- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396523
Losartan and Emotion Processing
June 4, 2018 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Losartan Effects on the Extinction of Conditioned Fear in Humans
The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear
Study Overview
Detailed Description
In a double-blind, between-subject, placebo controlled design the effects of a single dose of losartan (50mg) on fear extinction in healthy male participants will be examined.
Participants will initially undergo a Pavlovian fear conditioning procedure, followed by the administration of 50mg losartan or placebo.
90 minutes after treatment subjects will undergo the fear extinction procedure.
Neural activity and psychophysiological indices of arousal will be assessed by the simultaneous acquisition of functional magnetic resonance imaging (fMRI) and skin conductance data.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology of China
-
Contact:
- Weihua Zhao, Master
- Phone Number: 611731
- Email: zarazhao.uestc@outlook.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy subjects without past or current psychiatric or neurological disorders
Exclusion Criteria:
- history of head injury
- medical or psychiatric illness
- hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo group
|
administration of placebo (oral)
|
Experimental: Losartan group
|
administration of losartan (50 mg) (oral)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Losartan effects on neural activity during fear extinction
Time Frame: 1 hour
|
Neural activity will be measured by functional magnetic resonance imaging (fMRI).
Effects of treatment will be evaluated by comparing extinction-related neural activity in the core extinction network (prefrontal cortex, limbic regions) between the active treatment and the placebo group.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Losartan effects on skin conductance responses during fear extinction
Time Frame: 1 hour
|
Effects of treatment will be evaluated by comparing extinction-related skin conductance responses between the active treatment and the placebo group.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin Becker, PhD, University of Electronic Science and Technology of China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2018
Primary Completion (Anticipated)
October 31, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 4, 2018
First Posted (Actual)
January 11, 2018
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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