Context.— The generalized type of social phobia (social anxiety disorder) is a
severe and often disabling form of social anxiety that affects approximately
5% of the general population. Earlier research has shown monoamine oxidase
inhibitors or benzodiazepines to be effective in treating this condition,
but neither has achieved widespread use.
Objective.— To compare the efficacy of paroxetine, a selective serotonin reuptake
inhibitor, with placebo in adults with generalized social phobia.
Design.— Twelve-week, multicenter, randomized, double-blind trial.
Setting.— Thirteen centers across the United States and 1 in Canada.
Participants.— Between April 13, 1995, and February 28, 1996, 187 persons meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition criteria for generalized social phobia were randomized (and
183 returned for at least 1 efficacy assessment) to treatment.
Intervention.— After a 1-week, single-blind, placebo, run-in period, patients received
a double-blind, 11-week course of either paroxetine or matching-image placebo.
The initial daily dosage of paroxetine (or placebo) was 20 mg with increases
of 10 mg/d weekly (flexible dosing to a maximum of 50 mg/d) permitted after
the second week of treatment.
Main Outcome Measures.— Number of responders based on the Clinical Global Impression Global
Improvement Item ("much improved" or "very much improved"); mean change from
baseline on the Liebowitz Social Anxiety Scale total score.
Results.— Fifty (55.0%) of 91 persons taking paroxetine and 22 (23.9%) of 92 persons
taking placebo were much improved or very much improved at the end of treatment
(odds ratio [OR], 3.88; 95% confidence interval [CI], 2.81-5.36). Mean Liebowitz
Social Anxiety Scale total scores were reduced by 39.1% (the mean baseline
score of 78.0 declined by a mean of 30.5 points at follow-up) in the paroxetine
group compared with 17.4% (the mean baseline score of 83.5 declined 14.5 points
at follow-up) in the placebo group, a difference of 21.7% (95% CI, 8.7%-34.7%)
favoring paroxetine.
Conclusions.— Paroxetine is an effective treatment for patients with generalized social
phobia. Short-term (ie, 11-week) treatment results in substantial and clinically
meaningful reductions in symptoms and disability. Future research should test
whether these may be further reduced by extended treatment or supplementation
with specific educational-cognitive-behavioral techniques.
SOCIAL PHOBIA, also known as social anxiety disorder, is characterized
by the fear of being observed or evaluated by others.1
In such situations, individuals with social phobia fear that they will say
or do something to embarrass or humiliate themselves or that others will notice
that they are anxious. Consequently, people with social phobia often avoid
situations where such scrutiny might take place or they endure them with intense
distress. Not surprisingly, this can result in impaired functioning and reduced
quality of life.2-6
Patients with social phobia may have few friendships, experience trouble dating,
drop out of school, reject promotions at work, become demoralized and depressed,
abuse alcohol, and develop other psychiatric comorbidities.2-7
Most clinicians associate the term social phobia
with a fear of public speaking. Indeed, social phobia often involves public
speaking and, in some cases, does so exclusively.8
However, it has recently been recognized that there is a subgroup of social
phobic people whose social anxiety is far more pervasive and usually far more
disabling. Persons with this variant of the disorder, known as generalized
social phobia (GSP), typically fear and avoid a broad array of situations
that most people take for granted.4,5,7
Examples might include speaking in small groups (eg, at work or school), attending
social gatherings, talking to people in authority (eg, teachers, employers),
or interacting with peers in informal settings (eg, talking to colleagues
over lunch).
