scholarly journals Effect of long-term administration of clonazepam, carbamazepine, and valproate on cognitive, psychological, and personality changes in adult epilepsy: a case–control study

2021 ◽  
Vol 28 (1) ◽  
Author(s):  
Gellan K. Ahmed ◽  
Khaled Elbeh ◽  
Yasser Elserogy ◽  
Sayed Mostafa
Keyword(s):  
Behavioral Problems ◽  
Minnesota Multiphasic Personality Inventory ◽  
Rating Scale ◽  
Structured Interview ◽  
Anxiety And Depression ◽  
Related Factors ◽  
Adult Intelligence Scale ◽  
Personality Changes ◽  
Group 3 ◽  
Group 1

Abstract Background Epilepsy can be treated with antiepileptic drugs (AEDs) which may have psychiatric and behavioral side effects. Additionally, the availability of new AEDs has increased, and our understanding of variability to combinations of several AEDs has evolved. Based on the treatment outcomes of carbamazepine, valproate, and clonazepam, this study aims to compare the cognitive function, personality, and psychological issues associated with these drugs and evaluate seizure-related factors related to them. Only 139 participants were included. Clonazepam was used as an add-on antiepileptic drug. Participants were categorized into five groups: group 1, carbamazepine; group 2, valproate; group 3, carbamazepine and clonazepam; group 4, valproate and clonazepam; and group 5, epileptic patients without AED. All participants were assessed using the Wechsler Adult Intelligence Scale (WAIS), Structured Interview for the Five-Factor Personality Model (SIFFM), Hamilton Anxiety and Depression Rating Scale, and Minnesota Multiphasic Personality Inventory-2 (MMPI-2). Results In the WAIS, group 1 had the worst mean of verbal intelligence quotient (IQ). Moreover, group 3 was more vulnerable in symptomatic response in all subscales of MMPI-2 except the masculinity–femininity subscale and a high percentage in moderate severity of anxiety and depression in the Hamilton scales. Conclusions The use of clonazepam and carbamazepine might increase the incidence of behavioral problems especially increased severity of anxiety and depression and decreased performance IQ compared with either clonazepam or carbamazepine alone. Moreover, patients with carbamazepine treatment might have more personality changes and lowered verbal IQ than others.

Stress-protective effects of micronized progesterone in treatment of anxiety disorders in pregnant women after in vitro fertilisation

GYNECOLOGY ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. 346-353
Author(s):  
Natalya I. Tapilskaya ◽  
Mikhail S. Nekrasov ◽  
Inna O. Krikheli ◽  
Ksenia V. Ob'edkova ◽  
Alexander M. Gzgzyan ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Pregnant Women ◽  
Rating Scale ◽  
Depression Scale ◽  
Anxiety And Depression ◽  
In Vitro Fertilisation ◽  
Group 3 ◽  
The Mean ◽  
Micronized Progesterone

Aim. To study a stress-protective efficacy of micronized progesterone (MP) in pregnant women with anxiety disorders after in vitro fertilisation (IVF). Materials and methods. We conducted a prospective, comparative open-label randomized trial in two IVF-clinics. A total of 98 pregnant women after IVF with anxiety disorders were recruited at the 9th week of pregnancy. Progesterone supplementation after IVF for luteal phase support was administered out until 9 weeks gestation. Then, after randomization, group 1 (n=35) received 400 mg per day of MP vaginally, group 2 (n=33) received 400 mg of MP orally, group 3 (n=30) was comparative for the other groups. The duration of progesterone treatment was 12 weeks. The Spielberger State Trait Anxiety Inventory (STAI), the Montgomerysberg depression rating scale (MADRS), Hospital Anxiety and Depression Scale (HADS), and the Epworth Sleepiness Questionnaires (ESQ) were used to compare maternal mood at 9 weeks (day of randomization) after delivery and at 283, 565, 847 days after randomization. Results. The mean STAI sumscore in MP-groups was significantly lower than in group 3 starting from day 565 and continued until the end of the study. There were no significant differences between vaginal and oral administration of progesterone. There were no significant differences between the mean sumscores when questioning on the HADS, MADRS and ESQ. Conclusion. Prolonged use of MP in pregnant women with anxiety disorders led to the prevention of manifestations of an increase in anxiety and depression. The stress-protective and neuromodulating properties of MP can determine additional indications for its prolonged administration in women with anxiety disorders and/or premorbid history.

