Hamilton Anxiety Scale Total Score Research Articles

Progressive muscle relaxation alleviates anxiety and improves sleep quality among healthcare practitioners in a mobile cabin hospital: a pre-post comparative study in China.

To investigate the anxiety levels, sleep quality and potential risk factors of healthcare practitioners involved in the management of COVID-19 patients in a mobile cabin hospital, and further to assess the impact of progressive muscle relaxation (PMR) on their anxiety levels and sleep quality. We conducted a pre-post self-controlled trial. Healthcare practitioners meeting the inclusion criteria underwent daily 30-min PMR sessions for seven consecutive days. The Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAMA) were used to assess the anxiety and sleep quality of subjects pre- and post-intervention. Statistical analysis was performed using the Wilcoxon test, Mann-Whitney U test, Kruskal-Wallis H test, and Spearman rank correlation. A total of 94 participants completed the study. No statistically significant differences in HAMA or PSQI total scores were observed between groups categorized based on demographic variables such as age, sex, and years of education (p > 0.05). The PSQI total score and its components (excluding sleep medication usage) exhibited a positive correlation with the HAMA total score and its psychological anxiety component (p < 0.05), and a correlation was observed between somatic anxiety manifestations and several components of the PSQI. The PSQI total scores before and after intervention were 10.0 (8.0, 13.0) and 8.0 (6.0, 9.0) respectively (p < 0.001); the HAMA total scores were 8.0 (5.0, 13.0) and 6.0 (4.0, 9.5) respectively (p < 0.001). The detection rates of poor sleep and anxiety states, along with their severity, significantly decreased post-intervention (p < 0.001). Healthcare practitioners experience prominent anxiety and sleep issues in the mobile cabin hospital. PMR can be an effective intervention for improving the anxiety and sleep quality of healthcare professionals during support periods in the mobile cabin hospital. However, trials with larger samples are necessitated to further affirm these preliminary findings.

Effectiveness and safety of Jiuwei Zhenxin granules for treating generalized anxiety disorder: A randomized controlled trial.

BackgroundGeneralized anxiety disorder (GAD) is a chronic disorder characterized by excessive, pervasive, persistent worrying that is difficult to control. Jiuwei Zhenxin granules may be safer and more effective than non-benzodiazepine anti-anxiety drugs for treating GAD. This study aimed to assess the efficacy and safety of Jiuwei Zhenxin granules alone or in combination with the benzodiazepine alprazolam.Materials and methodsA total of 710 patients were recruited from outpatient clinics and were randomly divided into two groups to receive Jiuwei Zhenxin granules (single drug group) or Jiuwei Zhenxin granules and alprazolam (combination group). The primary outcome was the response rate, which was defined as a ≥ 50% reduction from the baseline total score on the Hamilton Anxiety Scale (HAMA). Secondary outcome measures included mean changes in HAMA total score, psychological and somatic factors, Hamilton Depression Rating Scale total score, and SF-36 health survey score.ResultsAt 4 weeks after treatment, the single and combination treatment groups showed significant improvement in the HAMA total score and they did not differ significantly in response rate (77.58 vs. 79.17%) or rate of adverse drug reactions (16.22 vs. 16.07%).ConclusionJiuwei Zhenxin granules are an effective, safe, and well-tolerated treatment against GAD. Combining them with alprazolam may not significantly improve efficacy.Clinical trial registration[www.ClinicalTrials.gov], identifier [CHICTR1800020095].

Shugan Jieyu capsule improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial.

To evaluate the efficacy of the Shugan Jieyu capsule on improving sleep and emotional disorder during Coronavirus disease 2019 (COVID-19) convalescence. We conducted a randomized, double-blind, placebo-controlled trial, and recruit 200 COVID-19 convalescence patients and then divide the subjects into two groups respectively: the experimental group ( 100) and the control group ( 100). Patients in the control group were given doses as a placebo, while those in the experimental group were given Shugan Jieyu capsule. The investigators mainly observed the differences between the two groups before and after treatment in terms of the rate of reduction and the rate of efficiency in Hamilton Depression Scale (HAMD-17) total scores from baseline, and recorded the scores of Hamilton Anxiety Scale (HAMA), Patient Health Questionnaire-15 (PHQ-15), Insomnia Severity Index (ISI) and Treatment Emergent Symptom Scale at 2 week, the 4 week and the 6 week respectively after treatment, and compared the differences between the groups. And the occurrence of adverse events was recorded. After 6-week treatment, there were statistically significant differences in the rate of reduction as well as efficiency in HAMD-17 scores, HAMA Total Scores, PHQ-15 Score, ISI Score from baseline in the experimental group and control group (< 0.05). There were 4 adverse events in the experimental group and 1 in the control group. Shugan Jieyu capsule could significantly improve sleep and emotional disorder in patients during COVID-19 convalescence.

Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

PurposeTo determine the relative safety and efficacy of different doses of tandospirone in treating generalized anxiety disorder (GAD).Patients and MethodsThis parallel randomized controlled trial enrolled patients with GAD from eight centers in China. The patients were randomly assigned to 60 mg/day or 30 mg/day tandospirone groups. The primary endpoint was the overall response rate after receiving 6-week treatment. The secondary endpoints included significant response rate, clinical recovery rate, change in the Hamilton Anxiety Scale (HAMA) total score, HAMA subscale score, Hamilton Depression Scale-17 (HAMD-17), Clinical Global Impression-Severity Scale (CGI-S) score, and Impression-Improvement scale (CGI-I) score.ResultsNo significant difference was found in the overall response rate between the two groups (65.7% vs 58.4%, p = 0.213). A higher significant response rate and change in the HAMA total score were found in the 60 mg/day group. The reduction in the CGI-S score and percentage of patients with a CGI-I score of ≤2 were higher in 60 mg/day group. The reduction in HAMA somatic anxiety factor, cardiovascular symptom factor, gastrointestinal symptom factor, and HAMD-17 score were more significant in the 60 mg/day group. The incidence of total adverse events was higher in the 60 mg/day group than in the 30 mg/day group. No significant difference was found in the proportion of withdrawal due to adverse events.ConclusionBoth 60 mg/day and 30 mg/day tandospirone show good efficacy in treating patients with GAD. High doses of tandospirone may have advantages in relieving the somatic symptoms but also present disadvantages due to their high level.Trial RegistrationThe trial registration no. was NCT01614041.

Vocal Acoustic Features as Potential Biomarkers for Identifying/Diagnosing Depression: A Cross-Sectional Study.

BackgroundAt present, there is no established biomarker for the diagnosis of depression. Meanwhile, studies show that acoustic features convey emotional information. Therefore, this study explored differences in acoustic characteristics between depressed patients and healthy individuals to investigate whether these characteristics can identify depression.MethodsParticipants included 71 patients diagnosed with depression from a regional hospital in Beijing, China, and 62 normal controls from within the greater community. We assessed the clinical symptoms of depression of all participants using the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Patient Health Questionnaire (PHQ-9), and recorded the voice of each participant as they read positive, neutral, and negative texts. OpenSMILE was used to analyze their voice acoustics and extract acoustic characteristics from the recordings.ResultsThere were significant differences between the depression and control groups in all acoustic characteristics (p < 0.05). Several mel-frequency cepstral coefficients (MFCCs), including MFCC2, MFCC3, MFCC8, and MFCC9, differed significantly between different emotion tasks; MFCC4 and MFCC7 correlated positively with PHQ-9 scores, and correlations were stable in all emotion tasks. The zero-crossing rate in positive emotion correlated positively with HAMA total score and HAMA somatic anxiety score (r = 0.31, r = 0.34, respectively), and MFCC9 of neutral emotion correlated negatively with HAMD anxiety/somatization scores (r = −0.34). Linear regression showed that the MFCC7-negative was predictive on the PHQ-9 score (β = 0.90, p = 0.01) and MFCC9-neutral was predictive on HAMD anxiety/somatization score (β = −0.45, p = 0.049). Logistic regression showed a superior discriminant effect, with a discrimination accuracy of 89.66%.ConclusionThe acoustic expression of emotion among patients with depression differs from that of normal controls. Some acoustic characteristics are related to the severity of depressive symptoms and may be objective biomarkers of depression. A systematic method of assessing vocal acoustic characteristics could provide an accurate and discreet means of screening for depression; this method may be used instead of—or in conjunction with—traditional screening methods, as it is not subject to the limitations associated with self-reported assessments wherein subjects may be inclined to provide socially acceptable responses rather than being truthful.

