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25th European Congress of Psychiatry / European Psychiatry 41S (2017) S69–S105



Sunovion Pharmaceuticals Inc., Clinical Development, Fort Lee, NJ,


Corresponding author.


Lurasidone is an atypical antipsychotic that demon-

strated efficacy in the treatment of adults with schizophrenia in the

dose range of 37–148mg/day.


The objective of this analysis was to evaluate the

efficacy of lurasidone in adolescent patients with schizophrenia.


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.


A total of 326 patients (mean age, 15.4 years) were ran-

domized and received lurasidone 37mg/day (


= 108), 74mg/day



= 106), or placebo (


= 112). The PANSS total score at week

6 demonstrated a placebo-adjusted, least-squares (LS) mean

improvement of –8.0 (


< 0.001; effect size [ES], 0.51) for the

37mg/day group and –7.7 (


< 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 (


< 0.001; ES = 0.62) and –3.2



< 0.001; ES = 0.60) on the PANSS positive subscale, –1.7 (


= 0.011;

ES = 0.41) and –1.6 (


= 0.022; ES = 0.35) on the PANSS negative sub-

scale, –2.8 (


= 0.012; ES = 0.38) and –2.8 (


= 0.011; ES = 0.37) on

the PANSS general psychopathology subscale, and –1.1 (


= 0.016;

ES = 0.36) and –1.8 (


< 0.001; ES = 0.53) on the PANSS excitability



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.

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.


Efficacy and safety of clozapine in

patients with intellectual disability

P. Ifteni

, A. T


Universitatea Transilvania din Brasov, Facultatea de Medicina,

Brasov, Romania

Corresponding author.


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



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.


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 (


< 0.05).


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.


Childhood trauma and cortisol

response to the Trier Social Stress Test

in symptomatic patients with eating


F. Marciello

1 ,

, V.-M. Buonomenna


, V. Caivano


, G. Cascino



G. D’Agostino


, D. Nunziata


, P. Monteleone



Second University of Naples, Department of Psychiatry, Naples, Italy


University of Salerno, Department of Medicine–Surgery and

Dentistry “Scuola Medica Salernitana”–Section of Neurosciences,

Salerno, Italy

Corresponding author.


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.


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.


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.


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.


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.


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-


Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.