JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY

Volume 13, Number 3, 2003

© Mary Ann Liebert, Inc.
Pp. 329–335

An Open Trial of Fluoxetine for

Adolescents with Bulimia Nervosa

Lisa A. Kotler, M.D.,1 Michael J. Devlin, M.D.,2 Mark Davies, M.P.H.,1 and
B. Timothy Walsh, M.D.1,2

ABSTRACT

Objective: This open clinical trial examined the feasibility, tolerability, and efficacy of treat-
ing adolescents who suffer from bulimia nervosa with fluoxetine.
Methods: Ten adolescents, ages 12–18 years received 8 weeks of fluoxetine 60 mg/day with
supportive psychotherapy. Primary outcome measures included frequencies of binge eating
and purging and ratings on the Clinical Global Impressions–Improvement scale (CGI-I). Sec-
ondary outcome measures included self-report measures of eating disorder, depression, and
anxiety symptoms. Safety and tolerability of this dose of fluoxetine were also assessed.
Results: Average weekly binges decreased significantly from 4.1 ± 3.8 to 0 (p < 0.01). Aver-
age weekly purges decreased significantly from 6.4 ± 5.2 to 0.4 ± 0.9 (p < 0.005). All patients
improved on the CGI-I scale, with 20% rated as much improved, 50% improved, and 30%
slightly improved. All subjects tolerated the 60-mg dose of fluoxetine, and there were no
dropouts due to adverse effects from the medication.
Discussion: Fluoxetine is generally well tolerated and may be an effective treatment option
for adolescents with bulimia nervosa.

INTRODUCTION cases of BN have their onset during or after pu-

berty (Lask and Bryant-Waugh 1997), although

B eating disor-
ULIMIA NERVOSA (BN) IS A DISABLING
der that commonly arises in adolescence and
has serious medical and psychiatric sequelae.
The prevalence of the Diagnostic and Statistical
Manual of Mental Disorders, fourth edition (DSM-
IV; American Psychiatric Association 1994)
strictly defined disorder among adolescent and
young adult females has been estimated at 1–3%
(Hsu 1996; Stein 1991; Whitaker 1992). Binge eat-
ing and purging behaviors are more common,
with 10–50% of teenage females reporting occa-
sional self-induced vomiting or binge eating epi-
sodes (Fisher et al. 1995). It appears that most
there have been reports of pre-menarchal BN in
the literature (Kent et al. 1992; Stein et al. 1998).
Adolescents and adults with BN often present
with symptoms of other disorders, including de-
pressive and anxiety disorders. It is not known
whether these symptoms are primary or sec-
ondary to the eating disorder (Fisher et al. 1995).
In the past 20 years, there have been sig-
nificant advances in our understanding of treat-
ments for eating disorders, specifically regarding
pharmacological treatments. The short-term effi-
cacy of antidepressant medications in BN has
been well documented in a number of double-

Departments of 1Child Psychiatry and 2Clinical Psychopharmacology, Columbia University, College of Physicians
and Surgeons/New York State Psychiatric Institute, New York, New York.