Efficacy of Agomelatine 25-50mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies.

IntroductionThe purpose of this study is to investigate the effects of agomelatine on anxious symptoms and functional impairment in a pooled dataset from randomized placebo-controlled trials for generalized anxiety disorder (GAD).MethodsData from three randomized, placebo-controlled trials that evaluated the efficacy of agomelatine 25–50 mg were pooled. The short-term (12 weeks) efficacy of agomelatine was assessed in regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS). Meta-analysis using a random effect model was used to assess differences between groups. Remission and response rates for the HAM-A and SDS were calculated, and analyses were repeated in participants with more severe anxiety symptoms.ResultsIn total, 669 patients (340 on agomelatine; 329 on placebo) were included in the analyses. Compared to placebo, the agomelatine group had a significant reduction in HAM-A total score at week 12 (between group difference: 6.30 ± 2.51, p = 0.012). Significant effects were also found for symptom response on the HAM-A (67.1% of patients on agomelatine vs. 32.5% on placebo) and symptom remission (38.8% of patients on agomelatine vs. 17.3% on placebo). Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005). Significant effects were also found for functional response on the SDS (79.1% of patients on agomelatine vs. 43.2% of placebo) and functional remission (55.2% of patients on agomelatine vs. 25.4% on placebo). All findings for anxious symptoms and functional impairment were confirmed in the subset of more severely anxious patients. Agomelatine was well tolerated by patients.ConclusionThis meta-analysis confirms that agomelatine reduces anxiety symptoms and improves the global functioning of GAD patients.Supplementary InformationThe online version of this article (10.1007/s12325-020-01583-9) contains supplementary material, which is available to authorized users.

Abnormal Functional Asymmetry in the Salience and Auditory Networks in First-episode, Drug-naive Somatization Disorder

Evidence of abnormal functional connectivity (FC) has been implicated in patients with somatization disorder (SD). Although the importance of damage to the functional asymmetry has been established, it remains unclear as to whether abnormal intra- and inter-hemispheric FCs are related to patients with SD. We applied resting-state functional magnetic resonance imaging to first-episode, medication-naive patients with SD (n = 25) and matched healthy controls (HCs) (n = 28). The data were analyzed using parameter of asymmetry (PAS) and support vector machine (SVM). Patients with SD showed significantly lower PAS values in the left inferior temporal gyrus (ITG) and higher PAS values in the right insula compared to HCs. A negative correlation was observed between the higher PAS values in the right insula and the Hamilton Depression Scale (HAMD) sleep subscale scores (r = −0.502, p = 0.011), and positive correlations were found between the lower PAS values in the left ITG and the Hamilton Anxiety Scale (HAMA) somatic anxiety subscale scores (r = 0.443, p = 0.027) and the HAMA total scores (r = 0.456, p = 0.022). Moreover, the increased PAS values in the right insula could distinguish patients with SD from HCs with acceptable accuracy (77.36%). First-episode, treatment-naive patients with SD show disrupted asymmetry of inter- and intra-hemispheric FCs. The pattern of disrupted functional asymmetry occurs early in the course of the disease and is independent of medication status, which suggests that disrupted functional asymmetry of salience and auditory networks may be applied as early biological markers for SD.

Attribution Retraining Group Therapy and SSRIs Affect Differing Facets of Anxiety Among Chinese Patients with Various Diagnoses: A Single-Center, Prospective Study

