Tiagabine for the Treatment of Generalized Anxiety Disorder: A Randomized, Open-Label, Clinical Trial With Paroxetine as a Positive Control
J Clin Psychiatry 2003;64(10):1245-1249
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Gamma-aminobutyric acid (GABA) plays
a central role in the pathophysiology of anxiety. Tiagabine, a
selective GABA reuptake inhibitor, enhances normal GABA tone.
This 10-week, randomized, open-label trial evaluated tiagabine in
patients with generalized anxiety disorder (GAD), with paroxetine
serving as a positive control.
Method: Adult patients with DSM-IV GAD were
randomly assigned to receive either tiagabine or paroxetine.
Tiagabine was initiated at 4 mg/day (2 mg morning and evening)
during week 1. Between weeks 2 and 6, the dose was individually
titrated in 2-mg increments (maximum increase of 4 mg/week) for
optimal response to a maximum dose of 16 mg/day (8 mg morning and
evening). During weeks 7 through 10, patients received the dosage
determined during the titration period. Paroxetine was initiated
at 20 mg nightly for the first week and similarly titrated in
10-mg increments to a maximum dose of 60 mg/day. Assessments
included the Hamilton Rating Scale for Anxiety (HAM-A), Hospital
Anxiety and Depression Scale (HADS), Hamilton Rating Scale for
Depression (HAM-D), Pittsburgh Sleep Quality Index (PSQI), and
Sheehan Disability Scale (SDS).
Results: Forty patients were enrolled
(tiagabine, N = 20; paroxetine, N = 20). Mean final doses were
tiagabine 10 mg/day (range, 4-16 mg/day) or paroxetine 27 mg/day
(range, 20-40 mg/day). Tiagabine and paroxetine significantly
reduced anxiety (HAM-A and HADS total and anxiety subscales).
Although patients were not diagnosed with a mood disorder, both
tiagabine and paroxetine reduced comorbid depressive symptoms
(HAM-D total and HADS total and depressive subscale). Tiagabine
and paroxetine significantly improved sleep quality (PSQI) and
functioning (SDS). Both tiagabine and paroxetine were well
Conclusion: The selective GABA reuptake
inhibitor tiagabine and the positive control paroxetine
significantly reduced anxiety and comorbid depressive symptoms,
improved sleep quality and functioning, and were well tolerated
in patients with GAD. Tiagabine may be a therapeutic option for
the treatment of anxiety disorders.