Anticancer treatment and cognitive functions in elderly cancer patients: A prospective study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8543-8543
Author(s):  
A. M. Minisini ◽  
P. Ermacora ◽  
S. Russo ◽  
G. Cardellino ◽  
C. Andreetta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Endocrine Therapy ◽  
Cognitive Functions ◽  
Therapy Group ◽  
Anxiety And Depression ◽  
Elderly Cancer Patients ◽  
Anticancer Treatment ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

8543 Background: It has been reported that anticancer treatment may alterate cognitive functions in cancer patients but very few prospective studied addressed this issue. Moreover, little is known about the cognitive impact of anticancer treatment in elderly cancer patients. We aimed at investigating the effect on cognitive functions of antiblastic chemotherapy and endocrine therapy in a consecutive series of elderly cancer outpatients. Methods: We evaluated cognitive functions by means of the Cambridge Cognitive Examination (CAMCOG) test and the Mini-Mental Scale Examination (MMSE) at baseline (before anticancer systemic treatment), after 3 months and after 6 months in cancer patients aged more than 65 years. Mood disturbances such as anxiety and depression were also evaluated (Hospital Anxiety and Depression Scale); comprehensive geriatric assessment and blood tests were performed at each evaluation. Results: Sixty patients were enrolled, 15 patients received chemotherapy (group 1), 13 patients received endocrine therapy (group 2) and 32 patients had neither chemotherapy nor endocrine therapy (group 3, control). Fifty-eight (97%) patients had no evidence of disease at the time of assessment. Median age was 71.5, 73 and 71 years in group 1, 2 and 3, respectively. At baseline, median Activities of Daily Living (ADL) score, Instrumental Activity of Daily Living (IADL) score, number of comorbidities and concomitant medications were 6, 8, 5, 1 in group 1, and 6, 8, 3, 2 in group 2, and 6, 8, 4, 2 in group 3, respectively. Median hemoglobin value was 12.9, 12.8, 13.3 g/dl in group 1, 2 and 3 respectively. At baseline, no significant unbalance was evident among groups. There was a statistically significant correlation between ADL or IADL score and CAMCOG total score (Spearman test, rho=0.4, p<0.05). Higher scolarity level was associated with higher CAMCOG total score. No deterioration of CAMCOG score was evident in group 1, 2 and 3 after 3 and 6 months (paired t-test p>.05); the separate analyses for the different items in CAMCOG test did not evidence any deterioration in time in the 3 groups. No worsening was seen in MMSE. Conclusions: Our study showed that anticancer treatment is not associated with rapid cognitive deterioration in elderly cancer patients. No significant financial relationships to disclose.

The Relationship Between Anxiety and Depression in Children: Rating Scales and Clinical Variables*

1987 ◽  
Vol 32 (6) ◽  
pp. 433-439 ◽  
Author(s):  
C. Stavrakaki ◽  
B. Vargo ◽  
L. Boodoosingh ◽  
N. Roberts
Keyword(s):  
Depressive Symptoms ◽  
Behavioral Problems ◽  
Rating Scales ◽  
Rating Scale ◽  
Anxiety And Depression ◽  
Clinical Variables ◽  
Observer Ratings ◽  
One Year ◽  
The Relationship ◽  
Depressed Children

