Liebowitz Social Anxiety Scale Total Score Research Articles

Effectiveness of eye communication training device for social anxiety disorder treatment: A single-arm pilot trial

BackgroundSocial anxiety disorder (SAD) is a common mental disorder that is characterized by severe anxiety in social situations. Individual cognitive-behavioral therapy (CBT) for SAD is the recommended first treatment, but there is a critical shortage of CBT-trained therapists. People with SAD often fear and avoid making eye contact, which can lead to social anxiety and difficulty functioning in daily life. If they become able to make eye contact more comfortably, their social life should improve. We developed a gaze training system (Eye Communication Trainer: ECOM) to treat SAD. This study aimed to investigate the efficacy and feasibility of ECOM in the single-arm, uncontrolled trial. MethodsThe ECOM gaze training program consists of 8 weekly sessions. In each session for 20 min, subjects watched forty 30-second videos to practice visual control. The effectiveness of the training was evaluated at baseline, week 4 (mid-point), week 8 (completion), and week 12 (follow-up). The primary outcome was the Liebowitz Social Anxiety Scale (LSAS). The secondary outcomes were Social Phobia Inventory (SPIN), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and EuroQol 5 dimensions (EQ-5D). ResultsTwenty-three subjects participated in the study. One subject did not complete the follow-up. The LSAS total score decreased significantly at week 8 (Hedges' g = 1.35, n = 23) and at week 12 (Hedges' g = 1.80, n = 22). The subjects also showed significant improvement in all secondary outcomes. No adverse events, except dry eye, were reported. ConclusionThe ECOM gaze training shows potential as a new treatment for SAD.

The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study

JNJ-42165279 is a selective inhibitor of fatty acid amide hydrolase (FAAH), the enzyme responsible for the degradation of fatty acid amides (FAA) including anandamide (AEA), palmitoylethanolamide (PEA), and N-oleoylethanolamide (OEA). We assessed the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with JNJ-42165279 in subjects with social anxiety disorder (SAD). This was a multicenter, double-blind, placebo-controlled study randomizing subjects to 12 weeks of treatment with either JNJ-42165279 (25 mg daily) or placebo (PBO). The primary endpoint was the change in the Liebowitz Social Anxiety Scale (LSAS) total score from baseline to end of study. Secondary endpoints included the Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS17), and the Clinical Global Impression-Improvement (CGI-I). Samples were collected for plasma concentration of AEA, PEA, OEA, and JNJ-42165279. A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84). The mean change from baseline (SD) in LSAS total score at week 12 was numerically greater for JNJ-42165279: −29.4 (27.47) compared to PBO: −22.4 (23.57) but not significant. The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04). The percentage of subjects with a CGI-I score of much or very much improved was also significantly higher for JNJ-42165279 (44.1%) than for PBO (23.6%) (p value = 0.02). The drug was well tolerated. JNJ-42165279 appears to elicit an anxiolytic effect in subjects with SAD although trough concentrations with 25 mg once daily appeared to be insufficient to completely inhibit FAAH activity which may have led to suboptimal efficacy. ClinicalTrials.gov Identifier: NCT02432703.

The long-term effects of microvascular decompression on social phobia and health-related quality of life in patients with hemifacial spasm: a 3-year prospective study.

Although not a life-threatening condition, hemifacial spasm (HFS) frequently leads to social phobia because it causes significant facial disfigurement and consequently reduces health-related quality of life (HRQoL). The purpose of the current study was to examine the long-term effects of MVD on psychological aspects and HRQoL in HFS patients with social anxiety over a 36-month follow-up. Thirty patients with HFS who underwent MVD from January 2015 to May 2015 were included in this prospective study. Clinical data, including standardized measures of general anxiety and depression (Hospital Anxiety Depression Scale (HADS)), social anxiety (Liebowitz Social Anxiety Scale (LSAS)), and the severity of HFS, were collected postoperatively, and 6months and 36months after MVD. Likewise, data on HRQoL were collected at baseline, and 6months and 36months after MVD using the Korean version of the Short Form 36 (SF-36). Twenty-two patients who completed the 36-month follow-up were classified into social phobia group and non-social phobia group based on the LSAS total scores of 60. Repeated measures analysis of variance demonstrated significant differences between the two groups over time for the total LSAS score (p < 0.001), anxiety subscale score of the HADS (p = 0.002), and the Mental Component Summary (MCS) (p = 0.046) of the SF-36. A comparison of these two groups in terms of differences observed in their scales at 6months after MVD has shown that the improvements of the social phobia group in HADS anxiety subscale (p = 0.010), LSAS total score (p = 0.008), and MCS (p = 0.040) were significantly more improved than the those of non-social phobia group. And at 36months after surgery, the improvement of the scales mentioned above was maintained, and additionally Vitality (p = 0.040) and Mental Health (p = 0.040) dimensions showed a statistically significant improvement. The improvements previously observed in psychological aspects and HRQoL over a short-term follow-up after MVD in HFS patients with social phobia were maintained for at least 36months after MVD.