329
330
blind, placebo-controlled trials (Mitchell et al.
1993; Walsh and Devlin 1995; Walsh et al., 1997).
Fluoxetine has been studied in the largest num-
ber of individuals and has been approved by the
U.S. Food and Drug Administration for the treat-
ment of BN in adults (Fluoxetine Bulimia Ner-
vosa Collaborative Study Group 1992). Despite
the fact that these eating disorders often have
their onset during adolescence, the majority of
the medication trials have been conducted with
adults, and thus their results may not be applica-
ble to younger patients. Recent reports docu-
ment the efficacy and tolerability of the selective
serotonin reuptake inhibitors for adolescent anx-
iety and depressive disorders (Emslie et al. 1997;
Geller et al. 2001; Keller et al., 2001; March et al.
1998; Research Unit on Pediatric Psychopharma-
cology Anxiety Study Group, 2001). Thus it is
reasonable to examine whether treatments that
are efficacious and tolerable for adults with BN
and for adolescents with depression and anxiety
can be adapted for adolescents with BN.
The present study explores the feasibility of
recruiting and maintaining adolescent females
with BN in an open clinical trial of fluoxetine.
It includes an assessment of the tolerability of
an adult dose of fluoxetine (60 mg) in this pop-
ulation and preliminary impressions about the
potential utility of fluoxetine in adolescents with
BN. The study also examines the prevalence of
comorbid anxiety and depressive symptoms in
this population.
METHODS
Subjects
The subjects were female adolescents ages 12–
18 years with a DSM-IV diagnosis of BN or eating
disorder not otherwise specified (EDNOS). Sub-
jects weighed between 85% and 120% of the 50th
percentile for age as determined by standard
growth charts. Exclusion criteria included signifi-
cant medical illness, current psychosis or active
suicidal ideation, drug or alcohol abuse in the past
3 months, pregnancy, and a history of previous
treatment with fluoxetine at 60 mg per day. Sub-
jects were recruited from child psychiatry clinics,
pediatricians, schools, and therapists in the com-
munity. Subjects were interviewed over the phone
to determine preliminary eligibility and to de-
KOTLER ET AL.
scribe the study. Eligible subjects who were inter-
ested were scheduled for an in-person evaluation.
Subjects were not allowed to participate in ongo-
ing psychotherapy outside the protocol.
Assessment procedures
All subjects had a baseline assessment con-
sisting of a psychiatric evaluation, physical ex-
amination, routine lab assessment, a formal
diagnostic interview (Kiddie Schedule for Affec-
tive Disorders and Schizophrenia for School-
Age Children–Present and Lifetime version
[K-SADS-PL]; Kaufman et al. 1997); and ratings
of eating disorder, mood and anxiety disorder
symptom severity and general impairment
scores (Clinical Global Impressions [CGI]-Sever-
ity) (National Institute of Mental Health 1985).
Weekly clinical assessments included BN
symptomatic assessment (binges and purges de-
rived from food diaries); measures of global
clinical response (CGI-Improvement); and as-
sessment of medication compliance, weight,
and side effects. Eating disorder symptom
scales, including the Eating Disorder Inventory
(Garner et al. 1983), Eating Attitudes Test (Gar-
ner and Garfinkel 1979), and Body Shape Ques-
tionnaire (Cooper et al. 1987), were assessed at
baseline and every 4 weeks. Depression and
anxiety symptom self-report scales, including
the Beck Depression Inventory (BDI; Beck et al.
1961) and Self-Report For Childhood Anxiety
Related Disorders (SCARED; Birmaher et al.
1997), were also given at baseline and every 4
weeks of treatment.
Side-effects assessment using the Columbia
Side Effects Scale was done at baseline and at
each week of medication treatment. The fre-
quency of side effects was calculated in two
ways: as the total number of side effects at each
week that were rated as either moderate or se-
vere on the Columbia Side Effects Scale and as
the number of patients who reported moderate
or severe side-effect symptoms at least twice
during the 8-week medication trial, excluding
baseline.
Study procedures
Patients were offered a 4-week supportive
