We aim to lay the fundament of novel interventions by gaining an in-depth comprehensive understanding of individual differences in the overnight adaptation of emotional memory and malleability thereof by noradrenergic modulation.
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
insomnia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the overnight resolution of recent emotional
distress (the karaoke task) as measured by a subjective question (how
embarrassed do you feel by this fragment), as well as by heart rate derived
from electrocardiography.
Secondary outcome
We will include the other autonomic responses on the karaoke task: galvanic
skin responses, blushing response and facial electromyography, as well as
subjective ratings of valence and arousal.
The overnight resolution of long-lived distress (autobiographical memory task)
will also be used as secondary study parameter, including the same autonomic
and subjective indices as the karaoke task. The assessments will quantify
distress elicited by repeated exposure to a relived embarrassing shameful
experience from the distant past, as successfully used by us and others.
Lastly, we will exploratively create an individualized stress response, defined
by the strongest objective stress response during the karaoke-task in the
evening (i.e. the physiology measurement with the largest change between the
karaoke-task and the baseline per participant). With this approach we can
account for the possibility that shame will be expressed in a different
physical manner for different participants.
Other study parameters are autonomic resting state features (electrocardiogram,
galvanic skin responses, blushing response and facial expressions) and features
derived from the nightly electroencephalography (EEG) recording, specifically
regarding REM sleep.
Background summary
The most prevalent and costly mental disorders are Anxiety & Stress Related
Disorders (ASRD) and Insomnia Disorders (ID). The current transdiagnostic
project aims to find answers on why anxious and distressing experiences or
restless nights perpetuate into chronicity of ASRD and ID and to provide means
for better treatment and prevention.
Study objective
We aim to lay the fundament of novel interventions by gaining an in-depth
comprehensive understanding of individual differences in the overnight
adaptation of emotional memory and malleability thereof by noradrenergic
modulation.
Study design
A double-blind placebo controlled intervention study.
Intervention
Participants will be administered a one-time dose of Atomoxetine (40 mg),
Nebivolol (5 mg), Daridorexant (25 mg), Clonidine (50 mcg), and placebo on
separate nights.
Study burden and risks
Participants receive a one-time dose of Atomoxetine (40 mg), Nebivolol (5 mg),
Daridorexant (25 mg), Clonidine (50 mcg), and placebo throughout the course of
the study. Previous studies have shown that a single dose of 40 mg Atomoxetine,
5 mg Nebivolol, 50 mcg Clonidine, and 25 mg of Daridorexant are well tolerated
in healthy adults with very little side effects. Considering the extensive
exclusion criteria, screening procedure and constant monitoring of the
subjects, no serious side effects are expected.
Meibergdreef 47
Amsterdam 1105BA
NL
Meibergdreef 47
Amsterdam 1105BA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a volunteer must meet the
two inclusion criteria of an age of 18 years or older and the capability of
completing online questionnaires and diaries in the Dutch language.
To include the severity of insomnia and anxiety as covariates in our analysis,
we will assess the Insomnia Severity Index (ISI; Morin et al., 2011) and the
Generalized Anxiety Disorder Questionnaire (GAD-7; Williams, 2014) scores of
interested volunteers. These scores will not affect potential inclusion.
Volunteers will undergo formal diagnostic procedures according to the DSM-5
(M.I.N.I.; Sheehan et al., 1998) for descriptive purposes only. Meeting the
criteria of a diagnosis is not an inclusion criterion.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• other relevant treatment for ASRD or ID at the time of study - either
pharmacologically or with cognitive behavioral therapy (CBT)
• diagnosis of mental disorders other than ASRD or ID (co-occurring depression
is allowed).
• use of psychotropic medication
• history of cardiovascular diseases
• heart problems among first-degree relatives
• HR < 60 or HR > 120 (bpm)
• BP < 90/60 or BP > 170/100 (systolic/diastolic mmHg)
• diabetes
• liver or kidney diseases
• hyperactive production of thyroid hormones
• epilepsy
• any medication contra-indicative of the use of Atomexatine, Nebivolol,
Clonidine, or Daridorexant (as described in the Summary of Product
Characteristics)
• pregnancy
• breastfeeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84049.100.23 |