Health TrialsbyHealthPanel

Estradiol and Intrusive Memories

ConditionsPTSDIntrusive MemoriesIntrusion SymptomTraumaIntrusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy female volunteers

German on B1 level

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Estradiol Valerate

    Drug

    3mg of Estradiol Valerate pills, administred orally

  • Placebo

    Drug

    Plabo pill

Treatment groups

273 Participants
are divided into 3 treatment groups
Group A: Estradiol before the trauma paradigmeExperimental treatment 1 intervention
Group B: Estradiol after the trauma paradigmeExperimental treatment 1 intervention
Group C: Placebo before and after the trauma film paradigmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Intrusive Memories in the following four days after the intervention

Influence of estradiol on the development of intrusive memories measured with an intrusion diary

Time frame
four consecutive days

Secondary outcomes

1

Noradrenergic System (measured with salivary alpha-amylase - u/ml)

Influence of noradrenergic system measured with salivary alpha-amylase on the development of intrusive memories

Time frame
Day 1
2

Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)

Influence of HPA-axis measured with salivary cortisol on the development of intrusive memories

Time frame
Day 1
3

Estradiol and Progesterone

Influence of salivary endogenous estradiol and progesterone on the development of intrusive memories.

Time frame
Day 1
4

heart rate variability

Influence of heart rate variability on the development of intrusive memories

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Source ClinicalTrials.gov
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