psychosocial treatment phase preceding the 8-
FLUOXETINE IN ADOLESCENTS WITH BULIMIA
week medication trial. Patients who already had
a recent trial of psychotherapy for their eating
disorder or who had significant and impairing
comorbid symptoms could proceed directly to
the 8-week medication trial after baseline eval-
uation. Those who received 4 weeks of support-
ive psychosocial treatment were reassessed after
1 month for the persistence and severity of eat-
ing disorder symptoms. Subjects whose symp-
toms had not significantly improved (defined
as a reduction in binge and purge frequency of
greater than 50%) then entered the 8-week med-
ication treatment phase. Subjects who responded
to the 1-month psychotherapy treatment con-
cluded their participation in the study.
The psychosocial treatment phase consisted
of 4 weeks of 45-minute supportive treatment
including counseling on principles of general
nutrition. The medication treatment consisted
of an 8-week open trial of fluoxetine at 60 mg/
day. Fluoxetine was initiated at 20 mg/day for
3 days, raised to 40 mg/day for 3 days, and
then raised to 60 mg/day.
This study was reviewed and approved by
the New York State Psychiatric Institute Insti-
tutional Review Board. Informed consent was
obtained from parents and from subjects 18
and over. Assent was obtained from subjects
under 18.
Statistical analysis
The primary outcome measures were fre-
quencies of binge eating and purging, as well
as eating disorder, depression, and anxiety self-
report measures. Treatment effects were assessed
with paired t tests (two-tailed) to assess for
change from baseline to week 8 or last obser-
vation carried forward.
RESULTS
Subjects
Over a 3-year period, 71 phone screens were
conducted, which resulted in 19 in-person eval-
uations. Of the 19 evaluations, 13 entered the
study, 1 chose not to enter the study, 2 did not
complete the evaluation process, and 3 were
ineligible for the study. Two subjects required
331
an inpatient level of care and a third was court
mandated for treatment and was thus felt to be
ineligible for research participation. Of the 13
who entered the study, 5 chose to start with the
medication, and these 5 completed the study.
Eight chose to start the study with the 4 weeks
of supportive psychotherapy. Of these 8, 1 im-
proved significantly after therapy alone, and 1
refused to take the medication after the con-
clusion of the 4 weeks of psychotherapy. Three
of the other 6 patients entered the medication
phase after 4 weeks of psychotherapy. The three
remaining patients entered the medication phase
after 2, 2, and 1 week of psychotherapy for
either worsening depressive or eating disorder
symptoms. Of these 3, 1 dropped out after 1
week of medication and the other 2 completed
the medication treatment portion of the study.
Data are presented on the 10 patients who re-
ceived more than 1 week of the medication.
Subjects were all female, with an average age
of 16.2 ± 1.0 years. Five were Caucasian, 3 were
Hispanic, 1 was Asian American, and 1 was In-
dian. On the CGI-Severity scale, 2 were rated
as mild, 1 was moderate, 6 were marked, and 1
was severe. Baseline K-SADS diagnoses for
this sample of 10 subjects were: BN (8), EDNOS
(2), major depressive disorder (6), dysthymia
(2), depressive disorder not otherwise speci-
fied (2), posttraumatic stress disorder (2), gen-
eralized anxiety disorder (3), social phobia (1),
and obsessive-compulsive disorder (1). The 2
subjects who met criteria for EDNOS instead
of BN did so because although they were en-
gaging in purging behavior, they had no objec-
tively large binges at baseline evaluation.
Response to medication treatment
Table 1 presents the means and standard de-
viations for baseline and end-point clinical
variables. Clinical variables that decreased sig-
nificantly include: average weekly binges, aver-
age weekly purges, Eating Disorder Inventory
(Bulimia subscale), Eating Attitudes Test, and
scores on the SCARED. There were no signifi-
cant changes in weight, body mass index, or
scores on the BDI. The time course of change in
binge eating and purging symptoms is shown
in Fig. 1. The CGI-improvement scores were:
much improved for 2 subjects, improved for 5
332 KOTLER ET AL.

