Losartan Effects on Emotion-memory Interaction

Healthy Clinical Trial

Official title:

The Role of the Renin-angiotensin System in Emotion-memory Interactions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04606225
• Other study ID #: UESTC-neuSCAN-74
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2020
• Source: University of Electronic Science and Technology of China
• Contact: Weihua Zhao, PhD
• Phone: 86-28-61830811
• Email: zarazhao.uestc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Losartan
administration of losartan (50 mg) (oral) Cozaar Oral Tablet
• Placebo Oral Tablet
administration of placebo (oral)

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI-based indices of neural activity during processing of emotional stimuli will be compared between the treatment groups	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.	120 to 150 minutes after treatment
Primary	fMRI-based indices of neural activity for subsequently successfully remembered as compared to non-remembered stimuli will be compared between the treatment groups	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.	120 to 150 minutes after treatment
Secondary	Self-Assessment Manikin (SAM) ratings of arousal of the stimuli will be compared between the treatment groups	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.	120 to 150 minutes after treatment
Secondary	Self-Assessment Manikin (SAM) ratings of valence of the stimuli will be compared between the treatment groups	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.	120 to 150 minutes after treatment
Secondary	Memory performance in terms of correctly recognized stimuli will be compared between the treatment groups	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.	24 hours after treatment