The present study examined the relationship between anxiety and depression in children in the context of proposed adult models. The results support the qualitative distinction between anxious and depressed patient groups on subsets of rating scale measures and clinical variables. In contrast to anxious children who were younger, (day patients) had been ill for longer than one year, presented with behavioral problems, and were low on observer ratings of depressive symptoms; depressed children were older, (inpatients) had been ill for less than one year, presented with emotional problems and were high on observer ratings of both anxious and depressive symptoms. The finding that the older depressed children were concurrently anxious while the younger anxious children were not concurrently depressed is discussed from the viewpoint of a hypothesized temporal sequence between anxiety and depression. The implication of this and other related findings are discussed in regard to their importance for differential diagnosis and prognosis.

scholarly journals Adolescent Enrollment in Psychosocial Care: Do Parents Make a Difference?

2020 ◽  
Vol 17 (19) ◽  
pp. 7066
Author(s):  
Katerina Paclikova ◽  
Zuzana Dankulincova Veselska ◽  
Andrea Madarasova Geckova ◽  
Jitse P. van Dijk ◽  
Sijmen A. Reijneveld
Keyword(s):  
Socioeconomic Position ◽  
Behavioral Problems ◽  
Psychosocial Care ◽  
Emotional And Behavioral Problems ◽  
Parenting Support ◽  
Group 4 ◽  
Parental Characteristics ◽  
Lower Socioeconomic ◽  
Group 3 ◽  
Group 1

Care for adolescents with emotional and behavioral problems (EBP) is frequently unequally distributed. Parents may play a role in the access to this care. Therefore, the aim was to explore the association between parental characteristics and their adolescent’s enrollment in psychosocial care. We used data from the Care4Youth cohort study. Our sample consisted of 446 adolescents (mean age 13.22 years, 48% boys) and 382 parents (mean age 42.95 years, 14% males). EBP combined with enrollment created four groups: 1, no EBP/no care; 2, no EBP/care; 3, EBP/no care; 4, EBP/care. We assessed differences in parental characteristics among the groups. Group 2 had a significantly lower socioeconomic position (p < 0.01), more psychological distress (p < 0.001), poorer supervision (p < 0.001) and lower family social support (p < 0.05) than Group 1. Group 4 had a significantly lower socioeconomic position (p < 0.01) and poorer supervision (p < 0.001) than Group 1. Group 3 had significantly poorer supervision (p < 0.001) than Group 4. The poor supervision in Group 3 requires attention, as these adolescents receive no care. The quality of parental supervision should be addressed generally, e.g., by providing better parenting support and more parental training.

scholarly journals Clinical Impact of Psychopathy on Bipolar Disorder

Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 165
Author(s):  
Giuseppina Calabrò ◽  
Antonio Francesco Musolino ◽  
Andrea Adolfo Filippo ◽  
Renato de Filippis ◽  
Elvira Anna Carbone ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Personality Disorders ◽  
Rating Scale ◽  
Psychopathic Personality ◽  
Type I ◽  
Young Mania ◽  
Manic Symptoms ◽  
Affective Symptoms ◽  
Group 3 ◽  
Group 1

