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      GABA-Ergic Drugs: Exit Stage Left, Enter Stage Right

      , 1
      Journal of Psychopharmacology
      SAGE Publications

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          Abstract

          Drugs that enhance gamma-aminobutyric acid (GABA) activity by interacting at post-synaptic GABA(A) receptors have long been used as hypnotics, sedatives, tranquillizers and anticonvulsants. In this category, benzodiazepines rapidly gained pride of place, replacing barbiturates and becoming the most commonly prescribed of all drugs in the Western world in the 1970s. However, problems such as dependence and withdrawal reactions became apparent in the 1980s, and it seemed that the usefulness of drugs with this mode of action was limited. Recently, focus has shifted to a new group of drugs with GABA-ergic actions mediated through various mechanisms not directly involving the GABA(A) receptor. These drugs include gabapentin, vigabatrin, tiagabine, lamotrigine, pregabalin and others. Although originally developed as anticonvulsants for epilepsy, they appear to have wider applications for use in affective disorders, especially bipolar depression, anxiety disorders and pain conditions. The current information on the properties and therapeutic potential of this new generation of GABA-ergic drugs is reviewed. It remains to be seen whether long-term use leads to tolerance, dependence and withdrawal or discontinuation reactions.

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          Most cited references40

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          A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders.

          There is a pressing need for additional treatment options for refractory mood disorders. This controlled comparative study evaluated the efficacy of lamotrigine (LTG) and gabapentin (GBP) monotherapy versus placebo (PLC). Thirty-one patients with refractory bipolar and unipolar mood disorders participated in a double-blind, randomized, crossover series of three 6-week monotherapy evaluations including LTG, GBP, and PLC. There was a standardized blinded titration to assess clinical efficacy or to determine the maximum tolerated daily dose (LTG 500 mg or GBP 4,800 mg). The primary outcome measure was the Clinical Global Impressions Scale (CGI) for Bipolar Illness as supplemented by other standard rating instruments. The mean doses at week 6 were 274 +/- 128 mg for LTG and 3,987 +/- 856 mg for GBP. Response rates (CGI ratings of much or very much improved) were the following: LTG, 52% (16/31); GBP, 26% (8/31); and PLC, 23% (7/31) (Cochran's Q = 6.952, df = 2, N = 31, p = 0.031). Post hoc Q differences (df = 1, N = 31) were the following: LTG versus GBP (Qdiff = 5.33, p = 0.011); LTG versus PLC (Qdiff = 4.76, p = 0.022); and GBP versus PLC (Qdiff = 0.08, p = 0.70). With respect to anticonvulsant dose and gender, there was no difference between the responders and the nonresponders. The agents were generally well tolerated. This controlled investigation preliminarily suggests the efficacy of LTG in treatment-refractory affectively ill patients. Further definition of responsive subtypes and the role of these medications in the treatment of mood disorders requires additional study.
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            Placebo-controlled study of gabapentin treatment of panic disorder.

            A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of panic disorder. One hundred three patients were randomly assigned to receive double-blind treatment with either gabapentin (dosed flexibly between 600 and 3,600 mg/day) or placebo for 8 weeks. No overall drug/placebo difference was observed in scores on the Panic and Agoraphobia Scale (PAS) (p = 0.606). A post hoc analysis was used to evaluate the more severely ill patients as defined by the primary outcome measure (PAS score > or = 20). In this population, the gabapentin-treated patients showed significant improvement in the PAS change score (p = 0.04). In patients with a PAS score of 20 or greater, women showed a greater response than men regardless of treatment. Adverse events were consistent with the known side effect profile of gabapentin and included somnolence, headache, and dizziness. One patient experienced a serious adverse event during the study. No deaths were reported. The results of this study suggest that gabapentin may have anxiolytic effects in more severely ill patients with panic disorder.
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              Safety review of adult clinical trial experience with lamotrigine.

              To date approximately 4000 adults > 12 years of age have been treated with lamotrigine in Glaxo Wellcome sponsored clinical trials. Review of the data from these trials shows lamotrigine to be effective and well tolerated in both add-on and monotherapy treatment. Safety of lamotrigine was comparable to that of other anticonvulsants in add-on controlled clinical trials. In addition, fewer than half the number of patients in monotherapy studies who were taking lamotrigine discontinued treatment because of adverse events compared to those taking carbamazepine and phenytoin. Most of the reported adverse events seen in lamotrigine treated patients in all studies were judged by the investigator to be mild or moderate in severity; few of the adverse events resulted in the withdrawal of patients from studies. Analysis of vital signs and clinical laboratory data have revealed no undesirable effect of lamotrigine on major systems of the body. The most concerning adverse event has been rash. In clinical trials, this has most often been limited to a simple morbilliform rash which is not associated with evidence of systemic involvement. The incidence of Stevens-Johnson syndrome (SJS) in clinical trials is approximately 1 in 1000. Rash associated with lamotrigine has typically occurred within the first 8 weeks of treatment. Data from clinical trials clearly point to exceeding currently recommended dosage guidelines of lamotrigine and co-administration of valproic acid (valproate sodium) as risk factors for rash. Early in 1997, Glaxo Wellcome strengthened existing warnings in the product label regarding the risk of rash and reinforced the importance of adherence to administration guidelines in an effort to reduce the incidence of rash.
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                Author and article information

                Journal
                Journal of Psychopharmacology
                J Psychopharmacol
                SAGE Publications
                0269-8811
                1461-7285
                July 02 2016
                June 2003
                July 02 2016
                June 2003
                : 17
                : 2
                : 174-178
                Affiliations
                [1 ]Department of Psychiatry, University of Newcastle upon Tyne, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
                Article
                10.1177/0269881103017002004
                12870563
                461eb542-6e36-49f8-9843-063d984e8e73
                © 2003

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