Intrusion, Intrusion Symptom, Intrusive Memories, PTSD, Trauma
Conditions
Keywords
Trauma film, Estradiol, ptsd, intrusive memories, intrusion, estrogen
Brief summary
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.
Interventions
DRUGEstradiol Valerate
3mg of Estradiol Valerate pills, administred orally
DRUGPlacebo
Plabo pill
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind, randomized, placebo controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Intrusive Memories in the following four days after the intervention | four consecutive days | Influence of estradiol on the development of intrusive memories measured with an intrusion diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noradrenergic System (measured with salivary alpha-amylase - u/ml) | Day 1 | Influence of noradrenergic system measured with salivary alpha-amylase on the development of intrusive memories |
| Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) | Day 1 | Influence of HPA-axis measured with salivary cortisol on the development of intrusive memories |
| Estradiol and Progesterone | Day 1 | Influence of salivary endogenous estradiol and progesterone on the development of intrusive memories. |
| heart rate variability | Day 1 | Influence of heart rate variability on the development of intrusive memories |
Countries
Germany
Contacts
CONTACTTolou Maslahati, M.Sc.
PRINCIPAL_INVESTIGATORKatja Wingenfeld, Prof. Dr.
Charite University, Berlin, Germany
PRINCIPAL_INVESTIGATORStefan Roepke, Prof. Dr.
Charite University, Berlin, Germany
Outcome results
None listed