European Psychiatry - Volume 41 - April 2017

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25th European Congress of Psychiatry / European Psychiatry 41S (2017) S69–S105 S91
6 Sunovion Pharmaceuticals Inc., Clinical Development, Fort Lee, NJ,
USA
∗ Corresponding author.
Introduction Lurasidone is an atypical antipsychotic that demon-
strated efficacy in the treatment of adults with schizophrenia in the
dose range of 37–148mg/day.
Objective/Aims The objective of this analysis was to evaluate the
efficacy of lurasidone in adolescent patients with schizophrenia.
Methods Adolescents (13–17 years old) diagnosed with
schizophrenia were randomly assigned to six weeks of double-
blind treatment with lurasidone 37mg/day, 74mg/day or placebo.
Changes from baseline to week 6 in PANSS total and subscale
(positive, negative, general psychopathology, excitability) scores
were evaluated using mixed-model repeated-measures analysis.
Results A total of 326 patients (mean age, 15.4 years) were ran-
domized and received lurasidone 37mg/day (n = 108), 74mg/day
(n = 106), or placebo (n = 112). The PANSS total score at week
6 demonstrated a placebo-adjusted, least-squares (LS) mean
improvement of –8.0 (P < 0.001; effect size [ES], 0.51) for the
37mg/day group and –7.7 (P < 0.001; ES = 0.48) for the 74mg/day
group. Placebo-adjusted LS mean change for lurasidone 37mg/day
and 74mg/day, respectively, was –3.2 (P < 0.001; ES = 0.62) and –3.2
(P < 0.001; ES = 0.60) on the PANSS positive subscale, –1.7 (P = 0.011;
ES = 0.41) and –1.6 (P = 0.022; ES = 0.35) on the PANSS negative sub-
scale, –2.8 (P = 0.012; ES = 0.38) and –2.8 (P = 0.011; ES = 0.37) on
the PANSS general psychopathology subscale, and –1.1 (P = 0.016;
ES = 0.36) and –1.8 (P < 0.001; ES = 0.53) on the PANSS excitability
subscale.
Conclusions In adolescent patients with schizophrenia, lurasi-
done (37mg/day and 74mg/day) demonstrated statistically
significant efficacy and clinically meaningful improvement across
a wide spectrum of symptoms associated with schizophrenia.
Sponsored by Sunovion Pharmaceuticals Inc. ClinicalTrials.gov
identifier: NCT01911429.
Disclosure of interest Dr Correll reports being a consultant and/or
advisor for Alkermes, ForumPharmaceuticals Inc., Gerson Lehrman
Group, IntraCellular Therapies, Janssen/J&J, Lundbeck, Medavante,
Medscape, Otsuka, Pfizer Inc, ProPhase, Sunovion Pharmaceuticals
Inc., Supernus, Takeda, and Teva providing expert testimony for
Bristol-Myers Squibb Company, Janssen, and Otsuka serving on
a Data Safety Monitoring Board for Lundbeck and Pfizer Inc and
receiving grant support from Takeda. Drs Goldman, Cucchiaro,
Deng and Loebel are employees of Sunovion Pharmaceuticals Inc.
O063
Efficacy and safety of clozapine in
patients with intellectual disability
P. Ifteni ∗ eodorescu
Universitatea Transilvania din Brasov, Facultatea de Medicina,
Brasov, Romania
∗ Corresponding author.
Introduction Aggression is common and amajor behavioral prob-
lem in patients with intellectual disability (ID). Antipsychotics are
frequently used for psychosis or challenging behavior. There is lit-
tle literature regarding utilization of clozapine in patients with ID
for aggressive behavior.
Aims and objectives The aims of the study were the evaluation
of efficacy and safety of clozapine in treatment of aggression in
patients with ID.
Methods A longitudinal naturalistic study including a cohort of
225 consecutive patients with intellectual disability admitted to
an acute psychiatric unit between 1 January 2014 and 31 Decem-
ber 2015. Severity of symptoms was assessed at admission with
Modified Overt Aggression Scale (MOAS) and Global Assessment of
Functioning Scale (GAFS). The data included: demographics, main
psychiatric diagnosis, IQ, alcohol/smoking, institutionalization,
antipsychotics and another psychotropics, restraint, readiness to
discharge (RDQ), side-effects and length of stay.
Results Of 225 potentially eligible individuals, 205 (92.7%) were
treated with antypschotics and 110 male (53.56%) with mean age
32.37 (SD = 9.9). Thirty-seven patients (18%), 18 male (48.65%)
were treated with clozapine, mean dose 309.45mg/day (range
100–450mg/day). Clozapine reduced need for restraint and dura-
tion of hospitalization compared with haloperidol (P < 0.05).
Conclusions Clozapine was efficient and safety for treating per-
sistent aggression in patients with intellectual disability. There
were no seizures, myocarditis or agranulocytosis during study.
Larger and randomized trials are needed to fully explore the anti-
aggressive benefit of clozapine.
Disclosure of interest The authors have not supplied their decla-
ration of competing interest.
O064
Childhood trauma and cortisol
response to the Trier Social Stress Test
in symptomatic patients with eating
disorders
F. Marciello ∗, V.-M. Buonomenna , V. Caivano , G. Cascino ,
G. D’Agostino , D. Nunziata , P. Monteleone
1 Second University of Naples, Department of Psychiatry, Naples, Italy
2 University of Salerno, Department of Medicine–Surgery and
Dentistry “Scuola Medica Salernitana”–Section of Neurosciences,
Salerno, Italy
∗ Corresponding author.
Introduction Childhood trauma exposure is associated with the
risk of eating disorders (EDs) in adulthood. The biological basis of
this link may involve a persistent dysregulation of the endogenous
stress response system, in particular the hypothalamic-pituitary-
adrenal (HPA) axis, as a consequence of early life maltreatment.
Objective Adult patients with EDs and history of childhood
trauma may have a dysregulation of the HPA axis that could be
different from EDs patients without childhood trauma exposure.
Aims In order to assess the effects of childhood trauma experi-
ences onHPA-axis activity in EDs, we compared the salivary cortisol
response to the Trier Social Stress Test (TSST) of adult patients with
EDs according to their history of childhood trauma.
Method Twenty-seven EDs patients and 13 healthy women
participated in the study. Salivary cortisol responses during expo-
sure to the TSST was measured. Participants also completed the
childhood trauma questionnaire (CTQ) and eating-related psy-
chopathological rating scales.
Results According to CTQ, 15 individuals with EDs reported child-
hood maltreatment whereas 12 EDs patients and all the healthy
women did not experience childhood maltreatment. Compared
with the control group, non-maltreated EDs patient group exhib-
ited a slightly enhanced cortisol response to TSST, whereas the
group of non-maltreated EDs patients showed a normal cortisol
response. Moreover, EDs patients with childhood maltreatment
exhibited statistically significant blunting of cortisol compared to
non-maltreated ones.
Conclusions The present findings support the evidence that, in
patients with EDs, there is a dysregulation of HPA-axis activity and
that childhood trauma exposure may contribute to this dysregula-
tion.
Disclosure of interest The authors have not supplied their decla-
ration of competing interest.