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The objective in
this randomized, double-blinded, placebo-controlled study was to examine the
benefit of using citalopram to treat non-depressed patients with mild to
moderate alcohol dependence. The trial focused on the difference in outcomes
comparing men and women. This study included 61 participants of whom 34 were
men and 27 were women. Subjects were included if they consumed at least 28
drinks per week for at least 3 months and demonstrated mental and social
stability as well as if they met the criteria for mild to moderate alcohol
dependence assessed by the Alcohol Dependence Scale (ADS), Michigan Alcohol
Screening Test (MAST) and the Diagnostic Statistical Manual of Mental
Disorders, 3rd edition, revised (DSM-III-R). Subjects were excluded
if they had a prior additional drug or substance addiction, were clinically
depressed, or diagnosed with an anxiety or psychiatric disorder. Once recruited
for the study, subjects underwent a single-blind two-week baseline treatment
with a placebo to determine response to the placebo alone. Those who met the
inclusion criteria after the two-week placebo trial were then divided into two
groups: the treatment group and the placebo group. In the treatment group (n=
16 men, 15 women), the subjects were provided with 40 milligrams of citalopram
by mouth once daily and a brief psychosocial intervention (BPI) for 12 weeks.

Subjects in the placebo group (N=18 men, 12 women) received the placebo by
mouth once daily and BPI for 12 weeks. The primary outcome of the study was to
examine the fluctuation of alcohol dependence between males and females
determined by the ADS and MAST. Secondary outcomes included other psychiatric
alterations as determined by the Montgomery-Åsberg Depression Rating Scale
(MADRS) and the State-Trait Anxiety Inventory. Subjects were told to take
medication at 8 pm and provide urine for analysis two to four hours following,
which would either confirm or deny alcohol consumption and adherence to
treatment. Subjects were required to return for scheduled visits at weeks 2, 4,
6, 8 and 12. At these visits, subjects had an analysis of blood and urine, BPI
and were asked to complete questionnaires to determine dependence. The p-value
was set at 0.05, although the study failed to provide exact p-values for
comparisons. The study examined the mean drinks per day comparing males and
females and showed citalopram had an additional 16.57% decrease from baseline
in men (p

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            Before
this study was initiated, most of the previous studies on selective serotonin
reuptake inhibitors (SSRI) in alcohol dependence were done primarily on men.

This trial studied the effects on both men and women as well as the differences
between them. The duration of the study was brief at only 12 weeks, making it
hard to effectively draw conclusions about relapse and outcomes after the study
without further follow-up information. The study stated it published most of
the results elsewhere, including liver function tests, perception of treatment
and post-treatment MAST and ADS scores. These results would be helpful in
assessing a more complete picture of effectiveness. One key baseline difference
was the MAST scores in the treatment group during initiation of the trial,
which showed men at 10.4±0.8 and women at 6.4±0.9 (p>0.05). Anything over
five indicated problems with drinking. This allowed for a higher margin of
improvement for men than women and could have been avoided by an equal
distribution amongst groups. This study was supported by a grant from Lundbeck
Pharmaceuticals. This could be a conflict of interest as the company
manufactures citalopram. The company would benefit from another indication for
their medication.  Although there were
many secondary outcomes mentioned, the study only demonstrated a statistical
difference in the decline of mean drinks per day between men and women. This
study provided a precedent for gender differences in the treatment of alcohol
dependence with citalopram.

            This
study was a randomized, double-blind, placebo-controlled trial that sought to
demonstrate that the treatment of alcohol dependence with citalopram produces
undesired results. The study recruited subjects (N=265) and randomized them
into two groups for a length of 12 weeks (N= 127 in placebo group and N=137 in
treatment group). Participants were included if they were 18-65 years old and
met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition
(DSM-IV) diagnosis of alcohol dependence. Participants were excluded from the
trial if they had concurrent addiction to an additional substance and a
psychiatric disorder, if they were pregnant or breastfeeding, intolerant or
allergic to SSRI, and if they were required to be admitted to inpatient for
alcohol detoxification or psychiatric issue. The treatment group received 20
milligrams of citalopram by mouth once daily for the first week and 40
milligrams of citalopram once daily for the rest of the treatment. Both the
placebo group and the treatment group underwent weekly individual and group
psychotherapy. Subjects were examined at week 12 to determine their alcohol
addiction, any symptoms of depression, and any other psychiatric disorders. The
p-value was set at 0.05. The primary outcome was the reduction of alcohol use,
which showed that the placebo group had a 16.8% higher reduction in the number
of days of alcohol use from baseline compared to the treatment group (p=0.016).

The placebo group also had a 20.62% reduction in the mean drinks per drinking
day when compared to treatment group (p=0.025). Further comparison of secondary
outcomes between the groups included the Hamilton Rating Scale for Depression
(p=0.892), Beck Depression Inventory (p=0.841), and Beck Anxiety Inventory
(p=0.800); all of which did not demonstrate a statistical difference. The study
concluded that citalopram should not be used in the treatment of alcohol
dependence for the inferior outcomes associated.

            This study contradicts the findings
in the previous trial. The study contained more subjects and provided analysis
of the groups focused on the change from baseline instead of variations between
men and women.  This study stated that
many subjects (n=124) had to withdraw from the trial because of worsening of
psychiatric symptoms or adverse effects. However, follow up information from
204 of the subjects was obtained. This furthers their conclusion about
citalopram and indicated that the trial could have been done for shorter time
due to harm or absence of effective treatment. The study used a noteworthy
amount of men (n=185) compared to women (n=80). The previous trial had shown a
response difference to treatment between men and women. It would be helpful to
separate these results into two separate categories or recruit equal amounts to
accurately rule out clinical importance. Although detoxification was part of
the exclusion criteria, it allowed subjects to receive a diazepam tapering
regimen for 14 days prior to the trial if clinically indicated. This occurred
in the treatment group significantly more than the placebo group (n=60 vs.

n=33, p

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