P.3.b.030 - The mRNA expression status of the 5-HT2A receptor in blood peripheral mononuclear cells of schizophrenia patients: biomarker of the efficacy of olanzapine treatment

Escitalopram is the most selective of the serotonin reuptake inhibitor (SSRI) antidepressants. We conducted a meta-analysis of placebo-controlled studies where escitalopram was used to treat patients with social anxiety disorder (SAD). Data from all randomised, double-blind placebo-controlled studies in SAD with escitalopram from both specialist settings and general practice were used. Patients met the DSM-IV criteria for SAD, were ≥18 years old, and had a Liebowitz Social Anxiety Scale (LSAS) ≥60. The primary outcome measure was the estimated treatment difference in LSAS total score at Week 12. Secondary outcome measures included the estimated treatment difference in the Clinical Global Impression-Severity (CGI-S) score at Week 12. A total of 1598 patients from 3 randomised controlled trials were included in the analyses. Escitalopram (n=1061) was superior to placebo (n=537), with an estimated treatment difference on the LSAS of −9.2 points (95%CI: [−14.4; −4.0], p<0.01) (escitalopram 5 mg/day), −4.6 points (95%CI: [−8.1; −1.0], p<0.01) (escitalopram 10 mg/day), −10.1 points (95%CI: [−13.7; −6.5], p<0.01) (escitalopram 20 mg/day) and −7.3 points (95%CI: [−12.3; −2.2], p<0.01) (escitalopram 10-20 mg/day). For the CGI-S, the corresponding values were −0.55 points (95%CI: [−0.79; −0.31], p<0.01) (escitalopram 5 mg/day), −0.26 points (95%CI: [−0.42; −0.10], p<0.01) (escitalopram 10 mg/day), −0.48 points (95%CI: [−0.64; −0.31], p<0.01) (escitalopram 20 mg/day) and −0.29 points (95%CI: [−0.51; −0.07], p<0.05) (escitalopram 10-20 mg/day). The withdrawal rate due to adverse events was 7.2% for escitalopram, compared with 4.3% for placebo (p<0.05). In this meta-analysis, all doses of escitalopram showed significant superiority in efficacy versus placebo in the treatment of patients with SAD.

Early Improvement in One Week Predicts the Treatment Response to Escitalopram in Patients with Social Anxiety Disorder: A Preliminary Study.

ObjectiveSocial anxiety disorder (SAD) shows relatively delayed responses to pharmacotherapy when compared to other anxiety disorders. Therefore, more effective early therapeutic decisions can be made if the therapeutic response is predictable as early as possible. We studied whether the therapeutic response at 12 weeks is predictable based on the early improvement with escitalopram at 1 week.MethodsThe subjects were 28 outpatients diagnosed with SAD. The subjects took 10–20 mg/day of escitalopram. The results of the Liebowitz social anxiety scale (LSAS), Hamilton anxiety rating scale, and Montgomery-Asberg depression rating scale were evaluated at 0, 1, 4, 8, and 12 weeks of treatment. Early improvement was defined as a ≥10% reduction in the LSAS total at 1 week of treatment, and endpoint response was defined as a ≥35% reduction in the LSAS total score. The correlation between clinical characteristics and therapeutic responses was analyzed by simple linear regression. The correlation between early improvement responses and endpoint responses was analyzed by multivariate logistic regression analysis and receiver operating characteristic curves.ResultsWhen we adjusted the influence of a ≥35% reduction in the LSAS total endpoint score on a ≥10% reduction of the LSAS total score at 1 week of treatment for the patients’ age, the early improvement group at 1 week of treatment was expected to show stronger endpoint responses compared to the group with no early improvement.ConclusionThe results suggest that a ≥10% reduction in the LSAS total score in a week can predict endpoint treatment response.

