Losartan Effects on Emotion-memory Interaction

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04606225
Collaborator
(none)
60
1
2
17.6
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Role of the Renin-angiotensin System in Emotion-memory Interactions
Actual Study Start Date :
Oct 10, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Losartan group

Drug: Losartan

Drug: Losartan
administration of losartan (50 mg) (oral) Cozaar Oral Tablet
Other Names:
  • Cozaar Oral Tablet
  • Placebo Comparator: Placebo group

    Drug: Placebo Oral Tablet

    Drug: Placebo Oral Tablet
    administration of placebo (oral)

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Electronic Science and Technology of China Chengdu Sichuan China 611731

    Sponsors and Collaborators

    • University of Electronic Science and Technology of China

    Investigators

    • Principal Investigator: Benjamin Becker, PhD, University of Electronic Science and Technology of China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin Becker, Professor, University of Electronic Science and Technology of China
    ClinicalTrials.gov Identifier:
    NCT04606225
    Other Study ID Numbers:
    • UESTC-neuSCAN-74
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Benjamin Becker, Professor, University of Electronic Science and Technology of China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2020