Social adjustment in generalised anxiety disorder: a long-term placebo-controlled study of venlafaxine extended release

2004 ◽  
Vol 19 (5) ◽  
pp. 272-279 ◽  
Author(s):  
Patrice Boyer ◽  
Vincent Mahé ◽  
David Hackett

AbstractThe objective of this analysis was to evaluate the short- (8 weeks) and long-term (24 weeks) efficacy of three fixed doses of venlafaxine extended release (ER) and placebo on the social adjustment of patients with generalised anxiety disorder (GAD). We analysed data from 544 outpatients who participated in a 24-week, double-blind, multicentre, parallel-group, placebo-controlled study conducted at 55 centres in five countries. All patients meet the DSM-IV criteria for GAD and were randomly assigned to receive venlafaxine ER 37.5, 75, and 150 mg or matched placebo administered orally once daily. Social adjustment was measured using the Social Adjustment Scale-Self Report, which explores social adaptation in the areas of work, social and leisure, extended family, primary relationship (marital), parental, and family unit. At baseline, the GAD patients had a high level of social dysfunction. Venlafaxine ER showed a dose-related improvement in social impairment during short-term treatment and in sustaining this improvement over the long-term. In the most severely socially impaired subgroup, placebo remission rates on the HAM-A were low, and the magnitude of the venlafaxine-placebo difference on the mean HAM-A total score was high, reaching more than 7 points. The benefits of venlafaxine ER treatment of GAD extend beyond that of improvement of anxiety symptoms to a significant improvement in the impairment of functioning that is associated with the illness.

2001 ◽  
Vol 179 (1) ◽  
pp. 15-22 ◽  
Author(s):  
Christer Allgulander ◽  
David Hackett ◽  
Eliseo Salinas

BackgroundGeneralised anxiety disorder (GAD) has received less study than other anxiety disorders, particularly its long-term treatment.AimsTo assess the efficacy and safety of venlafaxine extended release (ER) in patients with GAD.MethodA total of 541 out-patients, 18–86 years old, were recruited to this 24-week, placebo-controlled, double-blind study of three fixed doses (37.5, 75 and 150 mg/day) of venlafaxine ER.ResultsAll doses of venlafaxine ER showed efficacy superior to placebo, apparent from week 2, that was sustained throughout the 24-week study for the two higher doses. The discontinuation rate did not differ significantly among the treatment groups.ConclusionsVenlafaxine ER is an effective and safe treatment for GAD for up to 6 months.


2003 ◽  
Vol 18 (4) ◽  
pp. 182-187 ◽  
Author(s):  
David Hackett ◽  
Vincent Haudiquet ◽  
Eliseo Salinas

AbstractThis randomised, double-blind, placebo-controlled study compared the efficacy of venlafaxine XR (75 or 150 mg/d) with diazepam (15 mg/d) over an 8-week treatment period in 540 non-depressed outpatients with generalised anxiety disorder (GAD). At week 8, significant improvements from baseline were observed in the venlafaxine XR, diazepam and placebo groups. Although these improvements were higher in the first two groups than in the placebo group for each of the primary efficacy variables (Hamilton Rating Scale for Anxiety (HAM-A) total, HAM-A psychic anxiety factor, Hospital Anxiety and Depression Scale (HAD) anxiety sub-scale and Clinical Global Impression (CGI) improvement), there were no statistically significant differences between groups. These non-positive results were thought to be due to the very high placebo response observed in some centres. To understand the variability of the study, a secondary preplanned analysis was performed. This involved sub-dividing the study centres according to their ability to detect a two-point mean difference between diazepam and placebo at week 8 on the HAM-A total score. Centres able to show such a difference were termed verum-sensitive. Improvements from baseline to week 8 in venlafaxine XR-treated patients from verum-sensitive centres were significantly greater than in placebo on each of the primary efficacy measures (P ≤ 0.05). This suggests that those centres able to detect an anxiolytic effect of diazepam were also able to detect an anxiolytic effect of venlafaxine XR. Significant differences in baseline demographics, rates of adverse event reporting and rates of patient discontinuations were noted between patients enrolled at verum-sensitive and verum-insensitive sites. These results reflect the importance of study centre selection in accurately determining efficacy in placebo-controlled trials.


2017 ◽  
Vol 41 (S1) ◽  
pp. S722-S722
Author(s):  
C. Carmassi ◽  
P. Isabella ◽  
C.A. Bertelloni ◽  
M. Corsi ◽  
G. Massimetti ◽  
...  

IntroductionRescue emergency personnel is at high risk to develop PTSD due to possible extreme and repetitive exposition to “cruel details of traumatic events”.ObjectiveThis study aimed to explore posttraumatic stress and subthreshold autism symptomatology and their impact on social and working functioning level among sub mariner of Italian Navy, who were employed in the Costa Concordia and Genova tower rescue operation.MethodsEighty-five subjects were enrolled and investigated by the following instruments: Trauma and Loss Spectrum Self-Report (TALS-SR), Adult Autism Subthreshold Spectrum (AdAS Spectrum) and Work and Social Adjustment Scale (WSAS).ResultsThe response rate was about 50%. Ninety-five percent of the subjects were employed in recovering corpses and 80% reported at least one rescue operation in the last three years. Full and partial DSM-5 PTSD rates were 8% and 27.5%, respectively. A strong correlation emerged between several TALS-SR and ADAS domain. Furthermore, TALS-SR domain scores were related to WSAS domain.ConclusionThis data showed rescue personnel to be at risk for post-traumatic stress spectrum and related work and social impairment. Further studies are needed to better investigate possible risk and resilience factors associated to PTSD.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2013 ◽  
Vol 28 ◽  
pp. 1
Author(s):  
S. Kasper ◽  
C. Iglesias-García ◽  
E. Schweizer ◽  
J. Wilson ◽  
S. Dubrava ◽  
...  

2006 ◽  
Vol 120 (5) ◽  
pp. 381-384 ◽  
Author(s):  
S Robertson ◽  
S Loughran ◽  
K MacKenzie

Background: In the absence of surgical treatments with demonstrable long-term efficacy, conservative treatments for snoring remain appropriate. Only limited evidence evaluating the use of ear protection by partners has been published.Methods: Eligible couples were invited to participate in a two-month trial, with each partner using custom-moulded ear plugs. Five questionnaires were completed by patients and their partners, at baseline and after two months: the snoring outcomes survey (SOS) or the spouse/bed partners survey (SBPS), the Epworth sleepiness scale (ESS), the general health questionnaire-12 (GHQ-12), the Nottingham health profile (NHP) and the Golombok–Rust inventory of marital status (GRIMS).Results: After two months, there was a significant improvement in the SOS score for patients (p = 0.005), the SBPS score for partners (p = 0.001) and the ESS for partners (p = 0.004).Conclusions: For selected couples, ear plugs represent an effective short-term treatment for some of the social effects of disruptive snoring, as determined by the SOS, SBPS and ESS questionnaires.


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