Efficacy of escitalopram in the treatment of social anxiety disorder: A meta-analysis versus placebo

Escitalopram is the most selective of the serotonin reuptake inhibitor (SSRI) antidepressants. We conducted a meta-analysis of placebo-controlled studies where escitalopram was used to treat patients with social anxiety disorder (SAD). Data from all randomised, double-blind placebo-controlled studies in SAD with escitalopram from both specialist settings and general practice were used. Patients met the DSM-IV criteria for SAD, were ≥18 years old, and had a Liebowitz Social Anxiety Scale (LSAS) ≥60. The primary outcome measure was the estimated treatment difference in LSAS total score at Week 12. Secondary outcome measures included the estimated treatment difference in the Clinical Global Impression-Severity (CGI-S) score at Week 12. A total of 1598 patients from 3 randomised controlled trials were included in the analyses. Escitalopram (n=1061) was superior to placebo (n=537), with an estimated treatment difference on the LSAS of −9.2 points (95%CI: [−14.4; −4.0], p<0.01) (escitalopram 5mg/day), −4.6 points (95%CI: [−8.1; −1.0], p<0.01) (escitalopram 10mg/day), −10.1 points (95%CI: [−13.7; −6.5], p<0.01) (escitalopram 20mg/day) and −7.3 points (95%CI: [−12.3; −2.2], p<0.01) (escitalopram 10-20mg/day). For the CGI-S, the corresponding values were −0.55 points (95%CI: [−0.79; −0.31], p<0.01) (escitalopram 5mg/day), −0.26 points (95%CI: [−0.42; −0.10], p<0.01) (escitalopram 10mg/day), −0.48 points (95%CI: [−0.64; −0.31], p<0.01) (escitalopram 20mg/day) and −0.29 points (95%CI: [−0.51; −0.07], p<0.05) (escitalopram 10-20mg/day). The withdrawal rate due to adverse events was 7.2% for escitalopram, compared with 4.3% for placebo (p<0.05). In this meta-analysis, all doses of escitalopram showed significant superiority in efficacy versus placebo in the treatment of patients with SAD.

High social anxiety and poor quality of life in patients with pulmonary tuberculosis.

Pulmonary tuberculosis (PT) has been previously related with various psychosocial adverse consequences including stigmatization and social isolation.Social anxiety is a psychiatric condition that may be associated with social isolation and fear of social exclusion.To date no study has investigated social anxiety and its impact on quality of life (QoL) among patients with PT. Therefore, we aimed to determine the severity of social anxiety in a group of patients with PT.Among patients who were recently discharged from hospital with the diagnosis of PT 94 patients and 99 healthy control subjects who had similar demographical features have been included in the study. A psychiatrist interviewed all participants and a semistructured interview form, which was prepared by the authors, Liebowitz Social Anxiety Scale (LSAS), and Short Form-36 were administered to them.Patients with PT showed higher levels of performance avoidance and social avoidance than healthy control subjects. They reported lower QoL scores across all dimensions. Among patients women showed higher levels of LSAS subscale scores and total score. Fear of social exclusion was predicted by perceived illness severity and emotional role difficulty. On the other hand, perceived illness severity was predicted by fear of exclusion and sedimentation level.PT patients seem to experience higher levels of social anxiety and associated fear of social exclusion that add to their worse QoL during the earlier months of their disease. Among them fear of social exclusion is related with perceived illness severity.

