[The peptide analogue of neurotensin with antipsychotic and pro-cognitive effects: results of the pilot clinical trial]. / Peptidnyi analog neirotenzina s antipsikhoticheskimi i prokognitivnymi svoistvami: rezul'taty pilotnogo klinicheskogo issledovaniia.

OBJECTIVE: To evaluate the psychotropic specific spectrum activity of the novel peptide drug dilept and to find its effective doses in patients with schizotypal disorder. MATERIAL AND METHODS: The effects of dilept were studied in 25 patients (33.4±10.0 years old) with schizotypal disorder (F21.3) with predominance of obsessive-compulsive, hypochondriac, phobic symptoms, mild cognitive impairment and negative symptoms. Patients were treated with dilept 60, 120 and 200 mg daily for 14 days as monotherapy (with allowance of phenazepam up to 2 mg single doses for insomnia and anxiety) followed by combined treatment with phenazepam in the case of insufficient effectiveness of dilept monotherapy. The Positive and Negative Syndrome scale (PANSS), Psychopathological Symptom Severity scale, Clinical Global Impression scale (CGI) and Wechsler Adult Intelligence scale (WAIS-R) were used as outcome measures. RESULTS AND CONCLUSION: Dilept demonstrated the unique spectrum of psychotropic activity: antipsychotic with stimulating action, favorable effect on negative symptoms and cognitive dysfunction. Treatment action was the most evident when dilept was used in the dose 200 mg/day. There was no evidence of any side-effects known to be typical for antipsychotics. The efficacy of dilept and phenazepam combination is dependent on dilept's antipsychotic and pro-cognitive effects, while benzodiazepine lacks these effects.

[Results of a clinical study of a new anxiolytic, a blocker of central cholecystokinin receptors]. / Rezul'taty klinicheskogo issledovaniia novogo anksiolitika, blokatora tsentral'nykh kholetsistokininovykh retseptorov.

AIM: To evaluate anxiolytic action of GB-115, a low-affinity blocker of central cholecystokinin receptors, used in tablets in a dose of 1 mg for the treatment of patients with anxiety disorders in order to determine effective dose, safety, tolerability and efficacy in clinical settings. MATERIAL AND METHODS: The study included 31 patients (22 women, 9 men) diagnosed with generalized anxiety disorder (GAD, F41.1 according to ICD-10), aged from 22 to 53 years. The duration of treatment was 21 days. The Hamilton Anxiety Rating scale, Psychopathologic symptoms severity evaluation scale (PSSES), Spilberger State-Anxiety Inventory, Multidimensional Fatigue Inventory (MFI), Clinical Global Impression scale (CGI), computerized battery for evaluation of cognitive functions ('NS-Psychotest') were used. RESULTS AND CONCLUSION: The effective dose of GB-115 was determined at 6 mg per day. Drug action is characterized by fast onset of anxiolytic effect with stimulating properties and beneficial effect on sleep disturbances and autonomic symptoms. GB-115 treatment was associated with favorable changes in attention parameters, reaction time and overall performance. In contrast to first-line drugs for GAD treatment (SSRIs and SNRIs), GB-115 does not induce initial overactivation, anxiety and sleep disturbances. GB-115 is safe and has a good tolerability.

[Cognitive processes in patients with different structure of anxiety disorders]. / Osobennosti kognitivnykh protsessov u bol'nykh s razlichnoi strukturoi trevozhnykh rasstroistv.

AIM: To study the relationship between cognitive functions and psychopathological disturbances in anxiety disorders. MATERIAL AND METHODS: WAIS, the modified Witkin's Embedded figures test, a symptom scale (Yu.A. Aleksandrovsky et al. 1984) were administered to 111 patients, including 37 with generalized anxiety disorders (GAD, ICD-10 F41.1), 36 with anxiety-phobic disorders (AFD, ICD-10 F40) and 38 with anxiety-hypochondriac disorders (AHD, ICD-10 F45.2), and to 114 healthy people. RESULTS AND CONCLUSION: A distinct trend towards an increase of cognitive impairment depending on an increase in the complicity of psychopathological picture was observed as follows: GAD - AFD - AHD. A decrease in visual-motor coordination and visual attention was found in patients with GAD. In AFD patients, besides disturbances characteristic of GAD, there was a decrease on the WAIS Vocabulary subtest. In AHD patients, there was a decrease in analytic and synthetic abilities. The heterogeneity of changes in cognitive processes and the structure of their correlations with psychopathological symptoms in anxiety disorders was revealed as follows: a decrease in some parameters of cognitive processes in anxiety disorders with mild structure, an increase in cognitive dysfunction and in a number of correlations in anxiety disorders with more complex psychopathological picture, higher scores on the WAIS Block design task.

