor impairments
• Claustrophobia
• Drug addiction
• Nicotine dependence
• FMRI contradictions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo Oral Tablet	Drug: Placebo Oral Tablet
Losartan group	Losartan	Drug: Losartan

Primary Outcome Measures

Name	Time	Method
fMRI-based indices of neural activity during processing of emotional stimuli will be compared between the treatment groups	120 to 150 minutes after treatment	Neural activation during processing of emotional pictures will be assessed by functional magnetic resonance imaging (fMRI). The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.
fMRI-based indices of neural activity for subsequently successfully remembered as compared to non-remembered stimuli will be compared between the treatment groups	120 to 150 minutes after treatment	Neural activation for stimuli that are successfully remembered after an interval of 24hours will be compared to stimuli that are not successfully remembered. Neural activity between the subsequently remembered and non-remembered stimuli will be assessed by functional magnetic resonance imaging (fMRI) acquired during the initial encoding of the stimuli. The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.

Secondary Outcome Measures

Name	Time	Method
Self-Assessment Manikin (SAM) ratings of arousal of the stimuli will be compared between the treatment groups	120 to 150 minutes after treatment	During the fMRI participants will rate the emotional arousal of each presented picture by means of the Self-Assessment Manikin (SAM). The assessment ranges from 1-5, with 1 referring to very low arousal while 5 refers to a very high arousal. The effects of treatment on arousal will be examined by comparing the losartan-treated with the placebo-treated group by means of a Generalized Linear Model approach.
Self-Assessment Manikin (SAM) ratings of valence of the stimuli will be compared between the treatment groups	120 to 150 minutes after treatment	During the fMRI participants will rate the emotional valence of each presented picture by means of the Self-Assessment Manikin (SAM). The assessment ranges from 1-5, with 1 referring to very negative valence, while 5 refers to a very positive valence. The effects of treatment on valence will be examined by comparing the losartan-treated with the placebo-treated group by means of a Generalized Linear Model approach.
Memory performance in terms of correctly recognized stimuli will be compared between the treatment groups	24 hours after treatment	24 hours after the fMRI assessment subjects will be re-exposed to the stimuli that were presented during the fMRI and new stimuli. Subjects have to indicate for each stimulus whether it has been shown during fMRI. Memory performance in terms of correct responses will be computed and compared between the losartan-treated with the placebo-treated group by means of a Generalized Linear Model approach.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China