HealthyNCT03396523
Losartan and Emotion Processing
A study testing Losartan in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- history of head injury
- medical or psychiatric illness
- hypertension
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Weihua Zhao, Master, 611731, zarazhao.uestc@outlook.com
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- Losartan, Placebo Oral Tablet
- Keywords
- Losartan, Fear extinction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar Oral Tablet
administration of losartan (50 mg) (oral)
Placebo Oral TabletDrug
administration of placebo (oral)
| Study group | Role | What they receive |
|---|---|---|
| Losartan group | Experimental | Not described Receives: Drug: Losartan |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Losartan effects on neural activity during fear extinction
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.
Measured: 1 hour
Secondary outcomes (1)
Losartan effects on skin conductance responses during fear extinction
Effects of treatment will be evaluated by comparing extinction-related skin conductance responses between the active treatment and the placebo group.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start4 Jan 2018
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396523
- Sponsor's protocol ID
- UESTC-neuSCAN-25
- Status last verified
- Jun 2018
- First submitted
- 4 Jan 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou F, Geng Y, Xin F, Li J, Feng P, Liu C, Zhao W, Feng T, Guastella AJ, Ebstein RP, Kendrick KM, Becker B. Human Extinction Learning Is Accelerated by an Angiotensin Antagonist via Ventromedial Prefrontal Cortex and Its Connections With Basolateral Amygdala. Biol Psychiatry. 2019 Dec 15;86(12):910-920. doi: 10.1016/j.biopsych.2019.07.007. Epub 2019 Jul 25.
PubMed 31471037
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan Effects on the Extinction of Conditioned Fear in Humans
- ClinicalTrials.gov ID
- NCT03396523
- Acronym / sponsor ID
- UESTC-neuSCAN-25
- Conditions
- Healthy
- Keywords
- Losartan, Fear extinction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan group | Experimental | Drug: Losartan |
| Placebo group | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- history of head injury
- medical or psychiatric illness
- hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: Cozaar Oral Tabletadministration of losartan (50 mg) (oral) | Drug | Losartan group |
| Placebo Oral Tabletadministration of placebo (oral) | Drug | Placebo group |
Primary outcome
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 secondary outcome
Losartan effects on skin conductance responses during fear extinction
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 31471037Zhou F, Geng Y, Xin F, Li J, Feng P, Liu C, Zhao W, Feng T, Guastella AJ, Ebstein RP, Kendrick KM, Becker B. Human Extinction Learning Is Accelerated by an Angiotensin Antagonist via Ventromedial Prefrontal Cortex and Its Connections With Basolateral Amygdala. Biol Psychiatry. 2019 Dec 15;86(12):910-920. doi: 10.1016/j.biopsych.2019.07.007. Epub 2019 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Becker, PhD principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weihua Zhao, Master (86-28-61830811, zarazhao.uestc@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Losartan effects on neural activity during fear extinction (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.