Objectives: The NIMH launched a Research Domain Criteria (RDoC) initiative, which encouraged researchers to shift from traditional categorical conceptions of mental disorders to process-oriented psychological functions described by constructs. As anxiety was chosen to be one of the constructs in RDoC, the present study aimed to compare different anxiety improvement pattern in clinical setting, because this was important for developing treatment strategies of anxiety under RDoC frame. The study compared potential differences in trajectory of anxiety symptoms improvement in patients with various diagnoses receiving attribution retraining group therapy (ARGT) and those undergoing first-line selective serotonin reuptake inhibitors (SSRI) in clinical care setting. Methods: Participants were randomly assigned to ARGT (n = 63) or SSRI group (n = 66) group. Patients receiving ARGT had one session per week for 8 weeks. Hamilton Anxiety Scale (HAMA) was measured at 5 sequential time points during treatment. Results: The results for the HAMA total scores showed only time effect was significant, showing that no significant differences in HAMA total score between ARGT and SSRI. Additionally, both groups over time reduced HAMA score significantly. Conclusions: The results of the subscales analyses showed that both SSRI and ARGT group had effectively reduced anxiety symptoms. ARGT preferentially targeted on depressive symptoms and behaviour at interview. SSRI preferentially targeted on anxious emotions. Sequences of symptom improvement of two groups were different. Both ARGT and SSRI can effectively reduce anxiety symptoms of patients. The change process and underlying mechanism may differ in the two treatments.

The alteration of lncRNA expression in peripheral blood mononuclear cells and the effects of anti-anxiety treatment on lncRNA expression of generalized anxiety disorder patients

Objective To confirm expression alteration of long non-coding RNA(lncRNA) in peripheral blood mononuclear cells (PBMCs) of generalized anxiety disorder(GAD) patients and anti-anxiety treatment effects on aberrant expression of lncRNAs. Methods Real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) was employed in 80 GAD patients and 40 healthy participants to confirm 10 aberrant lncRNAs screened by microarray expression profiling.And 26 out of all the 80 GAD patients were recruited for lncRNA expression level testing and Hamilton Anxiety Scale(HAMA) assessments before and after 6 weeks’ treatment. Results Six of ten lncRNAs selected by array profiling (lncRNA4(7.44±2.26), lncRNA5(6.83±2.28), lncRNA6(8.09±2.30), lncRNA8(9.10±2.36), lncRNA9(7.66±2.12), lncRNA10(7.34±2.12)) were verified by qRT-PCR that the lncRNA expression levels were significantly up regulated in GAD patients compared with healthy controls(Z=-3.022--1.996, P<0.05 or 0.01), and lncRNA4(9.73±2.53), lncRNA6(9.91±2.01), lncRNA8(10.48±1.68), lncRNA9(9.02±1.58), lncRNA10(9.04±2.08) were down regulated significantly after 6 weeks’ anti-anxiety treatment(Z=-3.180--2.530, P<0.05 or 0.01) along with signicant reduction of total HAMA score (11.19±8.37), dimension scores of somatic anxiety(5.31±4.76), psychic anxiety(5.88±3.82) (t=5.502-5.971, P<0.01). The alterations of lncRNA4, lncRNA6, lncRNA8, lncRNA9, lncRNA10 were positively correlated with that of HAMA total score and psychic anxiety score(r=0.39-0.69, P<0.05 or 0.01), and alteration of lncRNA6, lncRNA8, lncRNA10 had positive correlation with that of somatic anxiety score(r=0.44-0.59, P<0.01). Conclusion The expression level of lncRNA4, lncRNA5, lncRNA6, lncRNA8, lncRNA9, lncRNA10 are up-regulation in PBMCs of GAD patients and anti-anxiety treatment can reverse the expression level of lncRNAs. Alteration of lncRNA expression has osculatory association with improvement of anxious symptom. Key words: Generalized anxiety disorder; Peripheral blood mononuclear cell; lncRNA; Differential expression

The efficacy of group cognitive-behavioural therapy plus duloxetine for generalised anxiety disorder versus duloxetine alone.

