Clinical trial NCT04508166: Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder
Official title: Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Thought
Psychological Trauma
Inflammatory Response
Physiological Stress
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.

Detailed description: The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.

Eligibility criteria: Inclusion Criteria:

* Speaks and understands German
* BMI 18.5 -\< 25
* Non-smoker status
* Habitual 5 or fewer alcoholic beverages / week
* Habitual 3 or fewer caffeinated beverages / day
* Habitual average sleep duration 7-9 h / night
* Normal or corrected-to-normal vision
* Insomnia Severity Index score between 8-14

Exclusion Criteria:

* Travel across 3 or more time zones within 3 months of study start
* Habitual napping
* Extreme chronotype, determined by Morningness-Eveningness Questionnaire
* History of or presence of a trauma- or stressor-related disorder
* History of or presence of neurological disorder, psychiatric disorder or head injury
* History of or presence of a sleep disorder
* History of or presence of cardiovascular disorder
* Use of illicit drugs
* Atypical preference for excessively violent portrayals
* Faints at the site of blood or brutality
* Has participated in a study \< 30 days or a study such as this (i.e., experimental trauma) at all.

Primary outcomes:
measure: Frequency of intrusive memories
timeFrame: Three weeks
measure: Emotional valence of intrusive memories
timeFrame: Three weeks
measure: Personal significance of intrusive memories
timeFrame: Three weeks
measure: Oscillatory delta power in the sleep electroencephalogram (EEG) during non rapid eye movement (REM) sleep stages N2 and N3
timeFrame: Four nights, each night a week apart, spanning one month
measure: Oscillatory theta power in the sleep electroencephalogram (EEG) during non rapid eye movement sleep stages N2 and N3
timeFrame: Four nights, each night a week apart, spanning one month
measure: EEG measures of sleep quality: distribution of N2 and N3 sleep stages.
timeFrame: Four nights, each night a week apart, spanning one month
measure: EEG measures of sleep quality: number of arousals
timeFrame: Four nights, each night a week apart, spanning one month
measure: EEG measures of sleep quality: sleep onset latency
timeFrame: Four nights, each night a week apart, spanning one month
measure: EEG measures of sleep quality: sleep duration
timeFrame: Four nights, each night a week apart, spanning one month
measure: EEG measures of sleep quality: sleep efficiency
timeFrame: Four nights, each night a week apart, spanning one month
Secondary outcomes:
measure: Physiological stress: circulating cortisol
timeFrame: Four nights, each morning a week apart, spanning one month
measure: Physiological stress: electrocardiogram (ECG) heart rate (HR)
timeFrame: Four nights, each night a week apart, spanning one month
measure: Physiological stress: respirometry respiration rate
timeFrame: Four nights, each night a week apart, spanning one month
measure: Physiological stress: electrocardiogram (ECG) heart rate variability (HRV)
timeFrame: Four nights, each night a week apart, spanning one month
measure: Physiological stress: inflammatory immune factors (cytokines and kynurenines)
timeFrame: Four mornings, each morning a week apart, spanning one month
measure: Subjective ratings of mood: Positive and Negative Affect Scale (PANAS)
timeFrame: Four nights, each night a week apart, spanning one month
measure: Subjective ratings of mood: State Trait Anxiety Inventory (STAI)
timeFrame: Four nights, each night a week apart, spanning one month
measure: Awakening response: cortisol
timeFrame: Four mornings, each morning a week apart, spanning one month
measure: Awakening response: Psychomotor Vigilance Task (PVT)
timeFrame: Four mornings, each morning a week apart, spanning one month
measure: Sleep inertia Questionnaire - Acute (SIQ - Acute)
timeFrame: Four mornings, each morning a week apart, spanning one month
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
state: Select An Option…
Study officials:
References: