- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419594
Estradiol and Intrusive Memories (EstraMemo)
The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories
The aim of the current project is to investigate the impact of 3mg of oral estradiol valerate on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of oral estradiol on intrusive symptoms during and immediately after exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral estradiol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tolou Maslahati, M.Sc.
- Phone Number: 0049 30 450 517 567
- Email: tolou.maslahati@charite.de
Study Locations
-
-
State of Berlin
-
Berlin, State of Berlin, Germany, 12203
- Recruiting
- Charité - Universitätsmedizin Berlin
-
Contact:
- Tolou Maslahati, M.Sc.
- Phone Number: +49 30 450 517567
- Email: tolou.maslahati@charite.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy female volunteers
- German on B1 level
Exclusion Criteria:
- former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
- any physical illnesses
- any medication intake (except oral contraceptive)
- history of traumatic experience, e.g. history of sexual abuse or rape
- pregnancy or lactation period
- intake of oral contraceptives
- follicular phase of menstrual cycle
Study Plan
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 before and after the trauma film paradigm
|
Plabo pill
|
|
Experimental: Estradiol before the trauma paradigme
3mg of oral estradiol valerate administered two hours before the trauma film (during acquisition of trauma associated memories)
|
3mg of Estradiol Valerate pills, administred orally
|
|
Experimental: Estradiol after the trauma paradigme
3mg of oral estradiol valerate administered immediately after the trauma film (during consolidation of trauma associated memories)
|
3mg of Estradiol Valerate pills, administred orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Intrusive Memories in the following four days after the intervention
Time Frame: four consecutive days
|
Influence of estradiol on the development of intrusive memories measured with an intrusion diary
|
four consecutive days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Time Frame: Day 1
|
Influence of noradrenergic system measured with salivary alpha-amylase on the development of intrusive memories
|
Day 1
|
|
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Time Frame: Day 1
|
Influence of HPA-axis measured with salivary cortisol on the development of intrusive memories
|
Day 1
|
|
Estradiol and Progesterone
Time Frame: Day 1
|
Influence of salivary endogenous estradiol and progesterone on the development of intrusive memories.
|
Day 1
|
|
heart rate variability
Time Frame: Day 1
|
Influence of heart rate variability on the development of intrusive memories
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Katja Wingenfeld, Prof. Dr., Charite University, Berlin, Germany
- Principal Investigator: Stefan Roepke, Prof. Dr., Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Mental Disorders
- Stress Disorders, Traumatic
- Wounds and Injuries
- Stress Disorders, Post-Traumatic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Estrenes
- Estranes
- Estradiol Congeners
- Gonadal Steroid Hormones
- Gonadal Hormones
- Estradiol
Other Study ID Numbers
- EstraMe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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