Comparative effects of pregabalin on anxiety and sleep disturbance: Results of a path analysis

2011 ◽  
Vol 26 (S2) ◽  
pp. 184-184
Author(s):  
H.-U. Wittchen ◽  
R. Prieto ◽  
B. Emir ◽  
S. Donevan

IntroductionSleep disturbance is one of the key DSM-IV criteria for generalized anxiety disorder (GAD), and represents the chief complaint in approximately one-third of patients presenting in the primary care setting.Objectives/aimsTo evaluate the extent to which improvement in anxiety is a direct effect of treatment with pregabalin, or is an indirect effect mediated by improvement in sleep disturbance, and vice-versa.MethodsData were pooled from 4 double-blind, placebo-controlled (n = 406) short-term trials of pregabalin (all doses combined; n = 853) in the treatment of generalized anxiety disorder (GAD). The effect of treatment on anxiety was measured using the Hamilton Anxiety Rating Scale (HAM-A), effect of treatment on sleep disturbance was measured using the 3-item Hamilton Depression Rating Scale (HAM-D) sleep factor. Path analyses, using a set of multivariate regression models, were used to evaluate the reciprocal effects of pregabalin on improvement in anxiety in the presence of improvement in sleep disturbance, and vice-versa.ResultsSleep disturbance was common in this GAD sample, with 51.2% (placebo) and 52.2% (pregabalin) of patients, respectively, reporting moderate-to-severe insomnia (HAM-D sleep factor score ≥3). The results of the path analysis indicated that 91.7% (P < 0.0001) of improvement in anxiety was a direct effect of treatment with pregabalin, while 8.3% of improvement in anxiety was an indirect effect, mediated by improvement in sleep disturbance.ConclusionsIn this pooled 4-study data set, the anxiolytic efficacy of pregabalin appears to be primarily a direct effect, with only a small (8.3%) indirect effect, mediated by improvement in sleep disturbance.

2019 ◽  
Vol 50 (6) ◽  
pp. 1063-1074
Author(s):  
Juan Martín Gómez Penedo ◽  
Michael J. Constantino ◽  
Alice E. Coyne ◽  
Felicia M. Romano ◽  
Henny A. Westra ◽  
...  

2020 ◽  
Author(s):  
Seung‐Hoon Lee ◽  
Cheolmin Shin ◽  
Hyounwook Kim ◽  
Sang Won Jeon ◽  
Ho‐Kyoung Yoon ◽  
...  

2011 ◽  
Vol 26 (4) ◽  
pp. 461-470 ◽  
Author(s):  
Sallie J Hadley ◽  
Francine S Mandel ◽  
Edward Schweizer

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.


2000 ◽  
Vol 34 (2) ◽  
pp. 147-153 ◽  
Author(s):  
Anna Fresquet ◽  
Mariano Sust ◽  
Antonio Lloret ◽  
Michael F Murphy ◽  
Frederick J Carter ◽  
...  

OBJECTIVE: To compare the relative efficacy and safety of lesopitron 40–80 mg/d versus lorazepam 2–4 mg/d and placebo in a subgroup of patients with anxiety history taken from a larger study of patients with a primary diagnosis of generalized anxiety disorder (GAD). DESIGN: Six-week, randomized, double-blind, parallel, placebo and lorazepam-controlled, Phase II, single-center, outpatient study. SETTING: Outpatient clinic. PATIENTS: One hundred sixty-one patients with GAD were randomized in the main study; 68 with a documented history of GAD or anxiety disorder not otherwise specified were included in the subgroup. METHODS: After a one-week placebo lead-in, patients were randomized to receive placebo, lesopitron, or lorazepam twice daily for six weeks, followed by a one-week taper period. Efficacy was assessed using the Hamilton Rating Scale for Anxiety (HAM-A) and the Clinical Global Impressions scale. Safety was assessed through physical examinations, monitoring of vital signs, 12-lead electrocardiograms, laboratory analyses, and adverse event monitoring. RESULTS: An overall mean improvement in the HAM-A total score between baseline and end point for all three treatment groups was seen, with mean changes of 3.4 (95% CI 2.0 to 4.8), 6.1 (95% CI 4.1 to 8.1), and 6.1 (95% CI 4.6 to 7.6) for the placebo, lesopitron, and lorazepam groups, respectively (omnibus p = 0.044, uncorrected). Positive treatment effects were also observed in the subgroup population on several other measures and suggest that additional therapeutic trials may be warranted. Future trials could be stratified on the basis of referral status (symptomatic volunteer vs. clinical patient with preexisting illness) or previous exposure to anxiolytics, and use a fixed-dose rather than flexible-fixed-dose design. CONCLUSIONS: The subgroup analysis represents a comparison of treatment outcome in GAD patients presenting with a history of previous episodes of GAD or anxiety disorder not otherwise specified compared with those who were experiencing their first episode of GAD and reported no anxiety history. Although the overall study analysis was equivocal, for the approximately 40% of patients with recurrent anxiety disorder, beneficial effects for both lesopitron and lorazepam are suggested.


2021 ◽  
Author(s):  
Zhongxia Shen ◽  
Lijun Cui ◽  
Lie Ren ◽  
Mincai Qian ◽  
Yonggui Yuan ◽  
...  

