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Page Background

24th European Congress of Psychiatry / European Psychiatry 33S (2016) S116–S348

S269

Results

Nicotinic acetylcholine receptor antagonists failed to

show superior efficacy compared to placebo in terms of the

mean change in the Montgomery-Asberg Depression Rating Scale

(MADRS) score [mean difference = –0.12 (95% CI = –0.96 to 0.71);

response rate (risk ratio [RR] = 0.92 (95% CI = 0.83 to 1.02)); and

remission rate [RR] = 1.01 (95% CI= 0.83 to 1.23)].

Conclusion

This meta-analysis failed to confirm preliminary pos-

itive evidence for the efficacy of nicotinic acetylcholine receptor

antagonists in treatment-resistant depression. Further studies

investigating the efficacy of various alternative treatment strate-

gies for treatment-resistant depressionwill help clinicians to better

understand and choose better treatment options for these popula-

tions.

Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.559

EW442

Efficacy and safety of generic

escitalopram (Lexacure) in patients

with major depressive disorder:

A 6-week, multi-center, randomized,

rater-blinded,

escitalopram-comparative,

non-inferiority study

J.H. Jeong

1

, W.M. Bahk

2 ,

, Y.S. Woo

2

, K.U. Lee

3

, M.D. Kim

4

,

W. Kim

5

, J.C. Yang

6

, K.H. Lee

7

, S.Y. Lee

8

1

St. Vincent’s Hospital, psychiatry, Suwon, Republic of Korea

2

Yeouido St. Mary’s Hospital, psychiatry, Seoul, Republic of Korea

3

Uijeongbu St. Mary’s Hospital, psychiatry, Uijeongbu, Republic of

Korea

4

College of Medicine, Jeju National University, psychiatry, Jeju,

Republic of Korea

5

Seoul Paik Hospital, psychiatry, Seoul, Republic of Korea

6

Chonbuk National University Medical School, psychiatry, Jeonju,

Republic of Korea

7

College of Medicine, Dongguk University, psychiatry, Seoul, Republic

of Korea

8

Wonkwang University School of Medicine, psychiatry, Iksan,

Republic of Korea

Corresponding author.

Objectives

The primary aim of this non-inferiority study was to

investigate the clinical effectiveness and safety of generic esci-

talopram (Lexacure) versus branded escitalopram (Lexapro) for

patients with major depressive disorder (MDD).

Methods

The present study included 158 patients who were ran-

domized (1:1) to receive a flexible dose of generic escitalopram

(

n

= 78) or branded escitalopram (

n

= 80) over a 6-week single-

blind treatment period. The clinical benefits in the two groups

were evaluated using the Montgomery–Åsberg Depression Rat-

ing Scale (MADRS), the 17-item Hamilton Depression Rating Scale

(HDRS), the Clinical Global Impressions-Severity Scale (CGI-S), and

the Clinical Global Impressions-Improvement Scale (CGI-I) at base-

line, week 1, week 2, week 4, and week 6. The frequency of adverse

events (AEs) was also assessed to determine safety at each follow-

up visit.

Results

At week 6, 28 patients (57.1%) in the generic escitalo-

pram group and 35 patients (67.3%) in the branded escitalopram

group had responded to treatment (

P

= 0.126), and the remission

rates (MADRS score:

10) were 42.9% (

n

= 21) in generic esci-

talopram group and 53.8% (

n

= 28) in the branded escitalopram

group (

P

= 0.135). The most frequently reported AEs were nausea

(17.9%) in the generic escitalopram group and nausea (20.0%) in

the branded escitalopram group.

Conclusions

The present non-inferiority study demonstrated that

generic escitalopram is a safe and effective initial treatment for

patients with MDD and may also be considered as an additional

therapeutic option for this population.

Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.560

EW443

Characteristics and treatment

patterns of children and adolescents

with attention-deficit/hyperactivity

disorder in real-world practice

settings

A. Joseph

1

, K. Davis

2

, M. Fridman

3

, P. Gustafsson

4 ,

,

J. Quintero

5

, V. Sikirica

6

, T. Banaschewski

7

1

Shire, Global HEOR and Epidemiology, Zug, Switzerland

2

RTI Health Solutions, Health Economics, Research Triangle Park, USA

3

AMF Consulting Inc., Health Economics, Los Angeles, USA

4

Linköping University, Department of Clinical and Experimental

Medicine and Department of Child and Adolescent Psychiatry,

Linköping, Sweden

5

Hosp. University Infanta Leonor, Psychiatry Department, Madrid,

Spain

6

Shire, Global HEOR and Epidemiology, Wayne, USA

7

Central Institute of Mental Health, Department of Child and

Adolescent Psychiatry and Psychotherapy, Mannheim, Germany

Corresponding author.

Objective

To document patient characteristics and treatment

patterns in a real-world population diagnosed with attention-

deficit/hyperactivity disorder (ADHD).

Methods

This was a retrospective chart review of chil-

dren/adolescents (6–17 years) diagnosed with ADHD in the UK,

Germany and Netherlands who initiated stimulant monother-

apy (SM), non-stimulant (atomoxetine) monotherapy (NSM)

or polypharmacy (SM/NSM

±

SM/NSM or other psychotropics)

on/after 1-1-2012. To facilitate descriptive comparisons, cohort

quotas were imposed:

50% SM;

25% NSM;

25% polypharmacy.

Index date was first SM, NSM or polypharmacy treatment on/after

1-1-2012. Patients were required to have

6 months’ pre-index

(baseline) history and

12months’ post-index follow-up. Analyses

were descriptive.

Results

In total, 497 patients were included (mean [SD] age: 10.8

[2.9] years; 77% male); 65% (SM), 63% (NSM) and 83% (polyphar-

macy) had at least marked baseline ADHD severity based on

Clinical Global Impressions scale (

P

< 0.05 SM/NSM vs polyphar-

macy). Ninety percent (SM), 75% (NSM) and 73% (polypharmacy)

were pharmacotherapy naïve at index (all

P

< 0.10); 61% (SM),

65% (NSM) and 72% (polypharmacy) received previous behavioural

therapy. In SM patients, methylphenidate was predominant (most

frequent brands: Concerta

®

[29%], Medikinet

®

[28%]); in polyphar-

macy patients, methylphenidate plus atomoxetine (22%) or other

psychotropic (19%) was most common. Index therapy switch was

common, particularly in polypharmacy patients (25%) (

P

< 0.05 vs

SM [14%] and NSM [13%]). Switches were precipitated by poor

response in 75% of cases overall.

Conclusions

Polypharmacy patients generally presented a more

complicated history (including higher ADHD severity) and treat-

ment pathway versus monotherapy patients. Index therapy

switches were commonplace and more frequent in polypharmacy

patients, often due to poor response.

Disclosure of interest

The authors have not supplied their decla-

ration of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.561