Evaluation of the therapeutic efficacy and safety of the selective anxiolytic afobazole in generalized anxiety disorder and adjustment disorders: Results of a multicenter randomized comparative study of diazepam

2016 ◽  
Vol 88 (8) ◽  
pp. 73-86 ◽  
Author(s):  
T S Syunyakov ◽  
G G Neznamov
Keyword(s):  
Anxiety Disorder ◽  
Adverse Events ◽  
Generalized Anxiety Disorder ◽  
Withdrawal Syndrome ◽  
Rating Scale ◽  
Phase Iii ◽  
Generalized Anxiety ◽  
Adjustment Disorders ◽  
Diazepam Withdrawal ◽  
The Difference

Aim. To summarize the previously published results of a multicenter randomized clinical research phase III study trial of afobazole (INN: fabomotizole) versus diazepam in the treatment of patients with generalized anxiety disorder (GAD) and adjustment disorders (AD). Subjects and methods. Five investigating centers included 150 patients aged 18 to 60 years (60 patients with GAD and 90 with AD) a simple structure of anxiety disorders without concurrent mental, neurological or somatic disorders. Patients were randomized to take afobazole (30 mg/day; n=100) or diazepam (30 mg/day; n=50) for 30 days. Prior to drug administration, patients susceptible to placebo were excluded according to the results of its 7-day use. Withdrawal syndrome was evaluated within 10 days after completion of active therapy. The primary efficacy endpoint was the change of Hamilton Anxiety Rating Scale (HAMA) total score. The scores of the Clinical Global Impression (CGI) Scale and the Sheehan Scale as secondary efficacy endpoints  were analyzed. Drug safety was evaluated by assessment of adverse events. Results. Afobazole and diazepam caused a significant reduction of HAMA total score. In the afobazole group, the reduction of anxiety  exceeded that in the diazepam group (the difference in the total score changes was 2.93 [0.67; 5.19]; p=0,01).The proportion of patients with reduction of disease severity was 72% in the afobazole group and 58% in the diazepam group. After therapy completion, the proportion of patients with no or mild disorder in the afobazole group was significantly higher than that in the diazepam group (69 and 44%, respectively; χ2=12.46; p=0,014). There was a trend toward a higher subjective patient-rated estimate of the afobazole effect using the Sheehan scale. There were a total of 15 and 199 adverse events in the afobazole and diazepam groups, respectively. No manifestations of afobazole withdrawal syndrome were found. Diazepam withdrawal syndrome was observed in 34 (68%) patients. Conclusion. Afobazole is an effective and safe drug to treat patients with GAD and AD and non-inferior than diazepam in the treatment of these disorders, however it is superior in terms of several variables, including the safety profile.

scholarly journals Efficacy and Safety of a Formulated Herbal Granula, Jiu Wei Zhen Xin, for Generalized Anxiety Disorder: A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Sheng Wang ◽  
Lin-lin Zhao ◽  
Xin-jian Qiu ◽  
Dong-sheng Wang ◽  
Tao Tang ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Adverse Events ◽  
Generalized Anxiety Disorder ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Generalized Anxiety ◽  
Efficacy And Safety ◽  
Significant Difference

Background. The traditional Chinese medicine formula Jiu Wei Zhen Xin Granula (JWZXG) is prescribed to treat generalized anxiety disorder (GAD) in China. This study was to assess the efficacy and safety of JWZXG in patients with GAD. Method. Data were pooled from 14 randomized controlled trials involving the assessment of mean changes of Hamilton Anxiety Rating Scale (HAMA) total scores, response rates, adverse event rates, quality, publication bias, and risk of bias. Results. Pooled analysis showed no significant difference in response rate (risk ratio 1.01, 95% CI [0.93–1.08]; Z test = 0.17, P=0.86) and no significant difference between JWZXG group and azapirones group (RR 0.69, 95% CI [0.45, 1.06]; Z test = 1.69, P=0.09) in rate of adverse events. Though no difference exists between JWZXG group and azapirones group in HAMA total score from baseline, JWZXG group was inferior to selective serotonin reuptake inhibitors (SSRIs) group (WMD −0.93, 95% CI [−1.64, −0.23]; Z test = 2.6, P=0.009) which had more adverse events than JWZXG group (RR 0.64, 95% CI [0.46, 0.89]; Z test = 2.63, P=0.009). Conclusions. This meta-analysis preliminarily suggests that JWZXG is as effective as azapirones, though having the same possibility of suffering AEs. JWZXG was inferior to SSRIs but causes fewer AEs in the treatment of GAD.

