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24th European Congress of Psychiatry / European Psychiatry 33S (2016) S72–S115

S101

Fig. 1

Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.

Acknowledgments

L. Galindo is funded by the fellowship Río

Hortega Spanish government ISCIII (CM14/00111).

http://dx.doi.org/10.1016/j.eurpsy.2016.01.074

FC71

An interventional, multi-center,

randomized, double-blind,

placebo-controlled, active reference,

flexible dose study of brexpiprazole in

adults with acute schizophrenia

S.R. Marder

1

, M. Hakala

2 ,

, M. Gislum

3

, A. Skuban

4

, E. Weiller

5

,

C. Weiss

6

1

Desert Pacific Mental Illness Research, Education and Clinical

Center, Semel Institute for Neuroscience at UCLA, Department of

Psychiatry and Biobehavioral Sciences, Los Angeles, USA

2

Lundbeck A/S, ICR Psychiatry, DK, Valby, Denmark

3

H. Lundbeck A/S, Department of Biostatistics, Valby, Denmark

4

Otsuka Pharmaceutical Commercialization and Development Inc.,

Global Clinical Development, Princeton, USA

5

H. Lundbeck A/S, Medical Affairs, Valby, Denmark

6

Otsuka Pharmaceutical Commercialization and Development Inc.,

Global Medical Affairs, Princeton, USA

Corresponding author.

Introduction

Brexpiprazole is a serotonin-dopamine activity

modulator that is a partial agonist at 5-HT

1A

and dopamine D

2

receptors at similar potency, and an antagonist at 5-HT

2A

and nor-

adrenaline alpha

1B/2C

receptors.

Objectives

Evaluating the efficacy, safety, and tolerability of flex-

ible doses of brexpiprazole compared with placebo in patients with

acute schizophrenia.

Aim

Primary endpoint was change from baseline to week 6 in

PANSS total score and key secondary endpoint was change from

baseline to week 6 in CGI-S score.

Methods

Phase 3, multi-center, randomized, double-blind,

placebo-controlled, active reference, trial (NCT01810380). Hospi-

talized patients were randomized to brexpiprazole (2 to 4mg/day),

placebo, or quetiapine extended release (400 to 800mg/day) for

6 weeks. Quetiapine was included as an active reference. Changes

from baseline were analyzed using an MMRM approach.

Results

Mean change in PANSS total score was

20.0 and

15.9

in the brexpiprazole (

n

= 150) and placebo (

n

= 159) groups, respec-

tively (

P

= 0.056). Sensitivity analyses suggested treatment effect

(e.g., ANCOVA, LOCF:

P

= 0.025; ANCOVA, OC:

P

= 0.026). Mean

change in PANSS total score (

24.0) with quetiapine (

n

= 150) was

significantly greater than thatwithplacebo (

P

< 0.001), demonstrat-

ing sensitivity of the assay. Brexpiprazole separated from placebo

on the mean change in CGI-S score (

1.2 vs.

0.9,

P

= 0.014). The

proportion of patients reporting TEAEs were similar between the

brexpiprazole and placebo treatment groups (54% versus 54.7%).

Conclusion

Treatment with brexpiprazole showed a clinically

meaningful improvement in patients with acute schizophrenia.

While the difference between brexpiprazole and placebo only

approached statistical significance, sensitivity analyses and sec-

ondary endpoints supported a treatment effect of brexpiprazole.

Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.075

FC72

Are self-stigma and coping strategies

interrelated in outpatients with

schizophrenia spectrum disorders

using the psychiatric medication?

Cross-sectional study

M. Holubova

1 , 2 ,

, J. Prasko

1

, R. Hruby

3

, K. Latalova

1

,

M. Slepecky

4

, M. Marackova

1

, D. Kamaradova

1

, T. Gubova

2

1

Faculty of Medicine and Dentistry, Palacky University Olomouc,

University Hospital Olomouc, Department of Psychiatry, Olomouc,

Czech Republic

2

Regional Hospital Liberec, Department of Psychiatry, Liberec, Czech

Republic

3

Psychiatric Outpatient Department, Psychiatric Outpatient

Department, Martin, Slovakia

4

Faculty of Social Science and Health Care, Constantine the

Philosopher University in Nitra, Department of Psychology Sciences,

Nitra, Slovakia

Corresponding author.

Introduction

Self-stigma is the maladaptive psychosocial phe-

nomenon that can affect the patient’s self-image, may lead to

dysphoria, social isolation, reduced adherence and quality of life.

Maladaptive coping strategies may adversely disturb the overall

functioning of psychiatric patients.

Objectives

Thinking about coping strategies and self-stigma in

practice may play a significant role in understanding patients with

schizophrenia spectrum disorders, especially for mental health

professionals. Focus on coping strategies could be a useful con-

cept in supportive and educational therapy to help patients in using

more adaptive coping strategies and decrease their self-stigma.

Aims

The aimof this studywas to determine the relationbetween

coping strategies and the self-stigma among outpatients with

schizophrenia and related disorders.

Methods

Stress Coping Style Questionnaire (SVF-78), Internal-

ized Stigma of Mental Illness (ISMI) and severity of the disorder

(measured by Clinical Global Impression objective and subjective

form) were assessed.

Results

One hundred and four patients suffering from

schizophrenia (

n

= 67), schizoaffective disorder (

n

= 30), poly-

morphic psychotic disorder (

n

= 3), schizotypal disorder (

n

= 2)

and delusional disorder (

n

= 2) were included in the study. The

results showed that there was a high positive correlation between

negative coping and self-stigma, and the negative correlation

between positive strategies and the overall score of self-stigma.

Stepwise regression analysis showed that negative coping (espe-

cially resignation), subjective severity SubjCGI and positive coping