FearPhase 1NCT02673606
Impact of Estrogen on Fear Extinction R61
A Phase 1 study testing Estradiol 2Mg Tablet and Estradiol 4Mg Tablet in people with Fear and Fear; Examination, Phobic, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear, Fear; Examination, Phobic
- What is being tested?
- Estradiol 2Mg Tablet and Estradiol 4Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 15 Apr 2019
- Phase
- Phase 1
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed (Edinburgh Inventory - Oldfield 1971).
- SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.
- To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
- For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.
- For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic
Who cannot join
- Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
- History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
- History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.
- Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
- Pregnancy (to be ruled out by urine ß-HCG).
- Metallic implants or devices contraindicating magnetic resonance imaging.
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- Use of oral contraceptives or non-oral contraceptives containing estrogen and progesterone within 3 months
- History of breast cancer.
- Allergy to peanut oil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Estrogen on the Fear Extinction Network in Humans-R61
The goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network.
Read the detailed description
The aim of the study was to examine the influence of exogenous estrogen administration on the activation of the fear extinction network in women. Functional MRI data and psychophysiological indices were collected to test the influence of estrogen on women's ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm using classical fear conditioning. The first day was conducted outside the scanner, while days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before extinction learning test on day 2. No followups were conducted after women completed the 3 day study.
- Conditions
- Fear, Fear; Examination, Phobic
- Being tested
- Estradiol 2Mg Tablet, Estradiol 4Mg Tablet, Placebo Pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol 2Mg TabletDrug
Also called Estrace® Tablets
one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
Estradiol 4Mg TabletDrug
Also called Estrace® Tablets
two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
Placebo PillsDrug
Also called Estrace® Tablets
inactive placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Estradiol 2mg Dose | Experimental | 2mg dose of estradiol (oral administration) Receives: Drug: Estradiol 2Mg Tablet |
| Estradiol 4mg Dose | Experimental | 4mg dose of estradiol (oral administration) Receives: Drug: Estradiol 4Mg Tablet |
| Placebo | Placebo comparator | placebo (oral administration) Receives: Drug: Placebo Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of exogenous administration of estradiol on the neural correlates of fear extinction
BOLD responses during fear extinction after taking estradiol or placebo
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2013
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Milad, PhD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673606
- Sponsor's protocol ID
- 2007P000496
- Status last verified
- Jul 2020
- First submitted
- 26 Jan 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Estrogen on the Fear Extinction Network in Humans-R61
- ClinicalTrials.gov ID
- NCT02673606
- Acronym / sponsor ID
- 2007P000496
- Conditions
- Fear, Fear; Examination, Phobic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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 goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network.
Detailed description
The aim of the study was to examine the influence of exogenous estrogen administration on the activation of the fear extinction network in women. Functional MRI data and psychophysiological indices were collected to test the influence of estrogen on women's ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm using classical fear conditioning. The first day was conducted outside the scanner, while days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before extinction learning test on day 2. No followups were conducted after women completed the 3 day study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol 2mg Dose | Experimental | Drug: Estradiol 2Mg Tablet2mg dose of estradiol (oral administration) |
| Estradiol 4mg Dose | Experimental | Drug: Estradiol 4Mg Tablet4mg dose of estradiol (oral administration) |
| Placebo | Placebo comparator | Drug: Placebo Pillsplacebo (oral administration) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right-handed (Edinburgh Inventory - Oldfield 1971).
- SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.
- To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
- For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.
- For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic
Key exclusion criteria (9 listed)
- Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
- History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
- History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.
- Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
- Pregnancy (to be ruled out by urine ß-HCG).
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 |
|---|---|---|
| Estradiol 2Mg TabletAlso: Estrace® Tabletsone 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott), | Drug | Estradiol 2mg Dose |
| Estradiol 4Mg TabletAlso: Estrace® Tabletstwo 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott), | Drug | Estradiol 4mg Dose |
| Placebo PillsAlso: Estrace® Tabletsinactive placebo pills | Drug | Placebo |
Primary outcome
Impact of exogenous administration of estradiol on the neural correlates of fear extinction
Time frame: 3 Days
BOLD responses during fear extinction after taking estradiol or placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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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.
Mohammed Milad, PhD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estradiol 2Mg Tablet and Estradiol 4Mg Tablet in people with Fear and Fear; Examination, Phobic, run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jul 2020. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of exogenous administration of estradiol on the neural correlates of fear extinction (time frame: 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020.