The Selective GABA Reuptake Inhibitor Tiagabine for the Treatment of Generalized Anxiety Disorder

Abstract

To evaluate the efficacy and tolerability of tiagabine, a selective γ-aminobutyric acid (GABA) reuptake inhibitor, in adults with generalized anxiety disorder (GAD). Method: This 8-week, randomized, doubleblind, multicenter, placebo-controlled study enrolled patients with GAD (DSM-IV). Tiagabine was initiated at 4 mg/day and then flexibly dosed twice a day to a maximum dose of 16 mg/day. Study drug was tapered after week 8 in decrements of 2 mg every other day. Efficacy assessments included the Hamilton Rating Scale for Anxiety (HAM-A) and Sheehan Disability Scale. Adverse events, sexual functioning, and change in depressive symptoms were monitored. Data were collected from May 2003 to January 2004. Results: A total of 266 patients (tiagabine, N = 134; placebo, N = 132) were included in safety analyses; 260 patients (tiagabine N = 130; placebo N = 130) were included in efficacy analyses. Tiagabine reduced symptoms of GAD according to the observed case and mixed models repeated-measures (MMRM) analyses but not the primary last-observation-carried-forward (LOCF) analysis. At final visit, the reduction from baseline in mean HAM-A total score was 11.8 for tiagabine, compared with 10.2 for placebo (LOCF analysis, p = .27). In a post hoc MMRM analysis, a significant difference in the mean reduction in HAM-A total score over the efficacy evaluation period was found, favoring tiagabine over placebo (p < .01). Tiagabine had an early onset of effect, as shown by significant reduction from baseline in mean HAM-A total score compared with placebo at week 1 (observed cases, p < .05). Tiagabine was generally well tolerated and not associated with changes in sexual functioning or depressive status. Symptoms of a discontinuation syndrome during taper were not observed. Conclusion: The primary LOCF analysis was negative; however, results from the observed case and MMRM analyses suggest that tiagabine may be a useful treatment option for adult patients diagnosed with GAD. These findings warrant further evaluation in randomized clinical studies.

Quality of Life and Treatment Outcome in Panic Disorder: Cognitive Behavior Group Therapy Effects in Patients Refractory to Medication Treatment

“…Other studies suggest marked impairment relative to other anxiety disorders, but at levels that may be less than major depression [2]. Randomized clinical trials comparing the efficacy of different treatment modalities of PD have demonstrated that, in addition to symptomatic improvement, treated patients with PD report significant improvements in their QoL [5,6,7,8,9]. However, few studies have assessed individual dimensions of QoL (e.g., physical, social, general functioning, mental health and general health perception) [2, 5].…”

For publication: Tiagabine in the discontinuation of long‐term benzodiazepine use

“…3 However, we should mention the possible temporal delay of TGB -one week -to bring about its anxiolytic effects. 4 Although anecdotic and thus warranting replication in large and wellcontrolled studies, the findings of our case report suggest that TGB might be a promising new pharmacological agent in the treatment of BDZ dependence. OR 10 CONSECUTIVE years the suicide rate in Japan has stayed at around 25 per 100 000, which is the highest among the developed countries.…”

Η Γενικευμένη Αγχώδης Διαταραχή Στο Σχολείο Και Ο Ρόλος Του Εκπαιδευτικού Στην Αντιμετώπισή Της

“…Παρ' όλα αυτά, σύμφωνα με την έρευνα του Noyes και των συνεργατών του (1987), αλλά και με τον Torgesen (1986), ο περιβαλλοντικός παράγοντας συνδέεται με την εμφάνιση της διαταραχής (Βασιλάκη, 2008). Επίσης, σύμφωνα με το Harvard-Brown Anxiety Research Program, οι λιγότεροι από τους μισούς ασθενείς με ΓΑΔ αντιμετώπισαν μερικώς ή οριστικά τη διαταραχή και το 27% απ' αυτούς εμφάνισε και πάλι τη διαταραχή (Pollack, Roy-Byrne, Ameringen, Snyder, Brown, Ondrasik & Rickels, 2005).…”