Tags

Type your tag names separated by a space and hit enter

Tiagabine in adult patients with generalized anxiety disorder: results from 3 randomized, double-blind, placebo-controlled, parallel-group studies.
J Clin Psychopharmacol 2008; 28(3):308-16JC

Abstract

The objective of these studies was to evaluate the efficacy and tolerability of tiagabine, a selective gamma-aminobutyric acid reuptake inhibitor, in adult patients with generalized anxiety disorder (GAD). Patients with a diagnosis of GAD were enrolled in 1 of 3 randomized, placebo-controlled, 10-week studies. In each study, tiagabine was taken twice daily in divided doses--4, 8, or 12 mg/d in a fixed-dose study and 4-16 mg/d in two flexible-dose trials. The primary efficacy measure was the change from baseline in the 14-item Hamilton Rating Scale for Anxiety (HAM-A) total score at the final visit (last observation carried forward). Additional measures included change from baseline in the anxiety subscale of the Hospital Anxiety and Depression Scale, the Sheehan Disability Scale, and Clinical Global Impressions-Improvement scale. Tolerability was assessed via spontaneous reports as well as rating scales throughout the study period. In all 3 studies, there was no significant differentiation from placebo on the primary measure (change in HAM-A) for any tiagabine dose (P > 0.05). In the 2 flexible-dose studies, the tiagabine group showed improvements over time in the HAM-A that reached significance only in those patients who completed 10 weeks of treatment (study 2, P = 0.018; study 3, P = 0.036). The most common adverse events were dizziness, headache, nausea, fatigue, and somnolence. In conclusion, the results of these studies do not support the efficacy of tiagabine in adult patients with GAD.

Authors+Show Affiliations

Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, 185 Cambridge Street, Boston, MA 02114, USA. mpollack@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18480688

Citation

Pollack, Mark H., et al. "Tiagabine in Adult Patients With Generalized Anxiety Disorder: Results From 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Studies." Journal of Clinical Psychopharmacology, vol. 28, no. 3, 2008, pp. 308-16.
Pollack MH, Tiller J, Xie F, et al. Tiagabine in adult patients with generalized anxiety disorder: results from 3 randomized, double-blind, placebo-controlled, parallel-group studies. J Clin Psychopharmacol. 2008;28(3):308-16.
Pollack, M. H., Tiller, J., Xie, F., & Trivedi, M. H. (2008). Tiagabine in adult patients with generalized anxiety disorder: results from 3 randomized, double-blind, placebo-controlled, parallel-group studies. Journal of Clinical Psychopharmacology, 28(3), pp. 308-16. doi:10.1097/JCP.0b013e318172b45f.
Pollack MH, et al. Tiagabine in Adult Patients With Generalized Anxiety Disorder: Results From 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Studies. J Clin Psychopharmacol. 2008;28(3):308-16. PubMed PMID: 18480688.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tiagabine in adult patients with generalized anxiety disorder: results from 3 randomized, double-blind, placebo-controlled, parallel-group studies. AU - Pollack,Mark H, AU - Tiller,Jane, AU - Xie,Fang, AU - Trivedi,Madhukar H, PY - 2008/5/16/pubmed PY - 2008/9/13/medline PY - 2008/5/16/entrez SP - 308 EP - 16 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 28 IS - 3 N2 - The objective of these studies was to evaluate the efficacy and tolerability of tiagabine, a selective gamma-aminobutyric acid reuptake inhibitor, in adult patients with generalized anxiety disorder (GAD). Patients with a diagnosis of GAD were enrolled in 1 of 3 randomized, placebo-controlled, 10-week studies. In each study, tiagabine was taken twice daily in divided doses--4, 8, or 12 mg/d in a fixed-dose study and 4-16 mg/d in two flexible-dose trials. The primary efficacy measure was the change from baseline in the 14-item Hamilton Rating Scale for Anxiety (HAM-A) total score at the final visit (last observation carried forward). Additional measures included change from baseline in the anxiety subscale of the Hospital Anxiety and Depression Scale, the Sheehan Disability Scale, and Clinical Global Impressions-Improvement scale. Tolerability was assessed via spontaneous reports as well as rating scales throughout the study period. In all 3 studies, there was no significant differentiation from placebo on the primary measure (change in HAM-A) for any tiagabine dose (P > 0.05). In the 2 flexible-dose studies, the tiagabine group showed improvements over time in the HAM-A that reached significance only in those patients who completed 10 weeks of treatment (study 2, P = 0.018; study 3, P = 0.036). The most common adverse events were dizziness, headache, nausea, fatigue, and somnolence. In conclusion, the results of these studies do not support the efficacy of tiagabine in adult patients with GAD. SN - 0271-0749 UR - https://www.unboundmedicine.com/medline/citation/18480688/Tiagabine_in_adult_patients_with_generalized_anxiety_disorder:_results_from_3_randomized_double_blind_placebo_controlled_parallel_group_studies_ L2 - http://Insights.ovid.com/pubmed?pmid=18480688 DB - PRIME DP - Unbound Medicine ER -