Improvement of psychic and somatic symptoms in adult patients with generalized anxiety disorder: examination from a duloxetine, venlafaxine extended-release and placebo-controlled trial

2008 ◽  
Vol 39 (2) ◽  
pp. 267-276 ◽  
Author(s):  
H. Nicolini ◽  
D. Bakish ◽  
H. Duenas ◽  
M. Spann ◽  
J. Erickson ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Adverse Events ◽  
Generalized Anxiety Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Factor Score ◽  
Somatic Symptoms ◽  
Controlled Study ◽  
Generalized Anxiety ◽  
Once Daily

BackgroundThis study examined the efficacy and tolerability of duloxetine and venlafaxine extended-release (XR) treatment for generalized anxiety disorder (GAD), with a secondary focus on psychic and somatic symptoms within GAD.MethodThe design was a 10-week, multi-center, double-blind placebo-controlled study of duloxetine (20 mg or 60–120 mg once daily) and venlafaxine XR (75–225 mg once daily) treatment. Efficacy was measured using the Hamilton Anxiety Rating Scale (HAMA), which includes psychic and somatic factor scores. Tolerability was measured by occurrence of treatment-emergent adverse events (TEAEs) and discontinuation rates.ResultsAdult out-patients (mean age 42.8 years; 57.1% women) with DSM-IV-defined GAD were randomly assigned to placebo (n=170), duloxetine 20 mg (n=84), duloxetine 60–120 mg (n=158) or venlafaxine XR 75–225 mg (n=169) treatment. Each of the three active treatment groups had significantly greater improvements on HAMA total score from baseline to endpoint compared with placebo (p=0.01–0.001). For the HAMA psychic factor score, both duloxetine treatment arms and venlafaxine XR demonstrated significantly greater improvement compared with placebo (p=0.01–0.001). For the HAMA somatic factor score, the mean improvement in the duloxetine 60–120 mg and venlafaxine XR groups was significantly greater than placebo (p⩽0.05 and p⩽0.01 respectively), whose mean improvement did not differ from the duloxetine 20 mg group (p=0.07). Groups did not differ in study discontinuation rate due to adverse events.ConclusionsDuloxetine and venlafaxine treatment were each efficacious for improvement of core psychic anxiety symptoms and associated somatic symptoms for adults with GAD.

scholarly journals Perbedaan Derajat Ansietas antara Penyandang Hipertensi Belum Terkontrol dengan yang Terkontrol

e-CliniC ◽  
2019 ◽  
Vol 7 (2) ◽  
Author(s):  
Cerelia E. C. Sugeng ◽  
Emma Sy. Moeis ◽  
Glady I. Rambert
Keyword(s):  
Blood Pressure ◽  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Blood Pressure Monitoring ◽  
Office Blood Pressure ◽  
Generalized Anxiety ◽  
Pressure Monitoring ◽  
Hypertensive Patients ◽  
Significant Difference ◽  
The Difference