Previously believed to be a rare disorder based on prevalence estimates
from psychiatric clinics, recent epidemiologic surveys have demonstrated that
social phobia is highly prevalent.9-12
After major depression and alcohol dependence, social phobia is the third
most common psychiatric disorder in the general population with lifetime,
12-month, and 30-day prevalence rates of 13.3%, 7.9%, and 4.5%, respectively.9,10 Although precise rates of GSP are
lacking, it is estimated that approximately two thirds of people with social
phobia in the community would fall into this category.13
It is this 4% to 5% of persons in the community who warrant our attention
as suffering from a public health problem of considerable importance.5,13
Social phobia, like many other anxiety disorders,14,15
is highly prevalent in the primary care setting but goes largely undiagnosed
and untreated.16-18
In a recent primary care study, social phobia was noted to be associated with
meaningfully reduced role functioning and sense of well-being.17
In the only in-depth study to date of social phobia in the general medical
health care system, investigators found a 1-month prevalence of 4.9% in a
French primary care clinic but poor recognition of the disorder on the part
of general practitioners.18 Unfortunately,
the low rate of recognition and appropriate treatment reflect the fact that
social phobia remains a largely neglected anxiety disorder.19
This neglect also extends into the area of treatment. Whereas most physicians
equate treating social phobia with the prescription of as-needed β-blockers
or benzodiazepines (which can be useful in treating social phobia limited
to public speaking or other kinds of performance anxiety), these are not useful
in the treatment of GSP.20-24
Because patients with GSP find so many situations frightening, and because
they encounter these situations on a daily, often unpredictable basis, the
use of occasional "as needed" medications for GSP is not an option. Treatment
options for generalized social phobia include monoamine oxidase inhibitors
(MAOIs), reversible inhibitors of monoamine oxidase A (RIMAs), and benzodiazepines.21-27
However, these treatment choices are associated with dietary restrictions
(MAOIs), potential difficulties with withdrawal and dependence (benzodiazepines),
and questionable efficacy in some studies (RIMAs27).
Specific psychotherapies focused on changing maladaptive thoughts and behaviors
(ie, cognitive and behavioral therapies) have also shown considerable promise
in the treatment of social phobia.28-30
Access to these psychotherapies is often limited, however, by an inadequate
supply of trained therapists, insurance barriers, and other cost factors.
Based on their success in the treatment of many mood and other anxiety
disorders,31 the selective serotonin reuptake
inhibitors (SSRIs) have been investigated in the treatment of social phobia.
Case reports and open-label trials had suggested considerable potential for
the treatment of this condition.32-38
In the 2 double-blind, comparative, single-site studies published to date,
sertraline hydrochloride39 and fluvoxamine
maleate40 were more effective than placebo
with relatively small sample sizes of 12 patients39
and 30 patients,40 respectively.
Based on these encouraging preliminary reports, the first double-blind,
randomized, multicentered trial of paroxetine in patients with social phobia
was undertaken. The trial was limited to patients with the generalized subtype
of social phobia (GSP) because of its greater severity and more specific response
(ie, lower placebo-response rate) compared with nongeneralized social phobia
in prior treatment trials.41
This was a double-blind, placebo-controlled trial in patients diagnosed
as having GSP under the guidelines of the Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).1 Investigators at 13 centers
in the United States and Canada (see acknowledgement) participated in this
12-week study. The protocol was approved by the institutional review boards
at all centers. After a complete description of the study to the patients,
written, informed consent was obtained prior to enrollment. A total of 213
patients entered the screening phase of this study (although additional subjects
were excluded at the prescreening phase based on obvious ineligibility for
the protocol). A Structured Clinical Interview for the DSM-IV (SCID)42 (modified by M.B.S.
and Andrea L. Hazen, PhD), which has been shown to reliably distinguish between
generalized vs nongeneralized subtypes (κ=0.84; M.B.S. and Andrea L.
Hazen, PhD, unpublished observations, July 1996), was used to confirm that
GSP was the predominant diagnosis. In addition to meeting DSM-IV criteria for social phobia, patients were required to exhibit
fear and/or avoidance of at least 4 social situations. At least 2 of these
were required to involve interpersonal interactions.