A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Desvenlafaxine Extended-Release Tablets in Generalized Social Anxiety Disorder

Abstract Objective: The purpose of the study was to asses the efficacy of desvenlafaxine in patients with the generalized form of Social Anxiety Disorder (GSAD). Methods: 63 patients with GSAD were randomized to desvenlafaxine or placebo in a 12 week double blind trial. Change from baseline to endpoint on the Liebowitz Social Anxiety Scale (LSAS) was the primary outcome measure. Secondary outcome measures included response, defined as much improved or very much improved on the Clinical Global Impression of Change (CGI-I) and remission rates (defined as the proportion of patients with an endpoint LSAS total score of 30 or less. Changes in depression and anxiety, measured by the Hamilton Depression (Ham-D 17) and Anxiety Scales (Ham-A), were also assessed. Outcome analyses were performed in the intent to treat (ITT) and completer samples. Results: The mean baseline LSAS was 92.8 and mean Clinical Global Impression of Severity (CGI-S) was 5.4, indicating severe illness, with no baseline differences between treatment groups. At the end of treatment, in the ITT sample (N=58), the drug group had improved more than the placebo group by 9.7 points on the LSAS, a trend difference (p=0.085, 1 tailed). Cohen’s d was 0.36, indicative of a moderate effect size. There were also trend differences in response (69% versus 48.3%, p=0.09, 1 tailed) and remission rates (20.7% versus 3.4%, p=0.051, t tailed), and significant differences on the Hamilton Depression scale (2.5 versus 0.3, p=0.02, 1 tailed) in favor of desvenlafaxine. Findings in the completer sample were similar to those in the ITT sample. Conclusions: These findings must be considered preliminary because the limited sample size reduced statistical power and renders interpretation of the findings less precise.. Nevertheless these initial results suggest that desvenlafaxine has efficacy for social anxiety disorder similar to that seen with more extensively studied medications that have received FDA approval for this condition. Therefore, pending further study, desvenlafaxine may prove to be a useful treatment for Social Anxiety Disorder.

2165 – Clinical study on the efficacy and tolerability of escitalopram in patients diagnosed with social anxiety

Social anxiety disorder represents a substantial public health problem because is a relative common mental disorder and has a high prevalence and lifelong chronicity. The fact that serotonergic agents is considered to be effective for its treatment suggests that patients may have an abnormal serotonergic neurotransmission. Selective serotonin reuptake inhibitors are effective in the treatment of social anxiety disorder and are currently perceived as the pharmacotherapy of choice. We investigated the efficacy and tolerability of escitalopram in the treatment of generalised social anxiety disorder. Patients with generalised social anxiety disorder were randomised to receive placebo (n = 61) or10-20 mg escitalopram (n = 60) in a 12-week, double-blind study. The primary outcome measure was the mean change from baseline to last assessment in the Liebowitz Social Anxiety Scale (LSAS) total score. The study showed a statistically superior therapeutic effect for escitalopram compared with placebo on the LSAS total score (p = 0.005).There were significantly more responders to treatment for escitalopram than for placebo (68% v. 28%; p < 0.005). The clinical relevance of these findings was supported by significant reduction in the work and social components of the Sheehan Disability Scale and by the good tolerability of escitalopram treatment. These data suggest that escitalopram was efficacious and well tolerated in the treatment of social anxiety disorder. Further studies are needed on larger groups of patients to certify these results.

Lower subjective quality of life and the development of social anxiety symptoms after the discharge of elderly patients with remitted schizophrenia: a 5-year longitudinal study

ObjectivesRemitted schizophrenic patients living in the community often encounter difficulties in their daily lives, possibly leading to the development of social anxiety symptoms. Although several studies have reported the significance of social anxiety as a comorbidity in patients with schizophrenia, few longitudinal data are available on the development of social anxiety symptoms in patients with remitted schizophrenia, especially in association with the process of “deinstitutionalization.” The aims of this study were to assess the social anxiety symptoms in remitted outpatients with schizophrenia and to examine whether the development of social anxiety symptoms was associated with psychotic symptoms, social functioning, or subjective quality of life. MethodsFifty-six people with schizophrenia who were discharged through a deinstitutionalization project were enrolled in this longitudinal study and prospectively assessed with regard to their symptoms, social functioning, and subjective quality of life. The severity of social anxiety symptoms was measured using the Liebowitz Social Anxiety Scale (LSAS). Global/Social functioning and subjective quality of life were evaluated using the Global Assessment of Functioning Scale, the Social Functioning Scale, and the World Health Organization–Quality of Life 26 (WHO-QOL26). ResultsThirty-six patients completed the reassessment at the end of the 5-year follow-up period. The mean LSAS total score worsened over time, whereas other symptoms improved from the baseline. The mean WHO-QOL26 score in the worsened LSAS group was significantly lower than that in the stable LSAS group. At baseline, WHO-QOL26 scores were associated with an increase in the severity of social anxiety symptoms. ConclusionIn community-dwelling patients with remitted schizophrenia, a lower subjective quality of life might lead to the development of social anxiety symptoms, both concurrently and prospectively. To achieve a complete functional recovery, additional interventions for social anxiety may be needed.

