Assessment of Withania somnifera root extract efficacy in patients with generalized anxiety disorder: A randomized double-blind placebo-controlled trial

2020 ◽  
Vol 15 ◽  
Author(s):  
Sara Fuladi ◽  
Seyed Ahmad Emami ◽  
Amir Hooshang Mohammadpour ◽  
Asieh Karimani ◽  
Ali Akhondpour Manteghi ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Treatment Group ◽  
Generalized Anxiety Disorder ◽  
Withania Somnifera ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Root Extract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: Anxiety disorders are the most universal psychiatric problems in the general population. Due to their chronic nature, these diseases are managed with a multi-drug regimen lasting for a long period of time. Medication discontinuation leads to 25% and 80% recurrence in the first month and the first year, respectively. Despite several treatment approaches, there is no specific and optimal method for patient management. Therefore, it is necessary to find some new theraputic approaches with fewer side effects. Withania somnifera is a plant with GABAergic property responsible for its anxiolytic effect. The aim of this study was to investigate the effect of W. somnifera root extract as an alternative therapy to reduce standard generalized anxiety disorder (GAD) symptoms. Methods: Forty patients who met the inclusion criteria (with a confirmed diagnosis of GAD as stated in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) took part in this randomized double-blind placebo-controlled trial and were randomly selected for participation in the treatment group (W. somnifera extract, 1g/day; n = 22) or the placebo group (n = 18). All patients were under treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) and were prescribed one capsule of the extract or placebo per day for six weeks. The Hamilton anxiety rating scale (HAM-A) was used to assess the severity of GAD symptoms at baseline as well as the second and sixth weeks of the trial. Results: Comparison of the HAM-A scores during the course of the trial revealed a significant amelioration ofHAM-A score in the treatment group versus placebo (14 and 8 units reduction, respectively (P < 0.05)). Moreover, there was a significant difference in the reduction of GAD score between the second (P =0.04) and sixth week (P =0.02) in the treatment group. The extract was safe and no adverse effect was observed during the trial. Conclusion: W. somnifera extract offers some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD.

Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial

2011 ◽  
Vol 26 (4) ◽  
pp. 461-470 ◽  
Author(s):  
Sallie J Hadley ◽  
Francine S Mandel ◽  
Edward Schweizer
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hamilton Anxiety Rating Scale

To evaluate the efficacy of pregabalin in facilitating taper off chronic benzodiazepines, outpatients ( N = 106) with a lifetime diagnosis of generalized anxiety disorder (current diagnosis could be subthreshold) who had been treated with a benzodiazepine for 8–52 weeks were stabilized for 2–4 weeks on alprazolam in the range of 1–4 mg/day. Patients were then randomized to 12 weeks of double-blind treatment with either pregabalin 300–600 mg/day or placebo while undergoing a gradual benzodiazepine taper at a rate of 25% per week, followed by a 6-week benzodiazepine-free phase during which they continued double-blind study treatment. Outcome measures included ability to remain benzodiazepine-free (primary) as well as changes in Hamilton Anxiety Rating Scale (HAM)-A and Physician Withdrawal Checklist (PWC). At endpoint, a non-significant higher proportion of patients remained benzodiazepine-free receiving pregabalin compared with placebo (51.4% vs 37.0%). Treatment with pregabalin was associated with significantly greater endpoint reduction in the HAM-A total score versus placebo (−2.5 vs +1.3; p < 0.001), and lower endpoint mean PWC scores (6.5 vs 10.3; p = 0.012). Thirty patients (53%) in the pregabalin group and 19 patients (37%) in the placebo group completed the study, reducing the power to detect a significant difference on the primary outcome. The results on the anxiety and withdrawal severity measures suggest that switching to pregabalin may be a safe and effective method for discontinuing long-term benzodiazepine therapy.

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

2018 ◽  
Vol 52 (04) ◽  
pp. 193-202
Author(s):  
Konstantinos N. Fountoulakis ◽  
Vangelis Karavelas ◽  
Stefania Moysidou ◽  
Dimitris Mavridis ◽  
Konstantinos Pastiadis ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Major Depression ◽  
Generalized Anxiety Disorder ◽  
Controlled Study ◽  
Generalized Anxiety ◽  
Double Blind ◽  
Code Number ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Unipolar Major Depression

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).

scholarly journals Duloxetine treatment for relapse prevention in adults with generalized anxiety disorder: A double-blind placebo-controlled trial

2008 ◽  
Vol 18 (9) ◽  
pp. 673-681 ◽  
Author(s):  
Jonathan R.T. Davidson ◽  
Hans-Ulrich Wittchen ◽  
Pierre-Michel Llorca ◽  
Janelle Erickson ◽  
Michael Detke ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Double Blind ◽  
Double Blind Placebo
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