Eligible patients were 18 years of age or older; adults older than 65
years were permitted if they were able to tolerate a starting paroxetine dose
of at least 20 mg/d. Patients who required concurrent psychoactive medication
(except chloral hydrate for insomnia), narcotic analgesics, warfarin sodium,
digitalis glycosides, phenytoin, cimetidine, or sulfonylurea derivatives were
excluded. Patients who had taken any psychotropic agent or β-blockers
within 14 days prior to the study were ineligible, as were those who had received
depot neuroleptics within the previous 12 weeks. Also excluded were patients
with any other Axis I diagnosis that was considered to be clinically predominant
within the previous 6 months. Patients who met DSM-IV
criteria for substance abuse or dependence within 3 or 6 months prior to this
study, respectively, were excluded, as were those judged to be serious suicidal
or homicidal risks. Additional reasons for exclusion were body dysmorphic
disorder, history of seizure disorder, schizophrenia or bipolar affective
disorder, any serious or uncontrolled medical illness or condition that precluded
paroxetine use, electroconvulsive therapy within the previous 3 months, investigational
drug use or participation in a clinical trial within the previous 12 months,
and previous intolerance of or lack of response to paroxetine (no subject
was excluded on this basis). Women who were pregnant, lactating, or not using
a clinically acceptable method of birth control also were ineligible. Finally,
patients with clinically significant abnormal laboratory or electrocardiographic
findings that could not be resolved prior to baseline evaluations were not
included.
Blinding, Randomization, and Treatment
Following initial screening procedures, potential subjects entered a
1-week, single-blind, placebo run-in period, after which a baseline Clinical
Global Impression (CGI) Global Improvement rating was performed. Patients
who were rated no more than minimally improved (CGI Global Improvement rating
>2) and who continued to meet all inclusion criteria were randomized to receive
paroxetine or placebo (identical in appearance). Patients were randomly assigned
in a balanced fashion to the 2 treatment groups (in blocks of 4) using a computer-generated
randomization code for up to 300 patients. For the purposes of blinding, dosage
was referred to as level 1 (20 mg), level 2 (30 mg), level 3 (40 mg), or level
4 (50 mg). Patients received an initial dose of level 1 medication once daily.
After 2 weeks, the dosage could be increased to the next level (ie, in 10-mg
increments) up to level 4 (ie, 50 mg/d) based on clinical response as determined
by the treating physician. Dosage could be reduced to a minimum of level 1
(ie, 20 mg/d) at any time if the physician felt that adverse effects warranted
this adjustment.
Efficacy and Safety Evaluation
Patients were evaluated for safety and efficacy at weeks 1, 2, 3, 4,
6, 8, and 12. Adverse events were also assessed by telephone at week 10. The
primary efficacy variables were (1) the percentage of responders at end point,
defined as those rated on the CGI Global Improvement Item as 1 (very much
improved) or 2 (much improved) and (2) the mean change from baseline at end
point on the Liebowitz Social Anxiety Scale43
total score, which is a 24-question assessment of fear and avoidance of public
and social situations. Secondary efficacy variables included mean changes
from baseline at end point in the Social Avoidance and Distress Scale (a measure
of social avoidance and discomfort44); the
Sheehan Disability Inventory for work, social life, and family life (a measure
of quality of life45); and the fear/anxiety
and avoidance subscales of the Liebowitz Social Anxiety Scale. Safety analyses
included routine adverse-event monitoring and vital-sign assessment.
The proportion of patients achieving a dichotomous response (CGI Global
Improvement score of 1 or 2) was analyzed by logistic analysis using the categorical
modeling procedure of the SAS system (SAS Statistical Software, Cary, NC);
this model included treatment and investigator effects. Changes from baseline
scores of the various efficacy scales were analyzed using parametric analysis
of variance. The general linear model of the SAS system, including treatment
and investigator effects, was used. Type III sums of squares were used. The
treatment-by-investigator interaction was not significant for any variable
and subsequently was removed from the models.
All statistical tests comparing paroxetine with placebo were 2-tailed
and performed at an α of .05. Using a power (1-β) of 0.90 to detect
a difference between paroxetine and placebo responders on the CGI Global Improvement
Item, the target recruitment for the study was set at (180 patients with 90
per group). Efficacy analyses were carried out on the sample of patients with
at least 1 postbaseline efficacy evaluation and those who had received at
least 1 dose of double-blind medication (N=183, referred to herein as the efficacy population). For patients who did not complete
the entire study, the last evaluation during treatment was used as an estimate
of the missing data (ie, last observation carried forward). Data are reported
as mean values (SE), and 95% confidence intervals (CIs) are reported where
appropriate.
