Article

A Randomized, Placebo-Controlled Trial of Citalopram

for the Treatment of Major Depression
in Children and Adolescents
Karen Dineen Wagner, M.D.,
Ph.D.
Adelaide S. Robb, M.D.
Robert L. Findling, M.D.
Jianqing Jin, Ph.D.
Marcelo M. Gutierrez, Ph.D.
William E. Heydorn, Ph.D.

Objective: Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective
and safe for the treatment of depressive
symptoms in children and adolescents.
The current study investigated the efficacy
and safety of citalopram compared with
placebo in the treatment of pediatric patients with major depression.
Method: An 8-week, randomized, doubleblind, placebo-controlled study compared
the safety and efficacy of citalopram with
placebo in the treatment of children (ages
711) and adolescents (ages 1217) with
major depressive disorder. Diagnosis was
established with the Schedule for Affective
Disorders and Schizophrenia for SchoolAge ChildrenPresent and Lifetime Version. Patients (N=174) were treated initially
with placebo or 20 mg/day of citalopram,
with an option to increase the dose to 40
mg/day at week 4 if clinically indicated.
The primary outcome measure was score
on the Childrens Depression Rating Scale
Revised; the response criterion was defined
as a score of 28.

Results: The overall mean citalopram

dose was approximately 24 mg/day. Mean
Childrens Depression Rating ScaleRevised scores decreased significantly more
from baseline in the citalopram treatment
group than in the placebo treatment group,
beginning at week 1 and continuing at every observation point to the end of the
study (effect size=2.9). The difference in response rate at week 8 between placebo
(24%) and citalopram (36%) also was statistically significant. Citalopram treatment
was well tolerated. Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups
(5.9% versus 5.6%, respectively). Rhinitis,
nausea, and abdominal pain were the
only adverse events to occur with a frequency exceeding 10% in either treatment
group.
Conclusions: In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to
a significantly greater extent than placebo
treatment and was well tolerated.
(Am J Psychiatry 2004; 161:10791083)

p to 5% of children and 8% of adolescents meet

diagnostic criteria for depression, with the incidence of
depression increasing markedly after puberty (14). The
mean duration of pediatric depressive episodes is 9 months,
and there is substantial risk for relapse (4, 5). Like depression in adults, pediatric depression is associated with significant social and functional impairment. School performance, peer relationships, and family functioning all are
affected negatively in children and adolescents with depression (6), and risk of suicide is increased (7). Furthermore, depression in children and adolescents frequently
continues into adulthood, resulting in considerable morbidity and mortality (8).
Although childhood depression is increasingly being
recognized, few randomized, placebo-controlled trials of
antidepressant pharmacotherapy have been reported in
this population, and those that have appeared in the literature have had mixed results. For example, trials with tricyclic antidepressants have not demonstrated superiority
over placebo (9). However, several recently published
Am J Psychiatry 161:6, June 2004

studies have suggested that selective serotonin reuptake

inhibitors (SSRIs) may be effective and well tolerated in
children and adolescents. In double-blind, placebo-controlled trials, fluoxetine (10, 11) and sertraline (12) have
shown efficacy in the treatment of children and adolescents with major depression, as has paroxetine for the
treatment of depressed adolescents (13). The use of SSRIs
in children and adolescents has increased dramatically as
a result of these trials, case reports, and open-label studies. Indeed, approximately 70% of family physicians and
pediatricians in one mail survey reported prescribing SSRIs to children and adolescents with psychiatric disorders,
including depression (14).
Citalopram, an SSRI shown to be effective in the treatment of depression in the adult population (1517), appears well suited for use in children and adolescents because it has a favorable side effect profile, a low potential
for drug-drug interactions, and is relatively safe in overdose (18, 19), which is of concern in this population (7).
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TABLE 1. Demographic and Clinical Characteristics of Children and Adolescents With Major Depressive Disorder
Randomly Assigned to 8 Weeks of Double-Blind Treatment With Citalopram or Placebo
Subjects Given
Placebo (N=85)
N
%

Characteristic

Male gender
Caucasian race
Disease course
Recurrent
Single episode

Weight (lb)
Age (years)
Duration of major depressive
disorder (years)
Duration of episode (months)
Age at onset (years)

Subjects Given
Citalopram (N=89)
N
%

39
62

45.9
72.9

42
72

47.2
80.9

15
70

17.6
82.4

19
70

21.3
78.7

Mean

SD

Mean

SD

125.6
12.1

57.2
2.8

123.7
12.1

51.0
3.1

2.2
18.6
9.8

1.9
16.4
3.0

2.3
20.8
9.8

2.0
21.4
3.3

Additionally, open-label trials and case reports suggest

that citalopram is effective in younger patients (20, 21).
The objective of the current randomized, double-blind,
placebo-controlled, flexible-dose study was to compare
the efficacy and safety of citalopram with placebo in the
treatment of children and adolescents with major depressive disorder.

