The study was carried out in 28 clinical centers of Russia. The data on 728 patients with psychoautonomic syndrome (91.6% of the total sample) were available for statistical analysis. All patients suffered from asthenic disorders. The
duration of treatment with
ladasten in daily dose from 50 to 100 mg was 28 days. Patient's state was assessed with psychometric scales at baseline, 3, 7, 14 and 28 days of
therapy and one month after the end of treatment. The percentage of responders was 76.0% on the CGI-S and 90.8% on the CGI-I. The antiasthenic effect of
ladasten was seen on day 3 and remained during one month after the withdrawal of
therapy. We determined clinical efficacy of
ladasten in regard to anxiety-depressive spectrum disorders, autonomic
dystonia,
sleep disorders.
Ladasten therapy led to the significant increase of quality of life, which was seen not only after the end of
therapy, but after the withdrawal of the
drug. These results suggest the stability of the
therapeutic effect achieved. Adverse effects were observed only in 3% of patients, the
therapy was discontinued in 0.8%. No serious adverse effects were found. In conclusion, the efficacy of
ladasten was shown in its antiasthenic, anxyolytic, autonomic nervous system stabilizing properties, the normalization of sleep-awake cycle and the increase of quality of life.
Ladasten in daily dose from 50 to 100 mg is a highly effective, well-tolerated and safety
drug with a wide spectrum of clinical effects. Therefore, this
drug could be recommended for treatment of asthenic disorders in neurological practice.