TABLE 1. CHANGES IN CLINICAL CHARACTERISTICS FROM Safety and tolerability

BASELINE TO WEEK 8
For all subjects, fluoxetine was initiated at 20
Subjects (n = 10) Baseline Week 8 p
mg/day and titrated to 60 mg/day by day 7 of
Weight (kg) 58.8 ± 6.5 57.9 ± 7.1 ns medication and continued at 60 mg/day for the
BMI (kg/m2) 22.3 ± 2.5 22.0 ± 2.4 ns next 7 weeks. No patient discontinued fluoxe-
Average weekly 4.1 ± 3.8 0 <0.01
binges tine because of side effects. The average number
Average weekly 6.4 ± 5.1 0.4 ± 0.9 <0.005 of symptoms rated as moderate or severe on the
purges Columbia Side Effects Scale was 2.9 at baseline
EAT 56.5 ± 27.2 34.5 ± 20.1 <0.05
EDI (Bulimia 10.6 ± 6.8 4.2 ± 3.9 <0.01 (before initiation of medication) and 0.8 at week
subscale) 8 of the medication trial. The most common side
BSQ 151.1 ± 36.5 131.1 ± 41.3 ns effects reported (during 2 or more weeks of the
BDI 24.3 ± 11.6 16.5 ± 12.0 ns
SCARED 27.9 ± 16.4 17.8 ± 13.6 <0.05
trial) were headache (n = 4), drowsiness (n = 4),
poor concentration (n = 2), difficulty sitting still
BDI = Beck Depression Inventory; BMI = body mass (n = 2), decreased appetite (n = 2), tremor (n = 2),
index; BSQ = Body Shape Questionnaire; EAT = Eating
Attitudes Test; EDI = Eating Disorder Inventory;
difficulty falling asleep (n = 5), and difficulty
SCARED = Self-Report For Childhood Anxiety Related staying asleep (n = 4).
Disorders.

subjects, and slightly improved for 3 subjects. K-
SADS diagnoses after 8 weeks of treatment
with fluoxetine were: BN for 2 subjects and
EDNOS for 1 subject. The 2 patients who met
criteria for BN also had a comorbid disorder,
major depressive disorder in one case and so-
cial phobia in the other case.
DISCUSSION
In an open clinical trial evaluating 8 weeks
of acute therapy with fluoxetine in adolescent
outpatients with BN, fluoxetine was found to
be well tolerated and associated with a signifi-
cant decrease in the core behavioral symptoms
of BN. This is the first case series of which we