Method
Study Population
This study was conducted at 21 hospital, academic, and research centers in the United States. Children (ages 711) and adolescents (ages 1217) who met DSM-IV criteria for major depressive disorder and whose current episode of major depressive
disorder was at least 4 weeks in duration at baseline were eligible
for participation. The Schedule for Affective Disorders and
Schizophrenia for School-Age ChildrenPresent and Lifetime
Version (K-SADS-PL) (22), a semistructured diagnostic interview,
was used to establish that patients met DSM-IV criteria for major
depressive disorder and to rule out other psychiatric diagnoses. A
score of at least 40 on the Childrens Depression Rating ScaleRevised (23, 24) was required at the screening and baseline visits.
Additional inclusion criteria were a normal physical examination, laboratory tests, and ECG results. Female patients of childbearing potential were required to have negative serum human
chorionic gonadotropin levels at screening and be willing to practice a reliable method of birth control. Patients were required to
provide assent prior to participation, and the parent or legal guardian had to provide written consent. A parent or caregiver was required to accompany the patient at each visit. The study protocol
was approved by institutional review boards at each study center.
Patients were excluded from the study for any of the following
reasons: 1) primary psychiatric diagnoses other than major depressive disorder; 2) a DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD), posttraumatic stress disorder, bipolar disorder, pervasive development disorder, mental retardation,
conduct disorder, or oppositional defiant disorder; 3) any psychotic features; 4) any personality disorder that would interfere
with study participation; 5) a history of alcohol or substance abuse
within the past year; or 6) anorexia or bulimia within the past year.
Initiation of psychotherapy or behavioral therapy 3 months prior

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to the screening visit or during the study was not allowed. Patients
who were considered a suicide risk, who had made an active suicide attempt within the past year, or had been hospitalized because of an attempt also were excluded.
Patients who had been treated with any antidepressant or anxiolytic medication within 2 weeks of baseline (4 weeks for fluoxetine), had been treated with a neuroleptic or stimulant within 6
months prior to screening, or received an investigational drug 30
days prior to study entry were excluded. Concomitant treatment
with certain prescription or over-the-counter medications (e.g.,
antipsychotics, anticonvulsants, sedatives, hypnotics, and cardiovascular agents, among others) also was prohibited per protocol.

Study Design
Following an initial screening visit and a 1-week, single-blind
placebo lead-in period, patients returned for a baseline visit to
determine whether they remained eligible to participate. Eligible
patients were then randomly assigned in double-blind fashion to
8 weeks of citalopram or placebo treatment. Citalopram was initiated at 20 mg/day, with the potential to increase the dose to 40
mg/day anytime after week 4 if deemed clinically necessary. Subsequent to week 4, the dose could be decreased to 20 mg/day for
tolerability reasons. Evaluations were scheduled after 1, 2, 4, 6,
and 8 weeks of double-blind treatment.
The primary outcome measure in this study was the change
from baseline in score on the Childrens Depression Rating
ScaleRevised at week 8 or upon termination. The Childrens Depression Rating ScaleRevised was administered at each study
visit. Response was defined as a score of 28 (indicating minimal
residual symptoms). Secondary measures included Clinical Global Impression (CGI) improvement and severity ratings (25). At
the final visit (week 8), a physical examination and laboratory
tests were performed, and ECG results were obtained. Adverse
events were spontaneously reported by patients or observed by
investigators.

Statistical Analyses
Treatment differences in the primary efficacy outcome, baseline-to-endpoint change in score on the Childrens Depression
Rating ScaleRevised, in patients treated with citalopram versus
patients treated with placebo were assessed using an analysis of
covariance model, with treatment, study center, and age group as
factors and the baseline score as covariate. A Cochran-MantelHaenszel test controlling for center and age group was applied for
between-treatment comparison with respect to the response rate.
These analyses were carried out using the last observation carried
forward approach at week 8.

Results
A total of 178 patients (93 in the citalopram group and
85 in the placebo group) were randomly assigned to double-blind treatment. Four patients (three children and one
adolescent), all randomly assigned to the citalopram
group, were lost to follow-up and did not receive study
medication. These patients were not included in the intent-to-treat analyses. Thus, the intent-to-treat population consisted of 89 patients (45 children and 44 adolescents) assigned to citalopram and 85 patients (38 children
and 47 adolescents) assigned to placebo. Of these, 18 patients from each group discontinued double-blind treatment prematurely. Demographic and clinical characteristics of the patient population at baseline are summarized
in Table 1. There were no significant differences in age,
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WAGNER, ROBB, FINDLING, ET AL.

