This study characterized the durability of improvement in patients who responded early or late while receiving vagus nerve stimulation (VNS). In both a pilot and pivotal study, patients were identified who had at least a 50% reduction in symptom scores 3 months (early responders) or 12 months (late responders) after starting VNS. Probabilities were determined for maintenance of response at 12-month and 24-month time-points. Consistency of improvement throughout the 24-month study period was evaluated, testing for change in serial depression ratings. In the pilot study, 30.5%, 23.7% and 45.8% were early responders, later responders, and non-responders, respectively. These rates were 14.6%, 19.5%, and 65.9% in the pivotal trial. The potential confound of alterations in antidepressant treatment was examined in the pivotal trial. In the pilot study, 72.2% and 61.1% of early responders (n=18) were responders at 12 and 24 months, respectively; 78.8% of late responders (n=14) were responders at 24 months. In the pivotal trial, of early responders (n=30), 63.3% and 76.7% maintained response at 12 and 24 months, respectively; of late responders (n=40), 65.0% maintained response at 24 months. Early and late responders had fewer changes in medication than non-responders across the pivotal study period. In both studies, analyses of serial depression ratings showed stable improvement in early and late responders. These samples had exceptional levels of chronicity and treatment resistance. Yet patients who showed substantial clinical benefit maintained the improvement at remarkably high rates. This durability of benefit was not attributable to alterations in other treatments.
"Several single cases with positive effects of VNS have also been reported.42) Overall, these clinical studies show an increase in efficacy of VNS over time with the effect being sustained in most patients who respond.36,43) Further, another recent clinical study showed that VNS significantly lowered relative risk of suicidal ideation and reduced all-cause mortality and suicide rates by about half as compared to those for patients with just TAU.44) "
[Show abstract][Hide abstract] ABSTRACT: Treatment resistant depression (TRD) is a global health concern affecting a large proportion of depressed patients who then require novel therapeutic options. One such treatment option that has received some attention in the past several years is vagal nerve stimulation (VNS). The present review briefly describes the relevance of this treatment in the light of other existing pharmacological and non-pharmacological options. It then summarizes clinical findings with respect to the efficacy of VNS. The anatomical rationale for its efficacy and other potential mechanisms of its antidepressant effects as compared to those employed by classical antidepressant drugs are discussed. VNS has been approved in some countries and has been used for patients with TRD for quite some time. A newer, fast-acting, non-invasive pharmacological option called ketamine is currently in the limelight with reference to TRD. This drug is currently in the investigational phase but shows promise. The clinical and preclinical findings related to ketamine have also been summarized and compared with those for VNS. The role of neurotrophin factors, specifically brain derived neurotrophic factor and its receptor, in the beneficial effects of both VNS and ketamine have been highlighted. It can be concluded that both these therapeutic modalities, while effective, need further research that can reveal specific targets for intervention by novel drugs and address concerns related to side-effects, especially those seen with ketamine.
Clinical Psychopharmacology and Neuroscience 08/2014; 12(2):83-93. DOI:10.9758/cpn.2014.12.2.83
"L'efficacité s'améliore progressivement avec le temps comme démontré par la seule étude randomisée contrôlée en double-aveugle D-02 : 17 % de rémission et 30 % de réponse à un an . La réponse thérapeutique est maintenue à deux ans chez 61 % des répondeurs « rapides » (trois mois de VNS) et chez 78,8 % des répondeurs « tardifs » (à 12 mois de VNS) . On ne constate pas de troubles cognitifs ni d'interaction pharmacologique. "
[Show abstract][Hide abstract] ABSTRACT: Resistance to psychopharmacological and psychotherapeutic therapies is a frequent difficulty clinicians are confronted to, with a frequency of 20 to 30 % concerning depression disorders. Other therapeutic approaches hence seem unavoidable to optimize treatments: structured psychotherapies such as behavioural and interpersonal therapies have shown their efficiency in anxiety and depression disorders, psychoeducational approaches help better observance in chronic pathologies. Biological and non medicinal approaches such as electroconvulsive therapy are still a therapy of reference for treating mood disorders and remain an indication for resisting schizophrenic disorders.
"Open-label series have found some evidence of beneficial effects in anxiety disorders (Greenberg et al. 2008). A trial of VNS, placed in the abdomen below the for up to 3 years in some cases (Sackeim et al. 2007). Novel effects of VNS have been seen in several animal models and may provide explanations for these slower but more durable clinical effects (Valdes-Cruz et al. 2008; Biggio et al. 2009; Manta et al. 2009). "
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