To explore whether and how group cognitive-behavioural therapy (GCBT) plus medication differs from medication alone for the treatment of generalised anxiety disorder (GAD). Hundred and seventy patients were randomly assigned to the GCBT plus duloxetine (n=89) or duloxetine group (n=81). The primary outcomes were Hamilton Anxiety Scale (HAMA) response and remission rates. The explorative secondary measures included score reductions from baseline in the HAMA total, psychic, and somatic anxiety subscales (HAMA-PA, HAMA-SA), the Hamilton Depression Scale, the Severity Subscale of Clinical Global Impression Scale, Global Assessment of Functioning, and the 12-item Short-Form Health Survey. Assessments were conducted at baseline, 4-week, 8-week, and 3-month follow-up. At 4weeks, HAMA response (GCBT group 57.0% vs. control group 24.4%, p=0.000, Cohen's d=0.90) and remission rates (GCBT group 21.5% vs. control group 6.2%, p=0.004; d=0.51), and most secondary outcomes (all p<0.05, d=0.36-0.77) showed that the combined therapy was superior. At 8weeks, all the primary and secondary significant differences found at 4weeks were maintained with smaller effect sizes (p<0.05, d=0.32-0.48). At 3-month follow-up, the combined therapy was only significantly superior in the HAMA total (p<0.045, d=0.43) and HAMA-PA score reductions (p<0.001, d=0.77). Logistic regression showed superiority of the combined therapy for HAMA response rates [odds ratio (OR)=2.12, 95% confidence interval (CI) 1.02-4.42, p=0.04] and remission rates (OR=2.80, 95% CI 1.27-6.16, p=0.01). Compared with duloxetine alone, GCBT plus duloxetine showed significant treatment response for GAD over a shorter period of time, particularly for psychic anxiety symptoms, which may suggest that GCBT was effective in changing cognitive style.

Post-marketing Re-evaluation of Tongxiening Granules () in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial.

To evaluate the efficacy and safety of Tongxiening Granules (, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea (IBS-D). A randomized, double-blind, double-dummy, and positive parallel controlled clinical trial was conducted from October 2014 to March 2016. Totally 342 patients from 13 clinical centers were enrolled and randomly assigned (at the ratio of 1:1) to a treatment group (171 cases) and a control group (171 cases) by a random coding table. The patients in the treatment group were administered orally with TXNG (5 g per time) combined with pinaverium bromide Tablet simulator (50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator (5 g per time) combined with pinaverium bromide Tablets (50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief (AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and the recurrence rate at follow-ups. Safety indices including the adverse events (AEs) and related laboratory tests were evaluated. Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set (FAS) and per protocol set (PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group (147/171,86.0%) was higher than the control group (143/171, 83.6%) by FAS (P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups (P>0.05). The recurrence rate at 8-week follow-up was 12.35% (10/18) in treatment group and 15.79% (12/76) in control group, respectively (P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups (P>0.05). Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide. (No. ChiCTR-IPR-15006415).

12-week double-blind randomized multicenter study of efficacy and safety of agomelatine (25–50 mg/day) versus escitalopram (10–20 mg/day) in out-patients with severe generalized anxiety disorder

Treatment of severely symptomatic patients with generalized anxiety disorder (GAD) raises particular concerns for clinicians.This 12-week double-blind study evaluated the efficacy of agomelatine (25–50 mg/day) in the treatment of patients with severe GAD, using escitalopram (10–20 mg) as active comparator. The primary outcome measure was the change from baseline of the total score on the Hamilton Anxiety scale (HAM-A) at week 12. Secondary outcome measures included rate of response to treatment (at least 50% score reduction from baseline) in the HAM-A psychic and somatic anxiety sub-scores, Clinical Global Impression severity and change scores, the Toronto Hospital Alertness Test, the Snaith-Hamilton Pleasure Scale, and the Leeds Sleep Evaluation Questionnaire Scores.Sixty one clinical centers (Australia, Canada, Czech Republic, Finland, Germany, Hungary, Poland, Russia, Slovakia) participated from April 2013 to February 2015.Patient characteristics and demographic data were comparable between treatment groups. Both treatments were associated with a clinically significant decrease in HAM-A total score at week 12; the non-inferiority of agomelatine versus escitalopram was not demonstrated (E(SE) = −0.91(0.69), 95%CI = [−2.26, 0.44], p = 0.195). At week 12, the response rate was 60.9% in the agomelatine group, and 64.8% in the escitalopram group. In both treatment arms, HAM-A psychic and somatic anxiety scores decreased, alertness and sleep parameters improved, and ability to experience pleasure increased. In these secondary outcome measures, there were no significant differences between the treatment groups. Agomelatine was well-tolerated, with a lower incidence of adverse events than escitalopram.Agomelatine and escitalopram are efficacious in treating GAD patients with severe symptoms.

