European Psychiatry - Volume 33 - March 2016

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24th European Congress of Psychiatry / European Psychiatry 33S (2016) S116–S348 S285
were likely to have memory and executive dysfunctions. It has
been shown that psychosocial risk factors had played an impor-
tant role in developing psychosis. However, these factors also may
negatively affect cognitive functions that may make the patient
predispose to develop psychosis in FEP patients.
Disclosure of interest The authors have not supplied their decla-
ration of competing interest.
EW487
Pharmacokinetics, safety, and
tolerability of four 28-day cycle
intramuscular injections for
risperidone-ISM 75 mg in patients
with schizophrenia: A phase-2
randomized study (PRISMA-2)
L. Anta ∗, J. Llaudó , I. Ayani , B. Gorostidi , M. Monreal ,
J. Martínez-González , L. Ochoa , I. Gutierro
Rovi S.A., Medical Dpt, Madrid, Spain
∗ Corresponding author.
Introduction Risperidone-ISM is a new long acting intramuscu-
lar formulation of risperidone, for monthly administration without
oral supplementation.
Objective To characterize the pharmacokinetic of risperidone
overmultiple intramuscular injections in patients with schizophre-
nia.
Method A multicenter, open label, two-arm, parallel design clin-
ical trial was performed. Each patient received 4 intramuscular
injections of 75 mg of risperidone-ISM in either, gluteal or deltoid
muscle at 28-day intervals.
Results A total of 70 patients were randomized, 67 received at
least one dose of study medication. Preliminary data show that
mean Cmax of the active moiety was achieved 24-48 hours (Tmax)
after each administration and ranged over four consecutive doses
from 39.6-53.2 ng/mL and 54.1-61 ng/mL, when given in gluteal
or deltoid, respectively. All subjects achieved therapeutic levels
(> 7.5 ng/mL for the active moiety) between 2-8 hours after drug
administration. The mean concentrations were maintained above
therapeutic levels throughout the 4-week dosing period. No signif-
icance changes across the study were observed, either on Positive
and Negative Syndrome Scale or Extrapyramidal Symptoms Scale.
Overall, 63 subjects (94%) experienced at least 1 Treatment Emer-
gent Adverse Event (TEAE) during the study. One serious TEAE
(dystonia) was related to study treatment. One death not related
to study medication was informed. The most frequently reported
TEAEs were hyperprolactinaemia (57.7%) and injection site pain
(32.8%).
Conclusions Risperidone-ISM achieved therapeutic levels from
the first hours after drug administration and provided a sus-
tained release throughout the 4-weeks dosing period over multiple
intramuscular injections independently of the injection site.
Risperidone-ISM was found to be safe and well tolerated.
Disclosure of interest The authors have not supplied their decla-
ration of competing interest.
EW488
The association between childhood
trauma and empathy in patients with
stable schizophrenia
A. Arous ∗, R. Trabelsi , J. Mrizak , A. Aissa , H. Ben Ammar ,
Z. El Hechmi
Razi hospital, department psychiatry F, Tunis, Tunisia
∗ Corresponding author.
Introduction Empathy, which refers to the ability to understand
and share the thoughts and feelings of others, has emerged as an
important topic in the field of social neuroscience. It is one of the
most understudied dimensions of social cognition in schizophrenia
(SCZ).
Objectives To investigate the relationship between cognitive and
affective empathy and CT in SCZ.
Methods Fifty-eight outpatients with stable SCZ completed the
Childhood Trauma Questionnaire retrospectively assessing five
types of childhood trauma (emotional, physical and sexual abuse,
and emotional andphysical neglect). They also completed theQues-
tionnaire of Cognitive and Affective Empathy (QCAE) comprising
five subscales intended to assess cognitive and affective compo-
nents of empathy.
Results Patients with a history of sexual abuse better emotion
contagion scores (P = 0.048) which means that develop more easily
self-oriented emotional state matching the affective states of oth-
ers. Patients with a history of emotional neglect or/and in denial
of CT had higher scores in perspective taking score (P = 0.017). Per-
spective taking assesses the extent to which respondents can take
another’s perspective or see things from another’s point-of-view.
Conclusions Investigating psychosocial mechanisms, specifically
the role of CT, underlying the development of empathic capacities
is important since empathy can represent a treatment-target.
Disclosure of interest The authors have not supplied their decla-
ration of competing interest.
EW489
How do social cognition dimensions
relate to DSM-5 dimensions of
psychosis?
A. Arous∗, J. Mrizak , R. Trabelsi , A. Aissa , H. Ben Ammar ,
Z. El Hechmi
Razi hospital, department psychiatry F, Tunis, Tunisia
∗ Corresponding author.
Introduction Existing research shows that individuals with
schizophrenia (SCZ) show substantial deficits in social cognitive
domains, including facial emotion recognition (FER), empathy, and
Theory of Mind (ToM). Their exact relationship with the differ-
ent dimensions included in the “Clinician- Rated Dimensions of
Psychosis Symptom Severity” of the 5th edition of the Diagnos-
tic and Statistical Manual of Mental Disorders (DSM-5) remains
unexplored.
Objectives To investigate the relationship between different
social cognition dimensions and the dimensions of psychosis
included in the DSM-5.
Methods Fifty-eight outpatients with stable SCZ completed the
Intention-Inferencing Task (IIT), a non-verbal ToM task and the
Questionnaire of Cognitive and Affective Empathy (QCAE). They
also completed a newly developed and validated FER task con-
structed from photographs of the face of a famous Tunisian actress
and evaluating the ability to correctly identify Ekman’s six basic
facial emotions. The clinician-rated dimensions of psychosis symp-
tom severity was used to evaluate 8 dimensions of psychosis.
Results The patients presenting higher cognitive empathy capac-
ities had less present abnormal psychomotor behaviour scores
(P = 0.05). Higher levels of affective empathy were correlated to
lower present delusions score (P = 0.037). Better scores in the IIT
were correlated to less present negative scores (P = 0.013) and less
impaired cognition scores (P = 0.009). FER task score didn’t corre-
lated with any clinical dimension.
Conclusions Our results suggest the existence of specific rela-
tionships between social cognition dimensions and psychosis
dimensions. Further studies are needed to confirm these relation-
ships.