Efficacy of Add-on Pregabalin in the Treatment of Patients with Generalized Anxiety Disorder and Unipolar Major Depression With an Early Nonresponse to Escitalopram: A Double-Blind Placebo-Controlled Study

Konstantinos N. Fountoulakis; Vangelis Karavelas; Stefania Moysidou; Dimitris Mavridis; Konstantinos Pastiadis; Nicole Petalidou; Ioannis Nimatoudis; Siegfried Kasper

doi:10.1055/a-0695-9223

Pharmacopsychiatry, Table of Contents

Pharmacopsychiatry 2019; 52(04): 193-202
DOI: 10.1055/a-0695-9223

Original Paper

Efficacy of Add-on Pregabalin in the Treatment of Patients with Generalized Anxiety Disorder and Unipolar Major Depression With an Early Nonresponse to Escitalopram: A Double-Blind Placebo-Controlled Study

Authors

Konstantinos N. Fountoulakis

¹3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Vangelis Karavelas

¹3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Stefania Moysidou

¹3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Dimitris Mavridis

²Department of Primary Education, School of Education, and Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina, Ioannina, Greece
Konstantinos Pastiadis

³Electrical and Computer Engineering, School of Music Studies, Aristotle University of Thessaloniki, Thessaloniki, Greece
Nicole Petalidou

¹3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Ioannis Nimatoudis

¹3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Siegfried Kasper

⁴Department of Psychiatry and Psychotherapy, Medical University Vienna, MUV, AKH, Vienna, Austria

Abstract

Introduction This study tests the efficacy of pregabalin versus placebo as adjunctive treatment in patients with generalized anxiety disorder (GAD) comorbid with unipolar major depression (UMD) and with an early nonresponse to escitalopram.

Methods This is a double-blind, placebo-controlled 8-week add-on study of pregabalin, 75–600 mg/day (n=31) versus placebo (n=29) on open-label escitalopram in outpatients meeting the DSM-IV-TR criteria for GAD and UMD. The main outcome measures were change from baseline to endpoint in total STAI-S, Trail-Making Test B (TMT-B) and the Center of Epidemiological Studies Depression Scale (CES-D). Also changes in the parameters of the pupil’s reaction to light stimuli.

Results There was no significant difference in any of the primary or secondary outcomes or response and remission rates concerning any analysis (last observation carried-forward of at least visit 2 or completers) between the 2 treatment arms. One additional finding of the current study is that adding pregabalin does not have a significant effect on autonomic function.

Discussion This study does not support the usefulness of adding pregabalin in patients with GAD and UMD and with an early nonresponse to escitalopram (EudraCT Number: 2012-004062-17, Sponsor’s Protocol Code Number: WS1702721).

Key words

add-on - pregabalin - generalized anxiety - depression - escitalopram

Full Text

References

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