Early improvement with pregabalin predicts endpoint response in patients with generalized anxiety disorder: an integrated and predictive data analysis.

Generalized anxiety disorder (GAD), a common mental disorder, has several treatment options including pregabalin. Not all patients respond to treatment; quickly determining which patients will respond is an important treatment goal. Patient-level data were pooled from nine phase II and III randomized, double-blind, short-term, placebo-controlled trials of pregabalin for the treatment of GAD. Efficacy outcomes included the change from baseline in the Hamilton Anxiety Scale (HAM-A) total score and psychic and somatic subscales. Predictive modelling assessed baseline characteristics and early clinical responses to determine those predictive of clinical improvement at endpoint. A total of 2155 patients were included in the analysis (1447 pregabalin, 708 placebo). Pregabalin significantly improved the HAM-A total score compared with the placebo at endpoint, treatment difference (95% confidence interval), -2.61 (-3.21 to -2.01), P<0.0001. Pregabalin significantly improved HAM-A psychic and somatic scores compared with placebo, -1.52 (-1.85 to -1.18), P<0.0001, and -1.10 (-1.41 to -0.80), P<0.0001, respectively. Response to pregabalin in the first 1-2 weeks (≥20 or ≥30% improvement in HAM-A total, psychic or somatic score) was predictive of an endpoint greater than or equal to 50% improvement in the HAM-A total score. Pregabalin is an effective treatment option for patients with GAD. Patients with early response to pregabalin are more likely to respond significantly at endpoint.

Modified Suanzaorentang Had the Treatment Effect for Generalized Anxiety Disorder for the First 4 Weeks of Paroxetine Medication: A Pragmatic Randomized Controlled Study.

Background. Paroxetine does not show satisfactory therapeutic effect for generalized anxiety disorder (GAD) patients for the first 2–4 weeks of medication. Diazepam is always concurrently used although it has some shortcomings such as physical dependence and withdrawal reactions. In this study, we aimed to identify whether modified Suanzaorentang (MSZRT), a combined Chinese formula including Suanzaorentang (SZRT) and Zhizichitang (ZZCT), could control the anxiety of GAD for the first 4 weeks of paroxetine medication. Methods. 156 GAD patients were randomized to the treatment of paroxetine, paroxetine-diazepam, or paroxetine-MSZRT for 4 weeks. Hamilton Anxiety Scale (HAMA) Test and Self-Rating Anxiety Scale (SAS) Test were determined each week as the evaluation of clinical efficacy. Adverse events (AEs) were also closely observed by performing the Treatment Emergent Symptom Scale (TESS) Test. Results. Both paroxetine-MSZRT and paroxetine-diazepam decreased more HAMA and SAS total scores than paroxetine from weeks 1 to 3. Paroxetine-MSZRT as well as paroxetine-diazepam had an obviously higher onset rate than paroxetine in each week. After 4 weeks' treatment, the overall effectiveness rate in the paroxetine-MSZRT group (90.00%) was obviously higher than those of the paroxetine group (74.42%) but did not significantly differ from the paroxetine-diazepam group (93.88%). Conclusion. MSZRT had the treatment effect for GAD when paroxetine was used for the first 4 weeks.

Correlation between the level of microRNA expression in peripheral blood mononuclear cells and symptomatology in patients with generalized anxiety disorder

This study investigated the correlation between the level of microRNA expression in peripheral blood mononuclear cells (PBMCs) and symptomatology in patients with generalized anxiety disorder (GAD). MicroRNA array was performed in peripheral blood mononuclear cells (PBMCs) obtained from GAD patients with gender, age, ethnicity-matched healthy controls. Then real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) was used to verify the top 7 miRNAs with the highest fold-change values in 76 GAD patients and 39 healthy controls. It demonstrated that 5 miRNAs showed significantly differences in expression levels (P<0.01). These 5 GAD-associated miRNAs were finally selected into our study to analyze the association between the plasma level of miRNAs expression and symptomatology scores in Hamilton Anxiety Scale (HAMA). Results showed that the level of miR-4505 and miR-663 was negatively correlated with the total HAMA scores in GAD patients (r=0.2228, r=0.264 P<0.05). MiR-663 was selected into the regression equation of HAMA total scores and psychic anxiety symptomatology scores, and it could explain 5.3% of the HAMA total scores and 15.3% of the anxiety symptomatology scores. This study analyzed preliminarily possible circulating miRNAs expression changes in GAD patients, and the expression level of miR-663 highly correlated with psychic anxiety symptoms, further molecular mechanism of which needs to be explored.