Background and Objectives. Bipolar disorder (BD) is associated with a significant burden due to affective symptoms and behavioral manifestations, but also cognitive and functional impairment. Comorbidity with other psychiatric conditions, including personality disorders, is frequent. The comorbidity with psychopathy deserves special consideration given that both disorders share some clinical characteristics, such as grandiosity, risky behavior or poor insight, among others, that can worsen the outcome of BD. Therefore, this study aimed to evaluate the prevalence of psychopathy in a sample of clinically stabilized patients with BD and its impact on the severity of BD. Materials and Methods. A sample of 111 patients with BD (38 type I and 73 type II) was studied. The Hamilton Depression Rating Scale (HAM-D) and the Young Mania Rating Scale (YMRS) served to assess the severity of BD. Psychopathy was measured by means of the Psychopathic Personality Inventory-Revised (PPI-R). Patients were divided into three groups according to the severity of psychopathy (Group 1: no psychopathy; Group 2: “psychopathic” trait; Group 3: clinical psychopathy). Other measures regarded impulsiveness (Barratt Impulsiveness Scale-11, BIS-11) and empathy (Empathy Quotient, EQ). Comparisons of mania, depression, impulsivity and empathy scores were run with MANOVA considering psychopathy and diagnosis as independent variables. Results. The prevalence of psychopathy was 5.4%. A significant association between the level of psychopathy and YMRS, attentional/cognitive impulsivity and motor impulsivity scores emerged. No interaction between psychopathy and BD diagnosis was found. Post hoc analysis demonstrated significantly higher YMRS scores in Group 3 than in Group 1; that is, patients with psychopathy have more manic symptoms. Conclusion. Psychopathy seems quite frequent among patients with BD. The association of psychopathy with BD results in higher impulsivity and manic symptoms. In light of this, psychopathy should be investigated when assessing patients with BD, regardless of the comorbidity of BD with other personality disorders.

scholarly journals Comparison of Sustained Natural Apophyseal Glides and Maitland Manual Therapy in Non-Specific Neck Pain on Numeric Pain Rating Scale and Neck Disability Index

2018 ◽  
Vol 23 (4) ◽  
pp. 457-462
Author(s):  
Fahad Tanveer ◽  
Adnan Afzal ◽  
Muhammad Adeel ◽  
Sana Shahid ◽  
Maham Masood
Keyword(s):  
Neck Pain ◽  
Functional Status ◽  
Rating Scale ◽  
Neck Disability Index ◽  
Numeric Pain Rating Scale ◽  
Group 3 ◽  
Group 2 ◽  
Neck Disability ◽  
Pain Rating Scale ◽  
Group 1

Incidence of neck pain is increasing day by day due to changed, sedentary, non-ergonomic environment and life style. This becomes the reason of an increased load of human resource and cost. To shed this load of resources and cost, it’s essential to sort out means which give real relief to this increasinglysignificant problem. To compare outcomes of sustained natural apophyseal glides (SNAGs) versus Maitland manual therapy in improving non-specific neck pain. It was a quasi-experimental study design. The study was conducted in Chaudhary Muhammad Akram, Teaching & Research Hospital, Lahore and SuriyaAzeem Teaching Hospital, Lahore within six months from June 2015 to December 2015. A total of 75 subjects with non-specific neck pain using non-probability convenience sampling technique who fulfilled the specific inclusion and exclusion criteria were randomly allocated to three groups; group 1 received SNAGs,group 2 Maitland mobilization and group 3 conventional treatment. Baseline, post-intervention and follow up readings were taken through numeric pain rating scale (NPRS) for pain intensity, neck disability index (NDI) for functional status,goniometer for range of motion and manual muscle testing for muscle strengthof neck. The subject in each group were given twelve sessions, with three sessions a week. Data were analyzed through statistical package of social sciences (SPSS) 21. The results of each group showed pre-treatment pain intensity for group 1 was 7.04+1.338 that changed to 3.52+0.714 and for group 2 it was changed from 7.52+0.872 to 5.16+0.850 and 7.16+0.943 to 5.12+0.781 for group 3. The NDI score for group 1, 2 and 3 were 31.56+5.560, 25.040+7.086 and 25.560+5.477 that were changed to 13.120+2.759, 16.360+2.899 and 12.600+2.020 respectively. The one way ANOVA test compared mean of three groups and p-value for painintensity after treatment was p=0.000 and for functional status p=0.000. The study showed that SNAGs mobilization was more effective in the management of non-specific neck pain and also conventional treatment improved functional status of neck than Maitland mobilization.

