Weekly Formulation of Fluoxetine for
Newly Treated Patients with Depression
Gary S. Kabinoff,
1
John M. Plewes
2
and Michael G. Wilson
3
1 Martin Memorial Medical Center, Stuart, Florida, USA
2 Lilly Research Laboratories, Indianapolis, Indiana, USA
3 College of Pharmacy and Health Sciences, Butler University, Indianapolis, Indiana, USA
SHORT COMMUNICATION
Clin Drug Invest 2002; 22 (6): 403-405
1173-2563/02/0006-0403/$25.00/0
© Adis International Limited. All rights reserved.
Successful pharmacological resolution of
depressive symptoms requires adequacies in the
dosage and duration of antidepressant therapy,
[1]
but these have been seriously less than optimal for
many patients with major depressive disorder
(MDD).
[2]
A significant reason for the lack of suc-
cess in therapy is non-compliance.
[3]
Montgomery
et al.
[4]
postulated that once-weekly drug adminis-
tration might improve compliance because the
burden on patients to remember to take their med-
ication is substantially reduced and drug adminis-
tration is more convenient. The selective serotonin
reuptake inhibitor (SSRI) fluoxetine is the only
agent capable of providing an antidepressant
effect when administered less frequently than daily
because both the parent compound and its
desmethylated metabolite norfluoxetine have long
elimination half-lives.
[5]
Furthermore, a new for-
mulation of enteric-coated fluoxetine has been
shown to be well tolerated, effective
[6]
and associ-
ated with excellent compliance
[7]
when adminis-
tered once weekly to patients who had previously
responded to fluoxetine 20mg daily for short-term
treatment of MDD. This enteric-coated formula-
tion has been approved by regulatory agencies in
North and South America and Europe for continu-
ation treatment of MDD. In a naturalistic study,
Buongiorno et al.
[8]
reported that enteric-coated
fluoxetine administered at higher dosages (90 to
540mg) once weekly was effective and well toler-
ated in the short-term maintenance treatment of
MDD, and was also effective in the seven patients
who had begun treatment de novo. Therefore,
patients with depression who have not been pre-
viously treated may also benefit from this regimen.
Our objective was to examine the efficacy and
tolerability of weekly administration of enteric-
coated fluoxetine in treatment-naïve patients with
depression seen in our clinic in the Southeastern
United States.
Patients and Methods
We retrospectively identified all consecutive
outpatients with a confirmed diagnosis of clinical
and treatment-naïve depression who had been seen
in our clinic and naturalistic environment from
18 May to 15 November 2001, and had been
prescribed weekly treatment with enteric-coated
fluoxetine. The 12 patients identified included
eight women and four men whose ages ranged
from 17 to 71 years. Ten patients had at least one
medical or psychiatric comorbid diagnosis and
seven of those patients were receiving concomitant
medication.
The severity of depressive symptoms was
evaluated at baseline and again at each patient’s
monthly visit to provide an indication of progress.
We used the total of the 17-Item Hamilton Depres-
sion Rating Scale (HAMD
17
) as a measure of
severity of depressive symptoms. In this cohort,
depression severity was classified as mild
(HAMD
17
total score = 10 to 13), moderate