The purpose of this open trial ...

The purpose of this open study conducted in the department for the study of borderline mental diseases and psychosomatic disorders (Director - academician of RAMS, Professor AB Smulevich) SCMH RAMS - efficacy and safety Pirazidola (Release preparation renewed by the domestic industry in 2002 necessary to conduct a study of Pirazidola courtesy JSC Masterlek. ") in depressive states. Materials and methods Selection of patients in the study was conducted taking into account the overall prediction efficiency of antidepressant therapy, according to which the relief of mood disorders substantial severity (severe depression) are preferred methods of intensive treatment with antidepressants of tri-and heterocyclic structures [11,14,20]. Respectively, of a sample formed of the number of patients coming of age (18-60 years) with non-psychotic depression levels (mild to moderate severity). Inclusion criteria: • Compliance of the clinical picture of the observed disorder diagnostic criteria for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33); · severity of depression in a formalized evaluation of at least 16 points on the Hamilton scale (HDRS-21); · informed consent to participate in the study; · adequate methods of contraception for women of childbearing age. Excluded were patients with evidence of organic CNS lesions, severe systemic diseases, abnormalities in laboratory tests, a high risk of suicide, substance abuse. Dominant disorder in the sample (30 patients - 24 women and 5 men, mean age 39 ± 4,1 years) were recurrent depression of moderate severity (21 observation - 70% of patients, constituting the sample). The duration of this disorder at the time of the survey ranged from 1 to 8 months. Therapy Pirazidolom conducted on a flexible technique, involving the appointment of treatment regimens and therapeutic doses of the drug in accordance with the structure of psychopathology, severity of symptoms and the specific dynamics of the observed affective disorder. The initial dose was 50-75 mg / day, mean daily - 200-350 mg, and distributed into 2 doses (in the evening hours due to the risk of insomnia Pirazidol not appointed). The course of treatment Pirazidolom was for all patients 28 days - 4 weeks of active therapy. In cases of insomnia permitted the use of benzodiazepine anxiolytics (phenazepam to 3 mg / day, clonazepam - up to 2 mg / day, alprazolam - up to 1 mg / day). To evaluate the efficacy and safety of therapy used the following tools: Scale Clinical Global Impression (CGI), Hamilton Scale for Depression Rating (HDRS-21), scale evaluation of side effects (UKU). The therapeutic effect was assessed as positive when registering expressed or substantial improvement on the scale of CGI, as well as reducing the amount of points on the scale of Hamilton for more than 50% compared with baseline values.