Of the 213 patients who were screened, 187 patients were enrolled and
randomized to either paroxetine (n=94) or placebo (n=93) treatment arms (Figure 1). The typical patient was relatively
young (mean age, approximately 36 years) and white. No statistically significant
differences between groups were detected with regard to demographic characteristics
or mean baseline rating scale scores (Table
1). Though not excluded by the protocol, few subjects had current
comorbid major depressive or panic disorder (Table 1).
Of the 187 patients randomized in this study, 4 patients received the
drug but were lost to follow-up prior to the first efficacy evaluation. Therefore,
the efficacy data for the remaining 183 patients (ie, the efficacy population)
are reported. Safety assessments were obtained for all 187 patients who were
randomized.
Premature Discontinuation
In the paroxetine group, 62 (66%) of 94 patients completed the 12-week
trial. The most common reasons for patient withdrawal were adverse events
(15% [14/94]) or lost to follow-up (13% [12/94]). In the placebo group, 72
(77%) of 93 patients (P=.03 vs paroxetine) completed
the trial. The most common reason for discontinuation was lack of efficacy
(11% [10/93]) (Table 2).
Fifty (55.0%) of 91 persons who received to paroxetine and 22 (23.9%)
of 92 persons who received placebo were much or very much improved at the
end of treatment (odds ratio [OR], 3.88; 95% CI, 2.81-5.36). The proportion
of paroxetine responders (ie, CGI Global Improvement score of 1 or 2) was
significantly greater than placebo beginning at week 4 and continuing through
week 12 (Figure 2). No interactions
were found between sex and response (either on the CGI or on the measures
listed below).
The mean change from baseline on the Liebowitz Social Anxiety Scale
total score was more than twice as large in the paroxetine group (−30.5±2.66;
39.1% decrease from mean baseline total score of 78.0) than in the placebo
group (−14.5±2.63; 17.4% decrease from mean baseline total score
of 83.5), a difference of 21.7% (95% CI, 8.7%-34.7%) favoring paroxetine.
Significant differences that were apparent by week 2 continued through the
end of the study (Figure 3).
Paroxetine was significantly superior to placebo on 5 of 6 secondary
efficacy measures (Liebowitz Social Anxiety Scale, avoidance and fear/anxiety
subscales; Social Avoidance and Distress Scale; and Sheehan Disability Inventory,
work and social life) (Table 3).
Although the improvement from baseline at end point for the Sheehan Disability
Inventory family life item was numerically greater with paroxetine (−1.0)
than with placebo (−0.6), this difference was not statistically significant.
The mean dose of paroxetine at study end point was 36.6 mg (SD, 12.1
mg); mean dose of placebo at study end point was dose level 3.5 (SD, 0.90)
(equivalent to 45 mg [SD, 18 mg]).
The reported incidence and severity of adverse experiences in paroxetine-treated
patients were as expected, and no unusual experiences were reported (Table 4). The most frequently occurring
adverse experiences in paroxetine-treated patients were headache (37.2%),
delayed ejaculation (36% of males), somnolence (26.6%), and nausea (25.5%).
In placebo-treated patients, these events occurred at the rates of 32.3%,
0%, 9.7%, and 11.8%, respectively. Most adverse experiences were of mild to
moderate intensity.
This is the first multicenter, double-blind, randomized study of an
SSRI in social phobia (social anxiety disorder). The results clearly demonstrate
that paroxetine treatment effectively reduces the symptoms and avoidance associated
with generalized social phobia. Paroxetine was statistically superior to placebo
on both primary efficacy criteria and on 5 of 6 secondary efficacy variables.
Among the latter, it is noteworthy that disability associated with generalized
social phobia improved significantly as demonstrated by significantly greater
reductions in the Sheehan Disability Inventory work and social life subscales
compared with placebo. Given the early age at onset and chronicity of this
disorder, detecting a reduction in disability after a 12-week trial is noteworthy.