FIG. 1. Mean weekly binge and purge frequencies. Time course of change in binge eating and purging from baseline
to week 8 of fluoxetine treatment in adolescents with bulimia nervosa (N = 10).
FLUOXETINE IN ADOLESCENTS WITH BULIMIA
are aware focusing on the use of fluoxetine for
BN in adolescents under 18 years of age.
Our findings are consistent with the placebo-
controlled studies of fluoxetine in adults with
BN. Fluoxetine (60 mg) decreased average
weekly binges by 67% and average weekly
purges by 56% from baseline in a multicenter,
placebo-controlled, double-blind trial of 387
women with BN with a mean age of 27 (Fluox-
etine Bulimia Nervosa Collaborative Study
Group 1992). Subjects given 60 mg of fluoxe-
tine had significant decreases of 3 points on the
Eating Disorder Inventory’s Bulimia subscale
and 8.5 points on the Eating Attitudes Test (26-
item version). We found somewhat larger de-
creases in both of these self-report scales in our
patients, although our patients tended to be
less ill at baseline, with an average binge fre-
quency of 4.1 (vs. 11) per week and an average
purge frequency of 6.4 (vs. 11) per week. Our
subjects had high rates of comorbidity at base-
line, with all 10 having a depressive disorder
and 4 having an anxiety disorder in addition
to the eating disorder.
Although binge eating ceased and purging
decreased to less than once per week after 8
weeks of treatment with fluoxetine, 2 subjects
still met criteria for BN and 1 subject still met
criteria for EDNOS as assessed by the K-SADS
interview. In addition, 3 subjects were rated on
the CGI-Improvement scale as only slightly im-
proved. This highlights the potential differences
between various assessment measures of eating
behaviors. For example, the binge/purge food
diaries were filled out daily by subjects and
were calculated as means per week, whereas the
structured interview asked about eating behav-
iors in the past few weeks. The CGI-Improve-
ment scores may have reflected other symptoms
of BN such as shape and weight concerns, as
well as impairment from these symptoms.
We found a significant improvement in scores
on an anxiety self-report measure (SCARED),
but only a trend toward improvement in BDI
scores. However, all of the subjects met DSM-
IV criteria for a depressive disorder at baseline
and only 1 met criteria for a depressive disor-
der at week 8. This lack of agreement between
self-report ratings of depression and struc-
tured interview results might reflect a time lag
333
in the way subjects perceive improvement in
these symptoms, reporting them sooner in a
structured interview than on a questionnaire.
It also may reflect a power issue with a small
sample size and some variability in symptom
response across patients.
A double-blind, placebo-controlled trial of
fluoxetine 20 mg in children and adolescents
with major depressive episode found that 56%
of those who received fluoxetine and 33% who
received placebo were rated as much or very
much improved in the CGI at study exit (Em-
slie et al. 1997). Differences between the fluox-
etine-treated group and the placebo group were
less evident in self-report scales such as the BDI
or the Children’s Depression Inventory. The
authors state that side effects as a reason for
discontinuation were minimal, affecting only 4
out of 48 patients who received fluoxetine.
Three patients dropped out due to emergence
of manic symptoms, and 1 patient developed a
severe rash. There is no further description of
the percentages of patients who reported vari-
ous side effects but did not drop out of the
trial. A recently published multicenter trial of
fluvoxamine for the treatment of anxiety dis-
orders in children and adolescents reported
the following adverse events: headache (43%),
abdominal discomfort (49%), increased motor
activity (27%), drowsiness (21%), and insomnia
(19%) (Research Unit on Pediatric Psychophar-
macology Anxiety Study Group 2001). These
findings are similar to our experience with flu-
oxetine in adolescents with BN.
Our study had a number of significant limi-
tations. The open design and small number of
patients in this clinical series limit the interpre-
tation of data from the study. As a research clinic
that primarily recruits and treats adults with
eating disorders, it was our impression that it
was more difficult to recruit adolescents with
BN. We are not sure if this was due to a lower
prevalence of the disorder in younger teens, the
guilt and shame inherent in the disorder that
delays presentation for treatment until later teen
years or early adulthood, or various political and
social factors that have made it challenging to
recruit adolescent subjects into treatment stud-
ies that involve medication. Once subjects en-
tered the trial, it was our impression that they
334
did not have a more difficult time completing
the trial than adult patients with BN in compa-
rable medication trials. The trial was only 8
weeks in duration, and thus we can only com-
ment on the acute short-term effects of fluoxe-
tine in adolescents with BN. In addition, except
for the K-SADS interviews, the primary child
psychiatrist did all of the clinical ratings and
was not blind to treatment status.
Our findings suggest that fluoxetine at a dose
of 60 mg/day is a promising treatment option
for adolescents with BN. The medication ap-
peared to be well tolerated in adolescents with
BN and was associated with an impressive de-
crease in binge and purge symptoms. Placebo-
controlled studies with larger sample sizes and
longer periods of treatment are needed to es-
tablish more definitively the efficacy and toler-
ability of medication for BN in this age group.
Although both interpersonal psychotherapy
and cognitive-behavioral psychotherapy have
been shown to be effective in the treatment of
adults with BN, there has been no study of
these treatments for adolescents with the dis-
order (Fairburn et al. 1995; Wilson et al. 1991).
Hence, the role of both medication and psycho-
therapy for adolescents with BN remains a sub-
ject in dire need of further study.
ACKNOWLEDGMENTS
This work was supported by training grant
MH16434 to Dr. David Shaffer, National Institute
of Mental Health Research Training in Child Psy-
chiatry, and by a pilot grant to Dr. Lisa A. Kotler
from the Columbia University Child Psychiatry
Intervention Research Center MH60570 as well
as a Young Investigator Award to Dr. Lisa A.
Kotler from National Alliance for Research on
Schizophrenia and Depression (NARSAD).
The authors thank Katarzyna Bisaga, M.D.
for her assistance on this project.
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E-mail: kotlerl@childpsych.columbia.edu
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