Abstract: Hypertension and anxiety are among the group of the most common chronic disease worldwide, and according to numerous studies they are oftentimes associated each other. Patients suffered from chronic illnesses, such as hypertension, may have negative emotion that increases the risk of mental disorders, most commonly anxiety disorder. This study was aimed to assess the difference of anxiety degree between uncontrolled and controlled hypertensive patients. This was an observational analytical study with a cross-sectional design. Subjects were divided into two groups: controlled and uncontrolled hypertensive patients. Measurement of blood pressure parameter was performed by using office blood pressure monitoring. Anxiety parameter was classified based on the scoring of the Generalized Anxiety Disorder Scale (GAD-7). Data were analyzed by using the Mann-Whitney test. Subjects consisted of 60 hypertensive patients (35 males and 25 females), aged 30-70 years (mean 56.48 years). There were 35 controlled hypertension patients and 22 uncontrolled hypertensive patients. The results showed that the difference in anxiety degree based on GAD-7 between controlled hypertensive and uncontrolled hypertensive groups obtained a p-value of 0.000. In conclusion, there was a significant difference in anxiety degree between uncontrolled and controlled hypertensive patients. Screening for anxiety among hypertensive patients is a simple and cost-effective tool that may improve outcomes.Keywords: anxiety, uncontrolled hypertension, controlled hypertension Abstrak: Hipertensi dan ansietas merupakan kelompok penyakit kronik yang paling umum di seluruh dunia. Berdasarkan banyak penelitian kedua penyakit ini saling berhubungan satu sama lain. Penyandang hipertensi mungkin memiliki emosi negatif yang meningkatkan risiko terjadinya gangguan mental berupa ansietas. Ansietas dan dukungan sosial rendah akan menghambat proses penyembuhan terutama dalam mengontrol tekanan darah. Penelitian ini bertujuan untuk menge-tahui apakah terdapat perbedaan derajat ansietas antara penyandang hipertensi belum terkontrol dengan hipertensi terkontrol. Jenis penelitian ialah analitik observasional dengan desain potong lintang. Subyek penelitian dibagi menjadi dua kelompok, yaitu kelompok penyandang hipertensi belum terkontrol dan hipertensi terkontrol. Pengukuran parameter tekanan darah dilakukan dengan menggunakan alat Oscillometric digital dengan cara Office Blood Pressure Monitoring (OBPM). Parameter ansietas diklasifikasikan berdasarkan skala Generalized Anxiety Disorder Scale (GAD-7). Adanya perbedaan derajat ansietas antara kedua kelompok dinilai dengan uji Mann-Whitney. Subyek penelitian terdiri dari 60 penyandang hipertensi (35 laki-laki dan 25 perempuan) berusia 30-70 tahun (rerata 56,48 tahun). Terdapat 25 penyandang hipertensi yang belum terkontrol dan 35 penyandang hipertensi terkontrol. Hasil penelitian menunjukkan bahwa terdapat perbedaan derajat ansietas berdasarkan GAD-7 antara kedua kelompok (p=0,000). Simpulan penelitian ini ialah terdapat perbedaan bermakna dalam derajat ansietas antara penyandang hipertensi yang belum terkontrol dengan yang terkontrol. Skrining ansietas pada penyandang hipertensi merupakan modalitas penting dalam penatalaksanaan penyandang hipertensi.Kata kunci: ansietas, hipertensi belum terkontrol, hipertensi terkontrol

Validation of the Korean version of the Generalized Anxiety Disorder 7 self‐rating Scale

2020 ◽  
Author(s):  
Seung‐Hoon Lee ◽  
Cheolmin Shin ◽  
Hyounwook Kim ◽  
Sang Won Jeon ◽  
Ho‐Kyoung Yoon ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Generalized Anxiety ◽  
Self Rating ◽  
Korean Version

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 and Safety of Lesopitron in Outpatients with Generalized Anxiety Disorder

2000 ◽  
Vol 34 (2) ◽  
pp. 147-153 ◽  
Author(s):  
Anna Fresquet ◽  
Mariano Sust ◽  
Antonio Lloret ◽  
Michael F Murphy ◽  
Frederick J Carter ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Fixed Dose ◽  
First Episode ◽  
Generalized Anxiety ◽  
Efficacy And Safety ◽  
Clinical Patient ◽  
Not Otherwise Specified ◽  
History Of

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.

scholarly journals The Roles of S100B , IL-1β and IL-2 as Neuroinflammation Biomarkers in Generalized Anxiety Disorder

2021 ◽  
Author(s):  
Zhongxia Shen ◽  
Lijun Cui ◽  
Lie Ren ◽  
Mincai Qian ◽  
Yonggui Yuan ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Generalized Anxiety ◽  
Serum S100b ◽  
Significant Difference ◽  
Hamilton Anxiety Rating Scale ◽  
Neuro Inflammation ◽  
Roc Area ◽  
Inflammatory Molecules

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.

scholarly journals Ayurvedic management of generalized anxiety disorder – A case report

2018 ◽  
Vol 4 (3) ◽  
pp. 111-113
Author(s):  
Chandni. C. Pillai ◽  
◽  
James Chacko ◽  
Devipriya Soman ◽  
Mahesh C Kundagol ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Signs And Symptoms ◽  
Nasal Administration ◽  
Generalized Anxiety ◽  
Long Run ◽  
State Of Mind ◽  
Before And After ◽  
Contemporary Management

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.

scholarly journals Diagnostıc Performance Of Erythropoetin And Erythropoetin Receptor Levels In Patients With Generalized Anxiety Disorder

2020 ◽  
Author(s):  
Ergul Belge Kurutas
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Area Under The Curve ◽  
Diagnostic Value ◽  
Good Choice ◽  
Generalized Anxiety ◽  
Drug Naïve ◽  
Medical Histories ◽  
And Gender

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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