Comparison of Anxiety-Related Traits Between Generalized and Nongeneralized Subtypes of Social Anxiety Disorder

This study aimed to investigate the possible difference in anxiety-related traits between the generalized and nongeneralized subtypes of social anxiety disorder (SAD). Two hundred seventy-three SAD Korean outpatients completed the Anxiety Sensitivity Index (ASI), the Trait Form of the State-Trait Anxiety Inventory (STAI-T), Retrospective Self-Report of Inhibition (RSRI), and the Liebowitz Social Anxiety Scale (LSAS) as part of their assessments. The unadjusted total scores of the ASI, STAI-T, RSRI, and LSAS differed between the two subtypes, according to an independent t-test. However, this result was not significant (ASI: F = 2.363, p = 0.127; STAI-T: F = 0.004, p = 0.949; RSRI: F = 1.518, p = 0.220) after adjusting for LSAS total score. The comparison of anxiety-related traits did not show any difference between the subtypes after adjusting for illness severity. These results may suggest that the two SAD subtypes are on a continuum of the same illness, differentiated only by symptom severity.

Double-blind comparison of 30 and 60 mg tranylcypromine daily in patients with panic disorder comorbid with social anxiety disorder

Our objective was to explore the dose–response relationship in patients with panic disorder and social anxiety disorder comorbidity (DSM-IV). After 1 week of no-drug washout, 36 such patients were assigned to a double-blind controlled comparison of the effects of 30 mg and 60 mg of tranylcypromine, and were followed up for 12 weeks. The main instrument used to measure the number of panic attacks was the Sheehan Panic and Anticipatory Anxiety Scale. The primary outcome measure for social anxiety disorder symptoms was the mean change from baseline in the Liebowitz Social Anxiety Scale (LSAS). After 12 weeks of treatment, panic attacks were reduced 69.6% from baseline in the 30-mg group ( n = 19) compared with a 74.8% reduction in the 60-mg group ( n = 17). Twelve patients (70.6%) of the higher dose group and 14 patients (68.4%) of the lower dose were completely free of panic attacks. There was no difference in efficacy between the tranylcypromine groups in the panic disorder symptoms. The 60-mg dose was more efficacious as measured by the LSAS scores, showing a significant difference in relation to the lower group. Mean change from baseline in LSAS total score (mean ± SD) for 30-mg group was − 17.9 ± 14.7 and for the 60-mg group was − 35.0 ± 14.8. The social anxiety symptom scale showed a two-fold greater change with the 60-mg dose, and the 30-mg dose group could be considered the equivalent of a placebo control group. Tranylcypromine – 60 mg daily – was found effective in the treatment of panic disorder and social anxiety disorder comorbidity.

Levetiracetam in Generalized Social Anxiety Disorder

This multicenter, double-blind, placebo-controlled, 2-arm, parallel-group study was carried out to determine the effectiveness and safety of the novel anticonvulsant levetiracetam for the treatment of generalized social anxiety disorder (GSAD). After a 1-week, single-blind, placebo run-in period, 217 adult outpatients meeting DSM-IV criteria for social anxiety disorder, generalized type, were randomly assigned (1:1) to 12 weeks of double-blind treatment with either levetiracetam (n = 111) or placebo (n = 106). Participants were required to have scores of >or= 60 on the Liebowitz Social Anxiety Scale (LSAS) and a total score of <or= 17 on the 17-item Hamilton Depression Rating Scale (HDRS). The primary outcome measure was mean change from baseline on LSAS total score. Levetiracetam was initiated at 250 mg/d and flexibly titrated up to a maximum dose of 3,000 mg/d (1,500 mg bid). Dosage was held stable for the last 6 weeks of treatment. The study was conducted from September 2003 to June 2004. No statistically significant difference was found between the adjusted mean changes in LSAS score for levetiracetam (-24.4) and placebo (-28.7) using an efficacy intent-to-treat, last- observation-carried-forward analysis. Rates of response (>or= 30% reduction in LSAS score) were similar with 41.3% (levetiracetam) and 46.6% (placebo). No significant between-group differences were found on secondary outcome measures, which included changes in Sheehan Disability Scale, Clinical Global Impression of Change, and HDRS scores. Although well-tolerated, levetiracetam failed to separate from placebo in this trial for the treatment of moderate to severe GSAD.