scholarly journals O impacto da formação no desempenho da arbitragem no futebo

2021 ◽  
Vol 21 (1) ◽  
pp. 43-59
Author(s):  
Sérgio Mendes ◽  
Bruno Travassos ◽  
Ema P. Oliveira
Keyword(s):  
Training Programs ◽  
Training Group ◽  
Training Model ◽  
Structured Interview ◽  
Formal Training ◽  
Career Academy ◽  
Group 3 ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Los responsables del arbitraje a nivel mundial han alentado el desarrollo de programas de formación formal, adecuados a las necesidades de la actividad de los árbitros de fútbol. De ahí que, este estudio tuvo como objetivo: i) analizar las percepciones de los árbitros expertos sobre la introducción de programas de formación formal a lo largo de su carrera (Academia de Arbitraje - AA - para árbitros de fútbol) en Portugal; ii) comprobar el impacto de AA en las calificaciones de los árbitros entre los árbitros que participaron en este modelo de capacitación y los que no lo hicieron. Para ello, se realizaron 2 estudios complementarios. En el estudio 1, se entrevistó a cinco expertos portugueses en arbitraje de fútbol, partiendo de una entrevista semiestructurada, con el análisis de contenido. En el estudio 2, se recogieron las calificaciones de los árbitros de la plantilla nacional 2009-18 (N = 243), que se agruparon de acuerdo con su formación: Grupo 1 (n = 82) promovidos directamente; Grupo 2 (n = 86) promovidos de categoría tras su formación en AA; Grupo 3 (n = 75) los que no fueron promovidos. Los resultados del estudio 1 revelaron: i) un cambio significativo en la estructuración de la formación de los árbitros portugueses tras la temporada 2013-14; ii) la existencia de lagunas en el proceso formativo y de clasificación; iii) la existencia de una cultura de individualismo y exigencia en el sector. Los resultados del estudio 2 solo revelaron diferencias significativas entre G3 y G2. Se concluye que se observaron mejoras en el proceso de formación, aunque no hubo mejoras significativas en el desempeño a nivel de la clasificación. La variable experiencia se identificó como un factor que influyó positivamente en la clasificación. Those responsible for global football refereeing have encouraged the development of formal training programs that meet the requirements of referee activity. Thus, this study aimed to: i) analyze the perceptions of expert referees about the introduction of formal training programs throughout the career (Academy of refereeing - AA - for football referees) in Portugal; (ii) verify the impact of the AA on the referees' performance in referees who participated in this training model and those who did not participate. For this purpose, 2 complementary studies were conducted. In study 1, five Portuguese football refereeing experts were interviewed, based on a semi-structured interview, with content analysis. In study 2, the performance of the referees of the national ranking of 2009-18 (N=243) were collected, and were grouped according to their training: Group 1 (n=82)  promoted directly; Group 2 (n=86) promoted from categories after training in AA; Group 3 (n=75) elements that have not been promoted. The results of study 1 revealed: i) a significant change in the training curriculum of Portuguese referees since 2013-14; (ii) the existence of gaps in the formative and classification process; iii) the existence of a culture of individualism and competition in the sector. The results of study 2 revealed only significant differences between the G3 and G2 groups. It was concluded that improvements in the training process were realized, although there were no significant improvements in performance. Experience was identified as the variable that positively influenced the referees’ performance. Os responsáveis pela arbitragem em termos mundiais têm estimulado o desenvolvimento de programas de formação formal que respondam às exigências da atividade de árbitro de futebol. Assim, este estudo pretendeu: i) analisar a perceções de árbitros especialistas sobre a introdução de programas de formação formais ao longo da carreira (Academia de Arbitragem – AA - para árbitros de futebol) em Portugal; ii) verificar o impacto da AA nas classificações dos árbitros entre árbitros que participaram neste modelo de formação e os que não integraram. Para tal foram realizados 2 estudos complementares. No estudo 1 foram entrevistados cinco especialistas portugueses de arbitragem de futebol, a partir de uma entrevista semiestruturada, com respetiva análise de conteúdo. No estudo 2 recolheram-se as classificações dos árbitros dos quadros nacionais de 2009-18 (N=243), tendo sido agrupadas de acordo com a sua formação: Grupo 1 (n=82) promovidos diretamente; Grupo 2 (n=86) promovidos de categorias após formação na AA; Grupo 3 (n=75) elementos que não foram promovidos. Os resultados do estudo 1 revelaram: i) uma mudança significativa na estruturação da formação dos árbitros portugueses a partir da época de 2013-14; ii) a existência de lacunas no processo formativo e classificativo; iii) a existência de uma cultura de individualismo e exigência no setor. Os resultados do estudo 2 apenas revelaram diferenças significativas entre o G3 e o G2. Conclui-se que foram percecionadas melhorias no processo de formação, embora não se verificaram melhorias significativas no desempenho classificativo. A variável experiência foi identificada como fator que influiu positivamente o desempenho classificativo.