[Effect of phenazepam in various medicinal forms on psychophysical state of patients with anxiety disorders].

Differences between phenazepam formulations were found in the clinical study of drug effects on the psychophysiological state in patients with anxiety disorder. Phenazepam did not cause negative changes of psychophysiological parameters. In patients with anxiety disorders, the most significant positive therapeutic actionon psychophysiological state was observed in the case of using transdermal phenazepam formulation.

[Self-evaluation of single test doses and objective indices of ladasten vs. placebo efficacy in neurasthenic patients].

Self-evaluation of the effect of single-dose (15 mg) ladasten administration versus placebo has been studied in patients with neurasthenia diagnosis. Relationships between self-evaluation parameters and personal features, psychopathological and psychophysiological parameters of patients, drug action characteristics, and course treatment effectiveness have been analyzed. Results suggest that the self-rated high tolerability of ladasten treatment is comparable with that of placebo. No relationships are found between the self-evaluated single-dose effects of ladasten and personal features of patients. Correlations of the self-estimations and some psychopathological and psychophysiological parameters before treatment, main drug effects, and overall course treatment effectiveness are revealed, whereas the self-evaluation of placebo effect was related to personal features.

[Ladasten, the new drug with psychostimulant and anxiolytic actions in treatment of neurasthenia (results of the comparative clinical study with placebo)].

An aim of a randomized blind study was to assess therapeutic efficacy and safety of ladasten used as an antiastenic drug in patients with neurasthenia. Tasks of the study included the investigation of characteristics of therapeutical actions, efficacy of the drug comparing to placebo, possible side-effects and probability of the development of "withdrawal syndromes". The design of the study included a wash-out period, a monotherapy with ladasten and placebo during 28 days and a final 1-week period of receiving placebo. Standartisized objective and subjective methods of mental state evaluation in patients were administered. The results obtained suggest that a combination of psychostimulant and anxiolytic actions in the spectrum of psychotropic activity of ladasten determines the its high therapeutic efficacy in asthenic disorders. It has been found that ladasten is superior in the rate and degree of reduction of main symptoms of asthenic syndrome compared to placebo. The absence of "withdrawal syndrome" after the drug withdrawal reveals the lack of addictive potential in this drug.

[Therapeutic effect and pharmacokinetics of transdermal phenazepam preparation in patients with different anxiety disorders].

Clinical investigation of a transdermal phenazepam preparation (phenapercuten) in patients diagnosed with different anxiety disorders revealed an original therapeutic action of the new drug, which included both a selective anxiolytic effect and an activating (antiasthenic) component in the absence of undesired sedative and miorelaxant properties. It is shown that the specific action of phenapercuten is related to features of the pharmacokinetic profile of this transdermal drug that is characterized by a low levels of active compound in the blood plasma and by the absence of peak concentrations. TTS Phenapercuten was most effective in patients with anxiety disorders of simple structure.

[Therapeutic action and efficiency of fevarin (fluvoxamine) in patients with non-psychotic anxious and apathic-adynamic depressions]. / Terapevticheskoe deistvie i éffektivnost' fevarina (fluvoksamina) u bol'nykh s nepsikhicheskimi trevozhnymi i apatoadinamicheskimi depressiiami.

10 patients with anxious and 10 patients with apathic-adynamic depressions were treated with fevarin. The efficiency of the drug and its influence on the psychopathologic structure were evaluated according to some scales. It was established that therapeutic action of fevarin manifests from the 1st week of therapy in patients with anxious depressions due to its anxiolytic properties. In apathic-adynamic depressions the reduction of the symptoms was revealed by the 3-4 week of the therapy. The antidepressive effect of fevarin was retarded and didn't depend on the structure of the depression. Higher efficiency of the drug in patients with anxious depressions was explained by combination of thymoanaleptic and anxiolytic effects. The results of the study demonstrate a perspective of fevarin in therapy of anxious and apathic-adynamic depressions.