Fundamental research with the objective to gain more insight in empathic processes within people suffering from psychopathy. Goal is to evaluate if affective empathic can be temporarily altered (in terms of minutes).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Persoonlijkheidsstoornis (psychopathie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Reading the Mind in the Eyes Test (Baron Cohen, 2001);
- Subjective feelings of affective empathy on a Visual Analogue Scale, conform
the Multifaceted Empathy Test (MET; Dziobek et al., 2008);
- Facial electromyographic (EMG) mimicry recording of the zygomaticus major and
the corrugator supercilii muscle activity, following basic emotion inducing
film fragments,
Secondary outcome
The equilibrium of the parasympathetic and sympathetic nerve system will be
measured in terms of heart rate, respiration and skin conductance;
Saliva sampling before and after test procedures, reflecting baseline
functioning of the HPA-axis (cortisol) and HPG-axis (testosterone and
estradiol).
Background summary
Psychopathy is a personality disorder persisting through the lifespan. It
encompasses disturbances in the emotional, interpersonal and behavioral
domains. Psychopathy is operationally defined by the Psychopathy
Checklist-Revised Version (PCL-R; Hare, 1991, 2003). Participants are fully
aware of their diagnosis of psychopathy.
A major component of psychopathy is an empathic disfunctioning. Empathy is a
multidimensional construct that plays an important role in social understanding
and social relationships. According to Soderstrom (2003) psychopathy should be
regarded an empathy disorder. As there is growing evidence that the nonapetide
oxytocin is involved in the processing of cognitive empathy it is hypothesized
that application of oxytocin in male psychopaths will lead to a temporarily
improvement of the psychopath's affective empathy, too.
Study objective
Fundamental research with the objective to gain more insight in empathic
processes within people suffering from psychopathy. Goal is to evaluate if
affective empathic can be temporarily altered (in terms of minutes).
Study design
The study follows a within-subjects, double-blind, counterbalanced
placebo-controlled design in male in-patients with psychopathy. Subjects will
participate in both experimental and placebo condition of which the order is
counterbalanced. Time period between sessions will be at least one week.
Intervention
Procedures on both days are identical and consist of an explanation of the
tasks to be performed, the intranasal administration of either placebo or OT
followed by neuropsychological tests displayed on a computer screen whilst
physiological data are obtained.
Participants will be invited to undergo saliva sampling of indices of HPA-axis
(i.e. cortisol) and HPG-axis (i.e. testosterone and estradiol) on the two trial
days.
Study burden and risks
No burden or risks to be expected.
Heidelberglaan 2
Utrecht 3584CS
NL
Heidelberglaan 2
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
- MALE SEX;;- DIAGNOSIS OF PSYCHOPATHY ACCORDING TO PSYCHOPATHY CHECKLIST - REVISED;;- GOOD PHYSICAL HEALTH;;- AGE BETWEEN 18 AND 60;;- NORMAL OR CORRECTED TO NORMAL VISION; ;- INTELLIGENCE NO LESS THAN BORDERLINE INTELLCTUAL FUNCTIONING.
Exclusion criteria
- OVERSENSITIVITY FOR OXYTOCIN OR CARRIER;;- COLOUR BLINDNESS;;- ILLITERATE OR INSUFFICIENT KNOWLEDGE OF DUTCH LANGUAGE;;- USE OF SSRI'S, MOOD STABILIZERS (E.G. LITHIUM), ANTIPSYCHOTICS OR HORMONAL TREATMENT FOR LIBIDO INHIBITION;;- USE OF ALCOHOL OR RECREATIONAL DRUGS WITHIN LAST 24 HOURS;;- CURRENT PSYCHOTIC DISORDER;;- CURRENT SEVERE DEPRESSIVE DISORDER;;- CURRENT SEVERE ANXIETY DISORDER;;- COMMON COLD WITH SEVERE RUNNING NOSE, CURENTLY OR WITHIN PREVIUOS SEVEN DAYS;;- HISTORY OF NEUROLOGICAL TREATMENT OF BRAIN STRUCTURES OR CURRENT NEUROLOGICAL TREATMENT;;- HISTORY OF ENDOCRINOLOGICAL TREATMENT OR CURRENT ENDOCRINOLOGICAL TREATMENT;;- HISTORY OF SEVERE CLOSED HEAD INJURY WITH LOSS OF CONSCIOUSNESS >15 MINUTES;;- PATIENT'S LEGAL INCAPACITY.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024432-42-NL |
| CCMO | NL35148.041.12 |