A comparison of anxiety, depression and attachment in tender age and adult pregnancy in Southeastern Anatolia Region.

Object: The aim of this study is to compare anxiety, depression and attachment in tender age and adult pregnants in a township of Southeastern Anatolia Region. Method: The study was conducted in a hospital in southeast of Turkey. 56 patients of obstetrics and gynecology clinic who did not have a psychiatric diagnosis and who were there for a routine assessment were involved in the study. Only the patients who could communicate Turkish at a sufficient level contributed to the study. Help was received from a hospital employee who was fluent in Kurdish and Arabic when necessary. Tender age and adult pregnant were evaluated by Hamilton Anxiety and Hamilton Depression Rating Scale, Parental Bonding Instrument (PBI), Adult Attachment Style Scale (AAS) and sociodemographic questionnaire. Results: Between two groups statistically no significant difference was found in mother care, mother overprotection and father care subscales of parental bonding instrument (PBI); however father overprotection subscales were found to be significantly higher in tender age pregnant women compared to adult pregnant women. Statistically no significant difference was found between two groups with regards to Hamilton Depression scale and Hamilton Anxiety scale total scores. Avoidant attachment style was found to be associated with depression in tender age pregnant women although such association was not found for the group of adult pregnant women. Conclusion: A secure attachment style during pregnancy will be passed on to the child by mother and the child as an individual under the influence of this bonding pattern will have its greater effects in its life and this primary attachment status will be transmitted to offspring. That is why it is important to break insecure attachments in risk groups and therefore developing new healthy attachment patterns should be aimed. The problems in the southeast of Turkey such as the language barrier and low literacy rate as well as the difficulty in applying the questionnaire make it difficult to conduct studies. Future research especially with women in this area is needed.

Association study on personality and plasma cortisol level in the patients with generalized anxiety disorder

Objective To study the correlation of personality characteristics and plasma cortisol levels in the patients with generalized anxiety disorder. Methods According to Diagnostic and Statistical Manual of Mental Disorders(DSM-Ⅳ), 38 patients with generalized anxiety disorder and 39 normal controls were assessed with Hamilton anxiety scale(HAMA), generalized anxiety disorder scale(GAD-7), penn state worry questionnaire(PSWQ), symptom checklist-90(SCL-90)and eysenck personality questionnaire(EPQ). Electrochemiluminescence was used to test plasma cortisol concentration. Results The EPQ-N score in the patients was significantly higher than that in normal controls(t=14.307, P<0.01). Furthermore, N score in the patients showed a significantly positive correlation with HAMA total score, SCL-90 total score, somatization score, interpersonal sensitivity score, depression score and anxiety score (r=0.492-0.977, P<0.01). Plasma cortisol levels in patients with generalized anxiety disorder((668.50±60.22)nmol/L) were significantly higher than those ((345.35±58.91)nmol/L) in normal controls (t=23.802, P<0.01). Plasma cortisol concentrations displayed a significantly positive correlation with N score, GAD-7, PSWQ, HAMA total score, SCL-90 total score, somatization score, interpersonal sensitivity score, depression score, and anxiety score(r=0.501-0.995, P<0.01). Conclusion Plasma cortisol levels in the patients with generalized anxiety disorder are higher than those in normal controls. Plasma cortisol levels are related to the mental health.Patients with generalized anxiety disorder tend to be neuroticism. Key words: Generalized anxiety disorder; Personality; Cortisol; Pearson correlation analysis

Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder

Lack of standardization across sites and raters, poor interrater reliability, and possible scoring bias affecting the primary outcome measure contribute to a high failure rate in anxiety trials. Remote centralized raters who are blinded to protocol inclusion and exclusion criteria as well as visit number may standardize assessments across raters and eliminate scoring bias, decreasing placebo response and thereby increasing signal detection. The purpose of the primary study was to test the safety and efficacy of an anxiolytic in a double-blind, placebo-controlled (no active comparator), multicenter trial. However, there was an additional prospective objective to explore site ratings compared with remote centralized ratings in the cohort of subjects on placebo. Site raters assessed subjects 6 times over an 8-week period. The primary outcome measure was the week 8 site-rated Hamilton Anxiety Scale (HAM-A). Remote centralized raters by telephone independently rated these subjects on the HAM-A at baseline and week 6. Of the 122 subjects selected by site raters and therefore randomized, remote centralized raters would have admitted 59 (48%) and excluded 63 (52%), based on their HAM-A ratings. The mean change from baseline in HAM-A total score in the placebo group admitted to the study by site raters was 9.3, significantly higher than the 5.9 point mean change on placebo as measured by the remote centralized raters.The data are consistent with the potential for qualification bias at baseline when rated by sites. The results make a strong case for using strategies to ensure that baseline scoring is truly independent of the pressure to enroll.

Pregabalin for the treatment of patients with generalized anxiety disorder with inadequate treatment response to antidepressants and severe depressive symptoms.

To evaluate the effectiveness of pregabalin in patients with resistant generalized anxiety disorder (GAD) and severe depressive symptoms, we carried out a post-hoc analysis of a multicenter, prospective, and observational 6-month study. We included patients who were at least 18 years old, fulfilled the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) criteria for GAD, showed inadequate responses to previous courses of antidepressant treatment, had Montgomery-Asberg Rating Scale scores of at least 35, had not received pregabalin previously, and were prescribed pregabalin upon entry into this study. We included 1815 patients fulfilling the DSM-IV criteria for GAD, and 133 (7.3%) fulfilled the selection criteria for these analyses. Ninety-seven percent of the patients received pregabalin (mean dose: 222 mg/day) in combination with other psychotropics. The Hamilton Anxiety Scale total score was reduced by a mean of 20.3 points (95% confidence interval, 22.1-18.4) (57.2% reduction) at month 6. Pregabalin also ameliorated comorbid depressive symptoms, with a reduction in the mean score of the Montgomery-Asberg Rating Scale of 22.3 points (95% confidence interval, 24.2-20.4) (56.6% reduction). Our results suggest that pregabalin, as part of a combination regimen with antidepressants and/or benzodiazepines, might be effective for the treatment of patients with GAD who have shown inadequate response to previous antidepressants and have severe depressive symptoms.

Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial

The anxiolytic effect of Silexan, a patented active substance with an essential oil produced from Lavandula angustifolia flowers, was investigated in patients with anxiety-related restlessness and disturbed sleep. 170 out-patients with a diagnosis of restlessness (ICD-10 R45.1), a Hamilton Anxiety Scale (HAMA) total score ≥18 points and ≥2 points for HAMA items ‘Tension’ and ‘Insomnia’ participated in this randomized, double-blind trial and received 80mg Silexan or placebo once daily for 10 weeks. Patients with clinically important other psychiatric or neurological disorders potentially interfering with the assessment of treatment efficacy were excluded. Outcome variables were the HAMA as well as the Pittsburgh Sleep Quality Index (PSQI), the Zung Self-rating Anxiety Scale, a State Check inventory and the Clinical Global Impressions questionnaire. In the Silexan group the HAMA total score decreased from an average of 25.5±6.0 points at baseline to 13.7±7.0 points at treatment end, compared to a decrease from 26.5±6.1 to 16.9±9.8 for placebo, corresponding to decreases of 12.0 and 9.3 points (marginal means), respectively (group difference: p=0.03, ANCOVA with factor treatment and baseline value as covariate). In all outcome measures the treatment effect of Silexan was more pronounced than with placebo. According to the HAMA, 48.8% and 33.3% of the patients were responders (Silexan, placebo; reduction ≥50%; p=0.04) and 31.4% and 22.6% achieved remission (HAMA<10; p=0.20). 33.7% (Silexan) and 35.7% (placebo) of the participants reported adverse events. The study confirms the calming and anxiolytic efficacy of Silexan.