Venlafaxine Extended Release vs Placebo and Paroxetine in Social Anxiety Disorder

New York State Psychiatric Institute, New York 10032, USA.
Archives of General Psychiatry (Impact Factor: 14.48). 02/2005; 62(2):190-8. DOI: 10.1001/archpsyc.62.2.190
Source: PubMed


Evidence indicates that venlafaxine hydrochloride extended release (ER) effectively ameliorates anxiety symptoms.
To evaluate the efficacy, safety, and tolerability of flexible-dose venlafaxine ER compared with placebo in the short-term treatment of generalized social anxiety disorder and, secondarily, to compare paroxetine with venlafaxine ER and paroxetine with placebo.
Adult outpatients with DSM-IV generalized social anxiety disorder for 6 months or longer were randomly assigned to receive venlafaxine hydrochloride ER (75-225 mg/d), paroxetine (20-50 mg/d), or placebo for 12 weeks or less at 26 centers in the United States. The primary outcome measure was the total Liebowitz Social Anxiety Scale score. Secondary measures included response (Clinical Global Impression-Improvement score, 1 or 2) rates and Clinical Global Impression-Severity of Illness and Social Phobia Inventory scores.
Of 440 patients treated, 413 (93.9%) were included in the last-observation-carried-forward efficacy analysis; of the 429 patients in the safety population, 318 (74.1%) completed the study. Mean daily doses were 201.7 mg (SD, 38.1 mg) of venlafaxine hydrochloride ER and 46.0 mg (SD, 7.9 mg) of paroxetine. Venlafaxine ER treatment was significantly superior to placebo at weeks 1 through 12 on the Liebowitz Social Anxiety Scale and Social Phobia Inventory and at week 2 and weeks 6 through 12 for Clinical Global Impression-Severity of Illness and responder status, and was significantly superior to paroxetine treatment at weeks 1 and 2 for the Social Phobia Inventory (P < .05 for all). Paroxetine treatment was significantly superior to placebo at weeks 3 through 12 on the Liebowitz Social Anxiety Scale, the Clinical Global Impression-Severity of Illness scale, and the Social Phobia Inventory, and at weeks 4 through 12 for response (P < .05 for all). Week 12 response rates were significantly greater for the venlafaxine ER and paroxetine groups (58.6% and 62.5%, respectively) vs the placebo group (36.1%) (P < .001 for both).
Venlafaxine ER is effective in the short-term treatment of generalized social anxiety disorder, with efficacy and tolerability comparable to paroxetine.

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    • "While no clear evidence has shown that the combination of SSRIs and CBT is more effective than single-modality treatment [10,11], CBT has a number of potential advantages over pharmacotherapy in the treatment of anxiety disorder: longer effects, fewer adverse effects, smaller relapse rates, and greater acceptability [12-14]. Pharmacotherapy has disadvantages such as more side effects and higher rates of relapse with the discontinuation of medication [15,16]. "
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    ABSTRACT: Cognitive behavior therapy (CBT) is regarded as an effective treatment for social anxiety disorder (SAD) in Europe and North America. Individual CBT might be acceptable and effective for patients with SAD even in non-Western cultures; therefore, we conducted a feasibility study of individual CBT for SAD in Japanese clinical settings. We also examined the baseline predictors of outcomes associated with receiving CBT. This single-arm trial employed a 14-week individual CBT intervention. The primary outcome was the self-rated Liebowitz Social Anxiety Scale, with secondary measurements of other social anxiety and depressive severity. Assessments were conducted at baseline, after a waiting period before CBT, during CBT, and after CBT. Of the 19 subjects screened, 15 were eligible for the study and completed the outcome measures at all assessment points. Receiving CBT led to significant improvements in primary and secondary SAD severity (ps < .001). The mean total score on the Liebowitz Social Anxiety Scale improved from 91.8 to 51.7 (before CBT to after CBT), and the within-group effect size at the end-point assessment was large (Cohen’s d = 1.71). After CBT, 73% of participants were judged to be treatment responders, and 40% met the criteria for remission. We found no significant baseline predictors of those outcomes. Despite several limitations, our treatment—which comprises a 14-week, individual CBT program—seems feasible and may achieve favorable treatment outcomes for SAD in Japanese clinical settings. Further controlled trials are required in order to address the limitations of this study. Trial registration UMIN-CTR UMIN000005897
    Full-text · Article · Feb 2013 · BMC Research Notes
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    • "Venlafaxine is the only serotonin-norepinephrine reuptake inhibitor (SNRI) studied in RCT in patients with social phobia, but improvements in social phobia symptom ratings have also been shown in an open-label trial of the SNRI, duloxetine.45 All five reported studies23,28,46–48 have shown significantly greater response rates for venlafaxine compared with placebo (Figure 2, OR range for treatment response 1.89–3.78). Four of five studies used flexible dosing, with mean daily doses of approximately 200 mg/day. "
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    ABSTRACT: This article proposes a number of recommendations for the treatment of generalized social phobia, based on a systematic literature review and meta-analysis. An optimal treatment regimen would include a combination of medication and psychotherapy, along with an assertive clinical management program. For medications, selective serotonin reuptake inhibitors and dual serotonin-norepinephrine reuptake inhibitors are first-line choices based on their efficacy and tolerability profiles. The nonselective monoamine oxidase inhibitor, phenelzine, may be more potent than these two drug classes, but because of its food and drug interaction liabilities, its use should be restricted to patients not responding to selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. There are other medication classes with demonstrated efficacy in social phobia (benzodiazepines, antipsychotics, alpha-2-delta ligands), but due to limited published clinical trial data and the potential for dependence and withdrawal issues with benzodiazepines, it is unclear how best to incorporate these drugs into treatment regimens. There are very few clinical trials on the use of combined medications. Cognitive behavior therapy appears to be more effective than other evidence-based psychological techniques, and its effects appear to be more enduring than those of pharmacotherapy. There is some evidence, albeit limited to certain drug classes, that the combination of medication and cognitive behavior therapy may be more effective than either strategy used alone. Generalized social phobia is a chronic disorder, and many patients will require long-term support and treatment.
    Preview · Article · May 2012 · Neuropsychiatric Disease and Treatment
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    • "Flexible doses of venlafaxine extended-release (75–225 mg/day) in the short term produced a significantly greater clinical improvement than placebo in managing phobic-related states, together with a good side effect profile. Most of the adverse events reported were mild to moderate in severity, and were similar to previous data from major depression and general anxiety disorder studies.65,66 The long-term efficacy and safety of venlafaxine extended-release at different dosages (75 mg/day and 150–225 mg/day) was assessed in a 6-month trial, showing comparable response and remission rates for both lower and higher doses.67 "
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    Full-text · Article · Sep 2011 · Neuropsychiatric Disease and Treatment
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