Mean Change From Baseline in Score on

Children's Depression Rating ScaleRevised

FIGURE 1. Baseline-to-Endpoint Changes in Score on the

Childrens Depression Rating ScaleRevised in Children
and Adolescents With Major Depressive Disorder Randomly Assigned to 8 Weeks of Double-Blind Treatment
With Citalopram or Placebo
0

Patients Experiencing Event

Placebo Group
(N=85)

Subjects receiving placebo (N=85)

Adverse Event
Rhinitis
Nausea
Abdominal pain
Influenza-like symptoms
Fatigue
Diarrhea
Back pain

Subjects receiving citalopram (N=89)

5
*

10

15

*
20

**

25

*p<0.05.

TABLE 2. Treatment-Emergent Adverse Eventsa in Children

and Adolescents With Major Depressive Disorder Randomly Assigned to 8 Weeks of Double-Blind Treatment
With Citalopram or Placebo

4
Treatment Week

**p<0.01.

gender, race, or weight between the placebo and citalopram groups. The mean age was 12.1 years in both treatment groups, and there were no differences between
groups in the mean ages of children and adolescents. Additionally, responses to the K-SADS-PL (administered at
the screening visit) indicated there were no clinically
meaningful differences between the citalopram and placebo treatment groups in depression history. Ongoing secondary psychiatric disorders other than depression were
reported in 23 patients, the most common diagnosis being
dysthymia (citalopram group: 5.6%, placebo group: 1.2%)
and enuresis (citalopram group: 4.5%, placebo group:
3.5%). A previous diagnosis of ADHD had been made in
four citalopram-treated patients (4.5%) and one placebotreated patient (1.2%); there were no reports of ongoing
ADHD. Approximately 80% of the patients who participated in the study were experiencing a single episode of
depression with a mean duration of 2 years. The mean duration of the current depressive episode was about 20
months. The age at onset was approximately 7 years for
children and 12 years for the adolescent group. Twenty
percent of the patients in the citalopram group and 18% of
patients in the placebo group received previous antidepressant treatment, and approximately 15% of the patients in the citalopram group and 16% of the patients in
the placebo group had a history of nonresponse to antidepressant treatment. Mean Childrens Depression Rating
ScaleRevised scores at baseline were 58.8 (SD=10.9) and
57.8 (SD=11.1) in the citalopram and placebo groups, respectively, indicative of moderately severe illness.
As noted in the Method section, investigators had the
option to increase the dose of study medication to 40 mg/
day citalopram or placebo equivalent any time after the
Am J Psychiatry 161:6, June 2004

N
5
3
6
0
1
1
3

Citalopram Group
(N=89)

%
5.9
3.5
7.1
0.0
1.2
1.2
3.5

N
12
12
10
6
5
5
5

%
13.5
13.5
11.2
6.7
5.6
5.6
5.6

Adverse events listed are those that occurred with a frequency >5%
in the citalopram group and that had an incidence in patients
treated with citalopram that exceeded the incidence in patients
treated with placebo.

week 4 visit. By the end of the study, medication dose had

been increased in 53 placebo-treated patients (62.4%) and
in 48 citalopram-treated patients (53.9%). In the citalopram group, the mean daily dose over the 8-week treatment period was 23.3 mg/day (SD=5.0) for the children
and 24.4 mg/day (SD=5.0) for the adolescents.
Citalopram treatment showed statistically significant
improvement compared with placebo on the Childrens
Depression Rating ScaleRevised as early as week 1 (F=
6.58, df=1, 150, p<0.05), which persisted throughout the
study (Figure 1). At week 8, the effect size on the primary
outcome measure, Childrens Depression Rating Scale
Revised (last observation carried forward), was 2.9. Additionally, at endpoint more citalopram-treated patients
(36%) met the prospectively defined criterion for response
than did placebo-treated patients (24%), a difference that
was statistically significant (2=4.178, df=1, p<0.05). The
proportion of patients with a CGI improvement rating 2
at week 8 was 47% for the citalopram group and 45% for
the placebo group (last observation carried forward values). For the CGI severity rating, baseline values were 4.4
for the citalopram group and 4.3 for the placebo group,
and endpoint values (last observation carried forward)
were 3.1 for the citalopram group and 3.3 for the placebo
group.
Citalopram treatment was well tolerated. All treatmentemergent adverse events that occurred with a frequency
>5% in the citalopram group, and with an incidence in citalopram-treated patients that exceeded that in placebotreated patients, are listed in Table 2. Of these, nausea,
rhinitis, and abdominal pain were the only adverse events
occurring in 10% of citalopram-treated patients. There
were no reports of mania. The rate of discontinuation due
to adverse events was comparable in the placebo and citalopram groups (5.9% versus 5.6%, respectively). The only
adverse events that led to the discontinuation of more
than one patient were aggravated depression (two placebo, no citalopram) and agitation (no placebo, two citalopram). No clinically significant ECG results, laboratory
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values, or weight changes were found. No serious adverse

events were observed in any patient treated with citalopram in this study.