Cannabis, Vulnerability, and the Onset of Schizophrenia: An Epidemiological Perspective

2000 ◽  
Vol 34 (3) ◽  
pp. 468-475 ◽  
Author(s):  
Martin Hambrecht ◽  
Heinz Häfner
Keyword(s):  
Structured Interview ◽  
Coping Resources ◽  
First Episode ◽  
Chronic Patients ◽  
Self Medication ◽  
Replication Studies ◽  
Cannabis Abuse ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: Second to alcohol, cannabis is the most frequently misused substance among patients with schizophrenia. The aim of this paper is to examine at early onset of psychosis whether the high comorbidity of schizophrenia and cannabis abuse is due to a causal relationship between the two disorders. Previous studies have mostly included chronic patients or samples with mixed stages of the psychotic illness. Method: In a German catchment area with a population of 1 500 000, a representative first-episode sample of 232 patients with schizophrenia was included in the Age, Beginning and Course of Schizophrenia Study. By means of a structured interview, the Retrospective Assessment of the Onset of Schizophrenia, the onset and course of schizophrenic symptoms and of substance abuse was systematically assessed retrospectively. Information given by relatives validated the patients' reports. Results: Thirteen per cent of the sample had a history of cannabis abuse, which was twice the rate of matched normal controls. Male sex and early symptom onset were major risk factors. While cannabis abuse almost always preceded the first positive symptoms of schizophrenia, the comparison of the onset of cannabis abuse and of the first (prodromal) symptoms of schizophrenia differentiated three approximately equal groups of patients: group 1 had been abusing cannabis for several years before the first signs of schizophrenia emerged, group 2 experienced the onset of both disorders within the same month, and group 3 had started to abuse cannabis after the onset of symptoms of schizophrenia. Conclusions: The vulnerability-stress-coping model of schizophrenia suggests possible interpretations of these findings. Group 1 might suffer from the chronic deteriorating influence of cannabis reducing the vulnerability threshold and/or coping resources. Group 2 consists of individuals which are already vulnerable to schizophrenia. Cannabis misuse then is the (dopaminergic) stress factor precipitating the onset of psychosis. Group 3 uses cannabis for self-medication against (or for coping with) symptoms of schizophrenia, particularly negative and depressive symptoms. These patients probably learn to counterbalance a hypodopaminergic prefrontal state by the dopaminergic effects of cannabis. The implications of these very preliminary results include issues of treatment and prognosis, but replication studies are needed.

Comparing cognitive functions in medication adherent and non-adherent patients with schizophrenia

2016 ◽  
Vol 33 (S1) ◽  
pp. S97-S98 ◽  
Author(s):  
A. El-Missiry
Keyword(s):  
Executive Functions ◽  
Verbal Memory ◽  
Visual Memory ◽  
Rating Scale ◽  
Memory Span ◽  
Digit Span ◽  
Wisconsin Card Sorting Test ◽  
Related Factors ◽  
Adult Intelligence Scale ◽  
Adherence To Medication

