Our primary objective is to investigate whether oxytocin administration can affect empathy and emotion recognition in healthy and antisocial adolescents. We expect that oxytocin will enhance empathy and emotion recognition in both healthy and…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference between total scores of cognitive
and affective empathy as well accuracy and reaction time of emotion recognition
between conditions (oxytocin/placebo administration). Additionally, we examine
whether the oxytocin effect is different between traumatized and
non-traumatized antisocial adolescents by comparing the scores between groups
and across conditions.
Secondary outcome
As a secondary parameter, we explore whether total scores on psychopathic
traits and dissociation can moderate the oxytocin effect on empathy and emotion
recognition in healthy and antisocial male adolescents. We also measure
salivary oxytocin levels to examine whether baseline and after administration
peripheral oxytocin is different between antisocial adolescents with and
without severe psychological trauma by comparing the oxytocin levels between
groups and across conditions.
Background summary
Oxytocin administration has been found to enhance empathy and emotion
recognition in adults and autistic patients, but it is still unknown whether
this effect is present in adolescents and especially in antisocial adolescents
with severe deficits in these characteristics (empathy and emotion
recognition). However, the effect of oxytocin can be influenced by severe
psychological trauma, which affects oxytocin synthesis and secretion, and
dissociation or psychopathic traits which are highly prevalent in antisocial
adolescents and related to abnormal oxytocin levels.
Study objective
Our primary objective is to investigate whether oxytocin administration can
affect empathy and emotion recognition in healthy and antisocial adolescents.
We expect that oxytocin will enhance empathy and emotion recognition in both
healthy and antisocial adolescents but this effect will be attenuated in
traumatized antisocial adolescents. As a secondary objective, we explore
whether dissociation and psychopathic traits can moderate the oxytocin effect
and whether baseline and post-administration salivary oxytocin levels differ
between traumatized and non-traumatized antisocial adolescents.
Study design
Study 1 investigates the effect of oxytocin/placebo administration on empathy
and emotion recognition in healthy male adolescents and Study 2 applies the
same design in traumatized and non-traumatized antisocial adolescents.
Intervention
This project includes two randomized, double-blind, placebo-controlled studies
with a single-dose administration of 24IU of oxytocin.
Study burden and risks
Previous reviews and meta-analyses on studies administering oxytocin in humans
have revealed that oxytocin administration has no severe side-effects or
adverse events for the participants and it is safe in doses 18-40 IU in
research settings. The findings of the study are of paramount importance as
they will provide novel evidence on the oxytocin effect on adolescents and
especially antisocial adolescents, possibly leading to the development of
innovative pharmacological interventions.
Montessorilaan 3
Nijmegen 6525 HE
NL
Montessorilaan 3
Nijmegen 6525 HE
NL
Listed location countries
Age
Inclusion criteria
Study 1:
-males
-age 15-18
-no current or previous psychiatric disorder as identified by the MINI-KID
-capable to read and comprehend the Dutch language
-written informed consent signed by themselves and their legal representatives;Study 2:
-Males
-age 15-18
-antisocial behavior and conduct problems as identified by the MINI-KID
-capable to read and comprehend the Dutch language
-written informed consent by themselves and their legal representatives
Exclusion criteria
-IQ lower than 75
-other severe medical problems
-medication for medical problems
-allergic responses to oxytocin
-substance abuse
-nasal surgery
-nasal disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000367-16-NL |
| CCMO | NL56611.000.16 |