Discussion
This randomized, placebo-controlled, double-blind
trial provides evidence that citalopram produces a statistically and clinically significant reduction in depressive
symptoms in children and adolescents. Specifically, citalopram was superior to placebo on the primary efficacy
measure, score on the Childrens Depression Rating
ScaleRevised, as early as week 1 with efficacy continuing
throughout the trial. Reported adverse events were mild,
and the rate of discontinuation due to adverse events was
similar in the placebo and citalopram groups.
The results of this trial are in agreement with previous
open-label trials (20) and case reports (21), which suggest
that citalopram is efficacious and safe in children and adolescents with depression. In the current trial, citalopramtreated patients demonstrated significant improvement in
depressive symptoms compared with placebo at week 1,
an earlier time point than has been reported in other published trials of SSRIs in children and adolescents (1012),
although one placebo-controlled trial demonstrated significance for fluoxetine at week 1 (11). This is a potentially
important observation, since therapeutic treatment options in these young patients remain limited, and early
amelioration of symptoms may serve to enhance adherence to an adequate course of therapy.
In our study, the prospectively defined criterion of response was an endpoint score of 28 on the Childrens Depression Rating ScaleRevised. In the Emslie et al. study
of fluoxetine (11), a Childrens Depression Rating Scale
Revised endpoint total score 28 was defined as remission.
It is noteworthy, therefore, that the rates of response for
citalopram (36%) were similar to the remission rates for
fluoxetine (41%).
It is tempting to speculate that similar clinical results
would be achieved in children and adolescents treated
with the recently developed single isomer compound escitalopram, since the serotonin reuptake activity of citalopram is attributable to its S-isomer (26). This hypothesis is
being tested in a multicenter, randomized, double-blind
study of escitalopram in pediatric patients that is currently under way.
The mean citalopram dose for children and adolescents
over the 8-week trial was approximately 25 mg/day, which
is similar to the minimum dose shown to be effective in
adults (27). There were no serious adverse events observed
in the citalopram group. In fact, the overall adverse event
profile was similar to that reported in adult trials, with no
new or unexpected adverse events reported. Notably absent in this population of children and adolescents were
dizziness and somnolence, two events frequently reported
by adult patients (18). In this study, psychiatric adverse

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events were reported infrequently by patients randomly

assigned to citalopram. For example, adverse events associated with behavioral activation (such as insomnia or agitation) were not prevalent in this trial.
The consistent and significant reduction in Childrens
Depression Rating ScaleRevised score in citalopramtreated patients compared with placebo-treated patients
at weeks 1, 2, and 4 suggests that citalopram, 20 mg/day, is
an effective dose in this population, since the citalopram
dose was fixed throughout the first 4 weeks of the trial.
Of interest, early and sustained improvements in Childrens Depression Rating ScaleRevised scores were observed with citalopram treatment in this study despite a
relatively high rate of placebo response (which is common
in pediatric trials with antidepressants). The study was not
powered sufficiently to detect treatment differences by age
group. Other limitations include the low number of patients with comorbid conditions and concomitant medication use, both of which are common in younger patients. It
is not known whether the presence of comorbid psychiatric disorders such as ADHD would have affected the observed outcomes of this trial; however, the exclusion criteria employed produced a study population comparable to
those of Emslie et al. (11) and Wagner et al. (12).
In conclusion, citalopram treatment significantly improved depressive symptoms compared with placebo
within 1 week in this population of children and adolescents. No serious adverse events were reported, and the
rate of discontinuation due to adverse events among
citalopram-treated patients was comparable to that of
placebo. These findings further support the use of citalopram in children and adolescents suffering from major
depression.
Presented in part at the 155th annual meeting of the American Psychiatric Association, Philadelphia, May 1823, 2002. Received Dec. 4,
2002; revisions received Aug. 20 and Oct. 28, 2003; accepted Dec. 4,
2003. From the Department of Psychiatry and Behavioral Sciences,
University of Texas Medical Branch, Galveston; Childrens National
Medical Center, Washington, D.C.; University Hospitals of Cleveland;
Forest Laboratories, Inc., New York; and Lexicon Pharmaceuticals,
Princeton, N.J. Address reprint requests to Dr. Wagner, Department of
Psychiatry and Behavioral Sciences, University of Texas Medical
Branch, 301 University Blvd., Galveston, TX 77755-0188; Kwagner@
utmb.edu (e-mail).
Supported by funding from Forest Pharmaceuticals.

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