BackgroundMedication non-adherence presents a considerable problem in patients with schizophrenia. Cognitive and executive functions can affect adherence. The association between medication non-adherence and cognitive impairment in schizophrenia is under investigated with limited and conflicting research data.Purpose of the studyTo prospectively assess the rate of drug adherence among a sample of patients with schizophrenia and to compare the cognitive and executive functions between adherent and non-adherent patients.Subjects and methodsOne hundred and nine patients with schizophrenia diagnosed according to the DSM-IV classification were initially assessed by the Wechsler Adult Intelligence Scale (WAIS), Wechsler Memory Scale-Revised (WMS-R) and Wisconsin Card Sorting Test (WCST) and six months later by the Brief Adherence Rating Scale (BARS).ResultsAmong the patients, 68.8% were non-adherent to their antipsychotic medication. Adherent patients (31.2%) had significantly higher mean scores for the total, verbal and performance IQ. Moreover, they had significantly higher mean scores in most of WMS subtests (orientation, information, verbal paired association, digit span, visual memory span), and higher mean scores for; total correct, conceptual level response, percentage and categories completed on the WSCT subscales (P < 0.0001). Whereas the non-adherent group had higher mean scores in; trials administered, total errors, perseverative responses, and perseverative errors (P < 0.0001). In a step regression analysis, digit span, conceptualization, total and percentage of errors were putative predictors of non-adherence to antipsychotic medications.ConclusionCognitive deficits, especially verbal memory and executive functions were the strongest patients’ related factors associated with non-adherence to medication. Psychiatrists should consider possible cognitive factors influencing adherence to enable offering proper interventions.Disclosure of interestThe author has not supplied his declaration of competing interest.

scholarly journals The Treatment of Anxiety in Patients with Somatoform Dysfunction, Reaction to Severe Stress and other Neurotic Disorders: A Multicenter Double-blind Placebo-controlled Randomized Trial

2021 ◽  
Author(s):  
Vladimir Parfenov ◽  
Pavel Kamchatnov ◽  
Aleksandr Amelin ◽  
Evgeny Barantsevich ◽  
Dina Khasanova ◽  
...  
Keyword(s):  
Rating Scale ◽  
Depression Scale ◽  
Severe Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Neurotic Disorders ◽  
Group 3 ◽  
Anxiety Treatment ◽  
The Mean ◽  
Group 1

Abstract The existing treatment of somatoform dysfunction (SD), reaction to severe stress (RSS) and adjustment disorders (AjD) is insufficiently effective and safe. Anxiolytic drug Tenoten (Materia Medica Holding) is shown to be effective in clinical trials (CT). Objectives The aim of multicenter double-blind placebo-controlled randomized CT was to investigate the safety and efficacy of Tenoten in the anxiety treatment of adults with SD, RSS, AjD and other neurotic disorders (oNDs). Methods 390 adults with SD, RSS and AjD or oNDs with the Hospital Anxiety and Depression scale-anxiety (HADS-A) score≥11 were randomized into 4 groups (Tenoten group 14 tablets/day n=127; Tenoten group 3 8 tablets/day n=131, combined Placebo group 2+4 n= 132). The changes from baseline in the mean Hamilton Anxiety Rating Scale (HAM-A) score in groups 1 and 3 after 12 weeks was the primary outcome. Results The decrease in the HAM-A score from 18.81±5.81 to 7.26±4.63 (group 1) and from 18.38±4.3 to 6.40±4.02 (group 3) was observed post-treatment (p group 1/placebo =0.0055, p group 3/placebo <0.0001). The mean changes in the scores in the groups 1, 3 and the Placebo were 11.25, 11.91 and 9.71, respectively. In total, 46 AEs (28 AEs in the Tenoten groups, 18 in the Placebo) were registered in 37 patients (20 in the Tenoten groups, and 17 in the Placebo). No differences in frequency of AEs between groups were found. Conclusions Tenoten was shown to be significantly more effective than placebo in the anxiety treatment of adults with SD, RSS, AjD and oNDs (clinicaltrials.gov NCT03036293).

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