It is hoped, but remains to be shown in future studies, that longer duration
of treatment might result in even further consolidation of gains and reduction
of functional impairment.
Paroxetine was well tolerated in this study as evidenced by the relatively
low incidence of withdrawal because of adverse experiences (15%) and the lack
of serious adverse experiences. The adverse-event profile is in concordance
with the findings of other efficacy and safety studies of paroxetine and other
SSRIs.44-47
As reported in this study, paroxetine was clearly effective for generalized
social phobia. The response to paroxetine therapy among patients with this
most serious and recalcitrant form of social phobia is a rigorous demonstration
of efficacy. Unfortunately, the lack of direct, comparative studies precludes
between-treatment efficacy comparisons. To the extent that indirect comparisons
are valid, the response rate to paroxetine in this generalized social phobia
study (55% in the efficacy population) compares favorably with double-blind,
placebo-controlled study response rates of 52% for moclobemide (severely ill
subset)26; 68% for phenelzine sulfate (GSP
subset)41; and 78% for clonazepam.25 The response rate to paroxetine in this study is
particularly notable when the fact that this was a 13-center study is taken
into account. In such studies, drug-placebo differences often tend to be less
robust than those in the hands of highly expert investigators at single-center
sites.
Although the benzodiazepines, MAOIs, and other pharmacological treatments
have been shown to be effective for generalized social phobia,21-26,41
there are some relative disadvantages as well. High-potency benzodiazepines
have limited antidepressant effects, which is an important consideration in
a disorder for which major depression is commonly comorbid.2,10,13
The benzodiazepines have the potential for abuse or misuse and can also cause
physical dependence with long-term use. Nonselective MAOIs sometimes cause
unpleasant activation or a hypomanialike effect, postural hypotension, and
other adverse effects and require dietary restriction to avoid hypertensive
reactions; all of these can limit clinical acceptance by physicians and patients.
In this study, paroxetine had a side effect profile consistent with its use
in other mood and anxiety disorders. In general, these side effects tend to
be benign, leading to good patient tolerance (with the possible exception
of the relatively high rate of abnormal ejaculation in men; although only
2 of 16 men with this side effect elected to discontinue treatment prematurely
as a result). Based on its efficacy, safety, and relatively good tolerability,
paroxetine can be considered among the first-line treatments for social phobia.
Given the experience that all SSRIs tend to be effective for those conditions
in which any have demonstrated efficacy, we would surmise that efficacy for
the treatment of generalized social phobia will eventually be shown to extend
to other SSRIs as well.
There are a number of limitations to this study. Social phobia is a
chronic, potentially disabling disease that may require long-term therapy.
By design, this study did not assess treatment effects beyond the acute, 12-week
treatment period. It is possible, albeit not yet proven, that a longer course
of therapy could result in continued and even greater reductions in impairment
and in improvement in quality of life. A previous study suggested that relapse
rates may be very high when treatment with paroxetine is discontinued after
only 12 weeks of treatment.38 Further studies
of long-term treatment with paroxetine are warranted to determine optimal
duration of therapy, efficacy in sustaining remission, and the role of concomitant
psychotherapy (eg, cognitive behavioral therapy), which can be effective for
many patients with this condition.28-30,48
Another limitation of this study is its inability to definitively demonstrate
that reductions in social phobic symptoms were not merely a secondary manifestation
of an antidepressant effect. Although few patients (4.8%) in this study had
comorbid major depressive disorder at the time of entry into the study, it
is possible that other patients may have had subsyndromal symptoms that could
be antidepressant responsive. The next study with an SSRI for social phobia
should measure depressive symptoms throughout the trial to determine whether
or not these appear to drive the reduction in social anxiety symptoms.
In conclusion, this controlled clinical trial confirmed the suggestions
from earlier reports and demonstrated that paroxetine is an effective and
well-tolerated treatment for patients with generalized social phobia. Future
research should address questions of optimal dose and duration of treatment,
as well as the potential utility of educational and psychotherapeutic strategies
to augment response and/or reduce relapse.
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