Gabapentin and Tiagabine for Social Anxiety

Sir: Social anxiety disorder is characterized by fear and avoidance of social situations in which patients may feel scrutinized and considered foolish by others.1 Social anxiety disorder can significantly impair educational, social, occupational, and physical functioning.2 Selective serotonin reuptake inhibitors have been the first line of treatment, but only a modest remission rate has been noted.2 Selective serotonin reuptake inhibitors have gastrointestinal, activating, and sexual side effects that limit their utility. Benzodiazepines have been the second-line treatment for social anxiety disorder, mainly due to their potential for dependence and abuse.3 Two newer drugs, tiagabine and gabapentin, have been used in the treatment of anxiety disorders.4–6 Tiagabine is a highly selective inhibitor of the γ-aminobutyric acid (GABA) transporter system (GAT-1).4 Gabapentin is a mixed-type inhibitor of GABA transaminase.7 A small study was conducted at Eastern Virginia Medical School, Department of Psychiatry, in Norfolk, Va. from 2005 through 2007 after approval by the institutional review board that looked at the effectiveness of these 2 drugs in social anxiety disorder. Method. Participants were 8 adults aged 21 to 39 years (mean, 26.5): 5 men and 6 white subjects, 1 black subject, and 1 Asian subject. Inclusion criteria were subjects who were aged 18 to 65 years, male or female, generally healthy, able to provide informed consent, and diagnosed with social anxiety disorder, which was confirmed by DSM-IV criteria and a Liebowitz Social Anxiety Scale (LSAS)8 score greater than 30. Participants were excluded if they had another current Axis I psychiatric disorder, had a major medical illness, were taking medications that interacted with the study drugs, were actively using alcohol or illegal drugs, or were pregnant, planning to become pregnant, or breastfeeding. The study was a randomized, double-blind, crossover design of 4 to 5 months’ duration. Subjects had a washout period of 2 weeks if they were taking any medication for social anxiety disorder. They received a physical exam, a complete blood count, and a comprehensive metabolic panel. When patients successfully completed this phase, they were then randomly assigned to either tiagabine or gabapentin. Subjects had a 2-week titration to the full dosage of treatment arm A medication prior to a four-week stable dosage regimen. A 2-week washout period occurred between treatment arms. Treatment arm B included a 2-week titration and a 4-week stable dosage regimen. Patients were seen for a final visit 2 weeks after stopping study medication. The full daily doses were 2400 mg for tiagabine and 1800 mg for gabapentin. During each visit, the subject completed the LSAS, one of the most commonly used instruments for assessing social anxiety disorder.9,10 Results. Seven subjects had an initial LSAS score in the severe range, with 1 subject in the moderate range. All subjects with severe social anxiety disorder responded well to either anticonvulsant, with 2 subjects (1 for each study drug) reaching remission (LSAS < 30). On the LSAS total score, 4 subjects (2 receiving tiagabine and 2 receiving gabapentin) had clinically significant change (20 points). Patients reported very few side effects, with sedation and mild dizziness being the most common. It appears that both gabapentin and tiagabine can be effective in reducing symptoms of social anxiety disorder as measured by the LSAS. Both medications were well tolerated, with only 1 person stopping gabapentin secondary to sedation. This small study adds to the existing database stating that the anticonvulsants gabapentin and tiagabine can be efficacious in the treatment of social anxiety disorder, with a favorable side effect profile compared to the selective serotonin reuptake inhibitor and benzodiazepine treatment choices. Maria R. Urbano, M.D. David R. Spiegel, M.D. Nena Laguerta, M.D. Catherine J. Shrader, B.S. Daniel F. Rowe, B.S. Liana F. Hategan, M.D. Department of Psychiatry, Eastern Virginia Medical School, Norfolk, Virginia

Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder

To evaluate the effect of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n=224) or placebo (n=218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O-S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. ATX mean change (-8.7+/-10.0) from baseline (29.6+/-10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6+/-10.2) from baseline (31.2+/-9.4; P<.001). ATX mean change (-22.9+/-25.3) from baseline (85.3+/-23.6) on LSAS Total score was significant compared to placebo mean change (-14.4+/-20.3) from baseline (82.1+/-21.3; P<.001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATX at every time point throughout the study (P values </=.012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates of insomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment-emergent adverse events were similar between groups. ATX monotherapy effectively improved symptoms of ADHD and comorbid social anxiety disorder in adults and was well tolerated.

Examination of the known-groups validity of the Liebowitz Social Anxiety Scale

We examined the known-groups validity of the Liebowitz Social Anxiety Scale (LSAS) by comparing the scores of patients with social anxiety disorder (n=46), generalized anxiety disorder plus an additional diagnosis of social anxiety disorder (n=15), generalized anxiety disorder without social anxiety disorder (n=12), and nonanxious controls (n=34). The LSAS total score discriminated significantly among all pairs of groups. Similar analyses were conducted on the original LSAS subscales and additional subscales derived from the factor-analytic work of Safren et al. [1999]. Original subscales showed a pattern substantially similar to that of the total score, but subscale intercorrelations and total score-subscale correlations were extremely high, suggesting that these subscales do not provide much unique information beyond that provided by the total score. Factor-analytically derived subscales were less highly correlated with each other or with the LSAS total score. Although the pattern of differences was more variable across subscales, the factor-analytically derived subscales, in conjunction with the total score, may provide more nonredundant information of clinical relevance than the original subscales. Limitations and future directions for research on the LSAS are discussed.

0089 ALCOHOL AND CANNABIS USE IN URBAN, AFRICAN AMERICAN, FIRST-EPISODE PSYCHOSIS PATIENTS: ASSOCIATIONS WITH POSITIVE AND NEGATIVE SYMPTOMS

Escitalopram is the most selective of the serotonin reuptake inhibitor (SSRI) antidepressants. We conducted a meta-analysis of placebo-controlled studies where escitalopram was used to treat patients with social anxiety disorder (SAD). Data from all randomised, double-blind placebo-controlled studies in SAD with escitalopram from both specialist settings and general practice were used. Patients met the DSM-IV criteria for SAD, were ≥18 years old, and had a Liebowitz Social Anxiety Scale (LSAS) ≥60. The primary outcome measure was the estimated treatment difference in LSAS total score at Week 12. Secondary outcome measures included the estimated treatment difference in the Clinical Global Impression-Severity (CGI-S) score at Week 12. A total of 1598 patients from 3 randomised controlled trials were included in the analyses. Escitalopram (n=1061) was superior to placebo (n=537), with an estimated treatment difference on the LSAS of −9.2 points (95%CI: [−14.4; −4.0], p<0.01) (escitalopram 5 mg/day), −4.6 points (95%CI: [−8.1; −1.0], p<0.01) (escitalopram 10 mg/day), −10.1 points (95%CI: [−13.7; −6.5], p<0.01) (escitalopram 20 mg/day) and −7.3 points (95%CI: [−12.3; −2.2], p<0.01) (escitalopram 10-20 mg/day). For the CGI-S, the corresponding values were −0.55 points (95%CI: [−0.79; −0.31], p<0.01) (escitalopram 5 mg/day), −0.26 points (95%CI: [−0.42; −0.10], p<0.01) (escitalopram 10 mg/day), −0.48 points (95%CI: [−0.64; −0.31], p<0.01) (escitalopram 20 mg/day) and −0.29 points (95%CI: [−0.51; −0.07], p<0.05) (escitalopram 10-20 mg/day). The withdrawal rate due to adverse events was 7.2% for escitalopram, compared with 4.3% for placebo (p<0.05). In this meta-analysis, all doses of escitalopram showed significant superiority in efficacy versus placebo in the treatment of patients with SAD.

