European Psychiatry - Volume 33 - March 2016

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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.
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 , W.M. Bahk ∗, Y.S. Woo , K.U. Lee , M.D. Kim ,
W. Kim , J.C. Yang , K.H. Lee , S.Y. Lee
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.
EW443
Characteristics and treatment
patterns of children and adolescents
with attention-deficit/hyperactivity
disorder in real-world practice
settings
A. Joseph , K. Davis , M. Fridman , P. Gustafsson ∗,
J. Quintero , V. Sikirica , T. Banaschewski
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.