Background: Escitalopram is a single isomer SSRI antidepressant
that has been shown in clinical trials to improve depression
symptoms associated with anxiety, panic and social anxiety
disorders. This study was designed to evaluate the efficacy
and tolerability of Escitalopram in the treatment of
depression with or without anxiety symptoms in routine
clinical outpatient clinic (Moizeszowicz, 1998).
Method: Male and female outpatients aged 18 years and
older who met DSM-IV criteria for Mayor Depression Disorder
with baseline scores of 22, or greater, on Montgomery-Åsberg
Depression Scale (MADRS) were assigned to treatment
with Escitalopram (10-20 mg/day) extended 12 weeks,
preceded of 1-week of washout period of another medications.
The primary efficacy variable was the 50% mean change
(recovery), or normal score (remission) (Frank et al.,
1991; Montgomery et al., 1979): ), from baseline in
total MADRS score at week 12. Other efficacy measures
included changes in Hamilton Anxiety Scale (HAM-A),
Clinical Global Impression Scale (Severity and Improvement,
CGI-I, CGI-S) and Adverse Effects Scale (UKU); the subscales
of apparent sadness, inner tension, reduced sleep or
appetite and suicidal though, in the MADRS and psychic
anxiety and somatic anxiety, in the HAM-A
Results: A total of 33 patients received treatment with
Escitalopram. The sample represents patients of the
daily clinic in contrast to classical investigation
The primary efficacy recovery (50% mean change in the
MADRS score), was obtained in 20% of the patients at
week 1 and, 40% at the week 2. Normal score from baseline
in the total MADRS rating (remission), was obtained
in 64% of the patients at week 4, 79% at week 8 and
88% at week 12. Escitalopram was very well tolerated.
Of the 7 patients dropouts, only 2 were attributable
to the antidepressant drug.
Conclusion: Escitalopram is effective, save and well
tolerated in the treatment of patients with MDD with
or without anxiety symptoms
Escitalopram is a single-isomer SSRI antidepressant
that has been show to significantly improve depression
symptoms associated with anxiety, panic and social anxiety
disorder (Davidson et al., 2002).
Escitalopram and R-Citalopram together comprise Citalopram
however; Escitalopram is the therapeutically active
component. Recently, R-Citalopram has been shown to
attenuate the SSRI-activity of Escitalopram. Clinical
trials comparing Escitalopram in treating depression,
shown to be more effective and possibly better tolerated,
than Citalopram (Burke et al., 2002; Gorman et al.,
2002; Montgomery et al., 2001; Owens et al., 2002).
These considerations motivated the present examination
of the safety and efficacy of Escitalopram in the treatment
of Mayor Depression Disorder with or without symptoms
of anxiety in a routine clinical outpatient practice
in Buenos Aires, Argentina.
• One-week wash out period followed by 12 weeks
of treatment with Escitalopram
• Escitalopram dose 10-20 mg/day for 12 week,
Principal Entrance Criteria
• Fulfilled DSM-IV criteria for current episode
of major depression disorder
• Montgomery-Åsberg Rating Scale for Depression
(MADRS) > 22
• Hamilton Anxiety Scale (HAM-A) score > 15.
• Clinical Global Impression of Severity (CGI-S)
and Improvement CGI-I).
• Adverse Effects Scale (UKU)
• Male or female outpatient 18-80 years of page
• Study measurements were made at screening (0)
and 1, 2, 4, 8 and 12 weeks after starting treatment
• MADRS were made at baseline and at weeks 1,
2, 4, 8 and 12. The pre-defined primary measure of antidepressant
efficacy was the change from baseline of MADRS total
score. Additional analyses efficacy included responders
(proportion of patients at least 50% reduction of baseline
MADRS total score/visit) and complete remitters (proportion
of patients with MADRS total score > 12 per visit.
• HAM-A psychic anxiety and somatic anxiety subscales
• Clinical Global Impression Scale (CGI-Severity)
was made at week 0, 1, 2, 4, 8 and 12. CGI- Improvement
was made at week 1, 2, 4, 8 and 12
• Safety was evaluated on the basis of adverse
The data were analyzed in a database (type Excel) with
a microprocessor Amrad 750 Mhz (Statistica v.5, Statsoft
Inc. 1997). The appropriate descriptive statistics were
determined for each variable according to their mensuration
scale and distribution. They were carried out the following
calculations: percentages, accumulated percentages,
confidence intervals for percentages (Odds ratio). When
necessary was carried out the following statistical
tests: Fisher, t-test of Student, Wilcoxon, Kolmogorov-Smirnov,
ANOVA of Kruskall Wallis, Friedman and for repeated
Demographically and clinically are shown in Table 1.
The proportion of responders was very high at week 2
(70%). The MADRS percentages of responders and the confidence
intervals by week, are shown in Table 2.
Furthermore, the proportion of escitalopram-treated
patients in complete remission was also very high and
met 87.9% of the patients in week 12 .The MADRS percentages
of remitters with scores of 12, by week, are shown in
The accumulate percentage of patients of significantly
improvement in MADRS scores, defined as > 50% improvement
in MADRS items single scores, at the first week in apparent
sadness, inner tension, reduced sleep or appetite and
suicidal thoughts of the MADRS, are shown in Table 4.
The CGI-Severity and CGI-Improvement scores by week,
are shown in Table 5.The overall withdrawal rate (approximately
20%) was low: only 3 patients with adverse effects (nausea,
headache and other with insomnia). The others patients
withdrew for individual reasons (migration, work, etc.).
1. Escitalopram significantly improved MDD symptomatology,
on all prospectively defined efficacy measures.
2. Escitalopram 10-20 mg/day is an effective dose in
treating MDD with or without anxiety symptoms.
3. Leading to significant improvement within 1 week
4. Escitalopram was well tolerated.
5. Escitalopram should be considered as first-fine therapy
for MDD with and without anxiety sympoms.
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