An open trial of paroxetine for the “offensive subtype” oftaijin kyofusho and social anxiety disorder

The taijin kyofusho (TKS) offensive subtype is thought to be a culture-bound syndrome similar to social anxiety disorder (SAD). In Western countries, such patients would be diagnosed as having delusional disorder, somatic subtype, or body dysmorphic disorder. Recently, open trials for the TKS offensive subtype and a randomized controlled trial for body dysmorphic disorder demonstrated that selective serotonin reuptake inhibitors (SSRIs) might be as effective in TKS as in SAD. This study investigated the efficacy of the SSRI paroxetine in patients with the TKS offensive subtype, both on anxiety and fears, as well as insight. This study was a 12-week open trial using paroxetine in 22 patients with TKS. Subjects were diagnosed based on the original diagnostic criteria for the TKS offensive subtype. Insight regarding TKS symptoms was assessed by the 11th supplement subscale "Insight into obsessions and compulsions" of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Liebowitz Social Anxiety Scale (LSAS), the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), Rosenberg's Self-Esteem Scale, and the Interpersonal Distrust subscale of the Eating Disorder Inventory were also administered. Offensive anxiety was assessed by the original TKS offensive anxiety subscale (0-3 points). The primary efficacy variable was the Clinical Global Impression scale (CGI) global improvement item. Nineteen patients completed the study. Forty-seven percent (9/19) were responders to the drug treatment (scoring 2 or less on the CGI). Last observation carried forward (LOCF) analysis (N=22) demonstrated a statistically significant reduction in LSAS total score and offensive anxiety in TKS, and the insight scale score of the Y-BOCS also significantly improved. Interpersonal distrust showed a trend toward improvement.

A 24-Week Randomized, Double-Blind, Placebo-Controlled Study of Escitalopram for the Prevention of Generalized Social Anxiety Disorder

Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder (SAD). The present relapse prevention study investigated relapse rates during a 24-week, randomized, double-blind, placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram. A total of 517 patients with a primary diagnosis of generalized SAD (per DSM-IV criteria) and a Liebowitz Social Anxiety Scale (LSAS) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses (10-20 mg/day) of escitalopram. Of these patients, 371 responded (Clinical Global Impressions-Improvement scale [CGI-I] score of 1 or 2) and were randomly assigned to 24 weeks of double-blind treatment with escitalo-pram (10 or 20 mg/day) (N = 190) or placebo (N = 181), continuing with the dose level administered at the end of the open-label period. Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy, as judged by the investigator. The study was conducted from January 2001 to June 2002. Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo (log-rank test: p < .001). The risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients (p < .001), resulting in significantly fewer escitalopram-treated patients relapsing (22% vs. 50%), at both doses. Escitalopram was well tolerated during double-blind treatment of generalized SAD, and only 2.6% of the escitalopram-treated patients withdrew because of adverse events. The overall discontinuation rate, excluding relapses, was 13.2% for patients treated with escitalopram and 8.3% for patients treated with placebo. Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD.

Escitalopram in the treatment of social anxiety disorder

Selective serotonin reuptake inhibitors are effective in the treatment of social anxiety disorder and are currently regarded as the pharmacotherapy of choice. To investigate the efficacy and tolerability of escitalopram in the treatment of generalised social anxiety disorder. Patients with generalised social anxiety disorder were randomised to receive placebo (n=177) or 10-20 mg escitalopram (n=181) in a 12-week, double-blind trial. The primary outcome measure was the mean change from baseline to last assessment in the Liebowitz Social Anxiety Scale (LSAS) total score. The study showed a statistically superior therapeutic effect for escitalopram compared with placebo on the LSAS total score (P=0.005). There were significantly more responders to treatment for escitalopram than for placebo (54% v. 39%; P<0.01). The clinical relevance of these findings was supported by significant reduction in the work and social components of the Sheehan Disability Scale and by the good tolerability of escitalopram treatment. Escitalopram was efficacious and well tolerated in the treatment of generalised social anxiety disorder.