Efficacy of a Relaxation Scenario in Virtual Reality for the Comorbid Symptoms of Anxiety and Asthenia in a General Hospital Setting: A Pilot Comparative Randomized Open-Label Study.

BACKGROUND: Patients in general hospitals often display concomitant signs of mental maladjustment: low mood, anxiety, apathy, asthenia, all of which can have a negative impact on the course of the underlying disease and the recovery process. One of the non-pharmacological approaches that has gained wider acceptance in medical practice in recent years is the use of procedures based on virtual reality. AIM: Assess the efficacy of the new domestic, virtual reality application Flow as relates to symptoms of anxiety and asthenia in patients undergoing inpatient treatment. METHODS: The study was open-label and had a comparison group; the patients were assigned to the experimental or control group using a randomization table. The patients were assessed using the Spielberger State Anxiety Inventory; the Fatigue Symptom Rating Scale; the Well-being, Activity, Mood questionnaire; the Depression Anxiety Stress Scale; and the Clinical Global Impression Scale. Physical parameters were measured before and after each virtual reality session. The obtained data were statistically processed. RESULTS: The study involved 60 patients. In 40 patients, the treatment program included a course of five daily relaxation sessions in virtual reality; the control group consisted of 20 patients, who were treated in accordance with the usual practice of the institution. The addition of virtual reality sessions to the standard treatment course yielded significant advantage in terms of affective symptoms reduction in patients both after a single session and as a result of undergoing the full course, and several days after its completion. The patients in the experimental group also showed a significant decrease in blood pressure after the sessions, and this was most pronounced in individuals who initially had elevated and high blood pressure. CONCLUSION: The use of relaxation program courses in the virtual reality application Flow is an effective and promising means of non-pharmacological care for non-psychiatric inpatients showing symptoms of anxiety, apathy, depressive mood, as well as hypertension.

Treatment Response and GWAS Risk Allele rs2514218 (C) of the Dopamine D2 Receptor Gene in Inpatients with Schizophrenia.

INTRODUCTION: The pathophysiological mechanisms of acute schizophrenia are largely unknown, but it is widely accepted that dopamine D2 receptors (DRD2s) are involved in psychosis treatments for schizophrenic patients. We suggest that genetic variation in these receptors may play a role in patients' responses to commonly used antipsychotics, particularly D2-blockers. METHODS: This study included adult patients with ICD-10 diagnoses of schizophrenia and current acute psychosis who were treated with antipsychotics. All patients underwent genotyping for DRD2 rs2514218 polymorphism. The definition of overall treatment response was based on changes in treatment scheme: no changes indicated a good response, and changes indicated a limited response. RESULTS: There were 275 inpatients (38.1% of whom were female; mean age = 32.7 years, SD = 11.1 years) who met the inclusion criteria. Of the participants, 99 were good responders (34% of whom were female), and 176 were limited responders (40% of whom were female). No differences in demographic, premorbid, or disease characteristics were found. The number of patients that were homozygous for the risk allele was significantly greater in the limited response group than in the good response group. CONCLUSION: Our findings suggest that the risk variant at the DRD2 locus can be used as an indicator for patients' responses to antipsychotics without direct DRD2-blocking, thereby shortening the time needed for drug selection.

Safety and efficacy of aviandr in patients with generalized anxiety disorder: A multicenter, randomized, double-blind, placebo-controlled, dose-finding, pilot study.