Abstract Introduction: S100B is a neurotrophic factor regulates neuronal growth and plasticity via activating astrocytes and microglia through production of neuro-inflammatory molecules like interleukin (IL)-1β involved in many mental disorders, few studies have combined S100B and cytokines to explore their roles as neuro-inflammatory biomarkers in Generalized Anxiety Disorder (GAD). Methods: Serum S100B and cytokines (IL-1β , IL-2, IL-4 and IL-10) of 108 untreated GAD cases and 123 healthy controls were determined by enzyme linked-immuno-sorbent assay (ELISA) and then compared, while Hamilton Anxiety Rating Scale (HAMA) scores were measured to evaluate anxiety severity. Results: The serum S100B and IL-1β, IL-2 levels of GAD cases were lower than HC significantly (P<0.001), the IL-4 level of GAD were higher than HC (P<0.001), while IL-10 had no significant difference between two groups (P=0.215). The ROC area of S100B, IL-1β, IL-2 and IL-4 in diagnosis of GAD was (0.740 ± 0.032) , (0.900 ± 0.021) , (0.920 ± 0.018) and (0.696 ± 0.037) , all of them suggested a good predicting value (P < 0.001) , while the ROC area of IL-10 was (0.544 ± 0.038) (P = 0.251). The sensitivity of S-100B, IL-1β, IL-2 in diagnosis of GAD was 73.1%, 80.6%, 85.2%, while the specificity was 61.0%, 86.2%, 80.5%. The combination ROC area of S100B, IL-1β , IL-2 and IL-4 was (0.985 ± 0.006)(P < 0.001). Serum S100B was positively correlated with IL-2 and IL-4 (P <0.05)., while was negatively with HAMA scores (P <0.001). Conclusion: The serum S-100B, IL-1β, IL-2 levels of GAD were down-regulated while IL-4 was up-regulated, both IL-2 and IL-4 had a good diagnosis value in GAD separately while the combination of S100B and cytokines had a better diagnosis value which means the neuro-inflammation in GAD is a network regulated by many factors.


2018 ◽  
Vol 4 (3) ◽  
pp. 111-113
Author(s):  
Chandni. C. Pillai ◽  
◽  
James Chacko ◽  
Devipriya Soman ◽  
Mahesh C Kundagol ◽  
...  

Generalized Anxiety Disorder is a common and disabling disorder characterized by persistent worrying, anxiety symptoms and tension about a variety of everyday problems for a period of at least 6 months [1]. The symptoms of this disease shows resemblance with the Chittodwega (Excited state of mind) which is one among the Manovikara (disease of mind) explained by Acharya Charaka. The contemporary management of this disease employs anxiolytics to be used in long run which is not conducive to health. This a case of 57 year old gentleman who presented with persistent anxiety and inability to relax . Based on signs and symptoms he was diagnosed as a case of GAD according to the ICD 10 F41.1 criteria. Treatment planned was Nasya (nasal administration) and Abhyanga (massage) followed by Shamanaushadhis (internal medicines). Brahmi gritha (medicated ghee) is widely practised as Paana (internal administartion) but in this case we have used it for nasal administration as it is the easiest way of delivering the potency of a drug to brain. Assessment of the condition of the patient before and after the treatment was done using Hamilton’s Anxiety Rating Scale to evaluate efficacy of treatment. After the completion of schedule of one week of IP treatment and further 21 days of OP level administration of medicine, a significant reduction in score from 18 to 13 on Hamilton’s Anxiety Rating Scale and improvement in symptoms was observed.


2020 ◽  
Author(s):  
Ergul Belge Kurutas

Abstract Background Generalized anxiety disorder (GAD) is a prevalent psychiatric disorder. Diagnosis of GAD depends on subjective complaints of patients, thus the need for biological markers is constantly emerging. This study aimed, for the first time, to investigate diagnostic value of Erythropoietin (Epo) and its receptor (EpoR) levels in drug-naive patients with GAD. Methods This study included 45 newly diagnosed drug-naive patients with GAD, aged and gender-matched 30 healthy controls. Medical histories were obtained, and physical examinations and laboratory tests were conducted; the Hamilton Anxiety Rating Scale (HAM-A) was also used for all participants. Serum Epo and EpoR levels were measured by ELISA. Results HAM-A score was significantly higher in GAD patients versus the controls (p< 0.05). While the levels of Epo in patients with GAD were lower than the control patients, EpoR levels were increased in these patients (p<0.05). Epo/EpoR ratios were significantly lower in the patients with GAD than in the control subjects (p<0.05). A positive significant correlation was observed between the EpoR level and the HAM-A score (r= 0.755, p<0.001). However, there was a negative significant correlation between Epo levels and HAM-A score (r= -0.749, p<0.001). ROC analysis revealed both sensitivity and specificity of 100%, respectively, for the presence of anxiety when the serum Epo value was 7.64 ng/mL (the area under the curve was 1.000) and EpoR value was 0.97 ng/mL (the area under the curve was 1.000). Conclusion Our findings showed that Epo/EpoR ratio may be an important biomarker for GAD. Epo may be a good choice for GAD treatment.


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