Improvement of psychic and somatic symptoms in adult patients with generalized anxiety disorder: examination from a duloxetine, venlafaxine extended-release and placebo-controlled trial

Nicolini, Humberto; Bakish, David; Dueñas, Héctor; Spann, Melissa E.; Erickson, Janelle; Hallberg, Christoffer; Ball, Susan; Sagman, Doron; Russell, James M.

doi:10.1017/s0033291708003401

Cited by 58 publications

(60 citation statements)

References 22 publications

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“…The efficacy of duloxetine for the treatment of GAD has been demonstrated in five large, double-blind, randomized trials (Davidson et al, 2008;Hartford et al, 2007;Koponen et al, 2007;Nicolini et al, 2008;Rynn et al, 2008). Further, this agent has demonstrated efficacy in animal models of persistent pain and in clinical studies of pain associated with diabetic neuropathy Raskin et al, 2005;Wernicke et al, 2006), fibromyalgia (Arnold et al, 2004(Arnold et al, , 2005Russell, Mease et al, 2008), and depression (Goldstein et al, 2004).…”

Section: Discussionmentioning

confidence: 99%

“…In addition, duloxetine has been shown to reduce painful physical symptoms associated with depression (Goldstein et al, 2004). In more recent clinical studies, duloxetine was also found to effectively reduce somatic symptoms and pain severity in patients with GAD Nicolini et al, 2008;Russell, Weisberg et al, 2008). Because previous analyses were based on the subgroup of patients who had clinically significant pain levels (visual analogue scale [VAS] scores !30 at baseline) Russell, Weisberg et al, 2008), additional investigation of the effect of duloxetine on painful physical symptoms in GAD patients from the overall clinical trial population would be informative to describe the presence and course of painful physical symptoms in patients with GAD.…”

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confidence: 99%

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The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: Results from three clinical trials

Beesdo¹,

Hartford²,

Russell

et al. 2009

Journal of Anxiety Disorders

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Generalized anxiety disorder (GAD) is associated with painful physical symptoms (PPS). These post hoc analyses of previous trial data assessed PPS and their response to duloxetine treatment in GAD patients. Studies 1 and 2 (n=840) were 9- to 10-week efficacy trials; study 3 (n=887) was a relapse prevention trial comprising a 26-week open-label treatment phase and a 26-week double-blind, placebo-controlled treatment continuation phase. Mean baseline visual analog scale scores (VAS, 0-100; n=1727) ranged from 26 to 37 for overall pain, headache, back pain, shoulder pain, interference with daily activities, and time in pain while awake. In studies 1 and 2, improvement on all VAS scores was greater in duloxetine-treated than in placebo-treated patients (p

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: Results from three clinical trials

Beesdo¹,

Hartford²,

Russell

et al. 2009

Journal of Anxiety Disorders

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“…In comparator studies, it was more effective than placebo and as effective as pregabalin (Montgomery et al 2006b) and duloxetine (Hartford et al 2007;Nicolini et al 2008). In a further comparator study, it was more effective than buspirone (Davidson et al 1999); however, scores were only significantly lower for HAM-A psychic anxiety factor, anxious mood, and tension, but not for HAM-A total and CGI for venlafaxinetreated patients than for placebo-treated patients.…”

Section: Generalized Anxiety Disorder (Gad)mentioning

confidence: 95%

“…Á Duloxetine was more effective than placebo in DBPC studies (Koponen et al 2007;Rynn et al 2007aRynn et al , 2008. Also, in three-arm studies, both duloxetine and the comparator venlafaxine were better than placebo (Hartford et al 2007;Nicolini et al 2008). Two studies with a placebo and a venlafaxine arm were pooled in order to ensure adequate statistical power for a non-inferiority trial.…”

Section: Generalized Anxiety Disorder (Gad)mentioning

confidence: 99%

World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision

Bandelow

Zohar

Hollander

et al. 2008

The World Journal of Biological Psychiatry

718

410

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In this report, which is an update of a guideline published in 2002 (Bandelow et al. 2002, recommendations for the pharmacological treatment of anxiety disorder, obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) are presented. Since the publication of the first version of this guideline, a substantial number of new randomized controlled studies of anxiolytics have been published. In particular, more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs. The recommendations, developed by the World Federation of Societies of Biological Psychiatry (WFSBP) Task Force for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders, a consensus panel of 30 international experts, are now based on 510 published randomized, placebo-or comparator-controlled clinical studies (RCTs) and 130 open studies and case reports. First-line treatments for these disorders are selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs) and the calcium channel modulator pregabalin. Tricyclic antidepressants (TCAs) are equally effective for some disorders, but many are less well tolerated than the SSRIs/ SNRIs. In treatment-resistant cases, benzodiazepines may be used when the patient does not have a history of substance abuse disorders. Potential treatment options for patients unresponsive to standard treatments are described in this overview. Although these guidelines focus on medications, non-pharmacological were also considered. Cognitive behavioural therapy (CBT) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders, OCD, and PTSD to support them being recommended either alone or in combination with the above medicines.

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“…A further comparative study of duloxetine and venlafaxine was performed in 33 non-US sites (Nicolini et al 2008). Diagnostic criteria were substantially the same as those used in the previous trials with the HAM-A scale as the primary efficacy measure.…”

Section: Use Of Duloxetine In Generalized Anxiety Disordermentioning

confidence: 99%

Duloxetine in the treatment of generalized anxiety disorder

Norman

Olver²

2009

NDT

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Duloxetine, a medication with effects on both serotonin and noradrenaline transporter molecules, has recently been approved for the treatment of generalized anxiety disorder. The evidence for its effi cacy lies in a limited number of double blind, placebo controlled comparisons. Statistically signifi cant improvements in the Hamilton Anxiety Rating Scale from baseline were demonstrated in all studies at doses of 60 to 120 mg per day. The signifi cance of such changes in terms of clinical improvements compared to placebo is less certain, particularly when the effect size of the change is calculated. In comparative trials with venlafaxine, duloxetine was as effective in providing relief of anxiety symptoms. In addition to improvements in clinical symptoms duloxetine has also been associated with restitution of role function as measured by disability scales. Duloxetine use is associated with nausea, dizziness, dry mouth, constipation, insomnia, somnolence, hyperhidrosis, decreased libido and vomiting. These treatment emergent side effects were generally of mild to moderate severity and were tolerated over time. Using a tapered withdrawal schedule over two weeks in the clinical trials, duloxetine was associated with only a mild withdrawal syndrome in up to about 30% of patients compared to about 17% in placebo treated patients. Duloxetine in doses of up to 200 mg twice daily did not prolong the QTc interval in healthy volunteers. Like other agents with dual neurotransmitter actions duloxetine reduces the symptoms of generalized anxiety disorder in short term treatments. Further evidence for its effi cacy and safety in long term treatment is required.

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Improvement of psychic and somatic symptoms in adult patients with generalized anxiety disorder: examination from a duloxetine, venlafaxine extended-release and placebo-controlled trial

Abstract: Duloxetine and venlafaxine treatment were each efficacious for improvement of core psychic anxiety symptoms and associated somatic symptoms for adults with GAD.

Cited by 58 publications

References 22 publications

The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: Results from three clinical trials

The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: Results from three clinical trials

World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision

Duloxetine in the treatment of generalized anxiety disorder

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