Generalized anxiety disorder (GAD) is associated with an imbalance in the functioning of the stimulating neurotransmitter systems in human's brain. We studied the safety and therapeutic efficacy of aviandr, the new noradrenergic and specific serotonergic antidepressant, for GAD patients in the phase II, double-blind, placebo-controlled, randomized, multicenter, pilot trial at 17 clinical sites of the Russian Federation. 129 eligible patients were 18 years and older and met the criteria for GAD diagnosis. The patients were randomly assigned (1:1:1) to receive oral aviandr at daily dose of 40 mg (cohort 1, n = 41) or 60 mg (cohort 2, n = 43) or placebo (cohort 3, n = 43) for 8 weeks. The patients were assessed by the Hamilton anxiety scale (HAM-A), Hamilton Depression Scale (HAM-D), Clinical Global Impression Scale (CGI-S), Visual Analogue Scale and vital signs. At week 8, the decreases of the HAM-A score were achieved in 53∙7%, 47∙7% and 16∙3% in cohorts 1, 2 and 3, respectively. Changes of HAM-A, HAM-D, CGI-S, and CGI-I scores in aviandr-treated patients were superior to placebo (p < 0∙001). The psychic components of anxiety decreased on the first day, throughout the 8 weeks of treatment and on a follow-up week after aviandr discontinuation. Aviandr (40 mg daily dose) reduced drowsiness compared to baseline, was safe, well-tolerated and did not cause serious or severe adverse events or signs of withdrawal syndrome within one week after treatment completion. Aviandr at both 40 and 60 mg daily doses demonstrated therapeutic efficacy in GAD patients over placebo.

Validation of the Russian Version of the Positive and Negative Syndrome Scale (PANSS-Ru) and Normative Data.

Objective: The Positive and Negative Syndrome Scale (PANSS) is widely used to assess psychopathology. The Russian version (PANSSRu) has not been validated, and normative data for the Russian-speaking population currently do not exist. The aims of this study were to 1) complete linguistic validation for the PANSSRu, 2) perform psychometric validation of the Russian translation, and 3) present norms for the Russian and Belarusian population. Design: Validation and norms of the PANSS-Ru occurred in three stages-Stage I: linguistic validation; Stage II: psychometric validation of the translated version for 40 inpatients with schizophrenia and other psychoses; and Stage III: norms for 533 census-matched inpatients, outpatients, and healthy control subjects. Results: The rating criteria (PANSS-Ru), interview guide (SCI-PANSSRu), informant questionnaire (IQ-PANSS-Ru), and scoring form (PANSS QuikScore-Ru) were linguistically and psychometrically validated. Convergent validity between the PANSS subscale scores and total score with the Clinical Global Impressions-Severity Scale (CGI-S) were moderate (r=0.41-0.60) to high (r=0.61-0.80). Cronbach's α (0.88) verified internal consistency, and intra-class correlation coefficient (ICC) comparisons had a range of 0.83. Percentile normative data collected from 533 subjects are presented. Conclusion: This is the largest population-based study providing linguistic and psychometric validation of the PANSS-Ru. Normative data can provide clinicians with a benchmark of psychopathology and inform the efficacy of treatment interventions.

5-HT6 Receptor Antagonist as an Adjunct Treatment Targeting Residual Symptoms in Patients With Schizophrenia: Unexpected Sex-Related Effects (Double-Blind Placebo-Controlled Trial).

BACKGROUND: Treating patients who experience residual psychotic symptoms during remission of schizophrenia remains one of the most challenging problems. The mechanisms underlying these symptoms differ from those of acute hallucinations and delusions. 5-HT6 receptor antagonists have been considered promising agents in treatment of residual psychotic symptoms and cognitive dysfunction. The aim of the study was to assess the efficacy of a selective 5-HT6 inhibitor Avisetron in the reduction of residual psychotic symptoms in patients with schizophrenia on stable antipsychotic therapy. METHODS: Eighty clinically stable outpatient subjects with schizophrenia with residual psychotic symptoms were randomized in a double-blind manner to 6 weeks of Avisetron or placebo at 1:1 ratio. Subjects received 8 mg of Avisetron or placebo on top their stable antipsychotic treatment. Standard clinical scales and cognitive tests were used for endpoint assessment. The primary efficacy endpoint was the mean reduction of total Positive and Negative Syndrome Scale score after 6 weeks of treatment. RESULTS: No significant differences in the primary and secondary endpoints were found between the groups. However, based on the subgroup analysis, the significant improvement of total Positive and Negative Syndrome Scale score and residual psychotic symptoms was observed in female patients. CONCLUSIONS: It was a negative study with unexpected benefits of the drug only in females. We hypothesized that the role of patients' sex can impact the treatment response to serotonergic drugs in general. We suggest a possible synergistic interaction between estrogen and Avisetron by means of modulating the effect of estrogens on the serotonergic system. Future studies targeting the sex-related effects of serotonergic drugs are warranted.