[Efficacy and safety of Cortexin as additional therapy in patients with depressive disorder]

To study the efficacy and safety of Cortexin as additional therapy in patients with depressive disorder.

The study involved 98 patients (56 women and 42 men) with a mean age of 44.0 (36.0; 52.0) years. They were divided into 2 groups: Group 1 (n=48) received basic antidepressant treatment plus intramuscular Cortexin at a dose of 10 mg once daily (in the morning) for 10 days; Group 2 (n=50) received only basic antidepressant treatment. During three visits (baseline, day 14, and day 28), the severity of depression and its dynamics were analyzed using the Montgomery-Åsberg Depression Rating Scale (MADRS), social functioning was assessed using the Social Adaptation Self-Evaluation Scale (SASS), treatment efficacy was evaluated using the Clinical Global Impression scale (CGI-I at weeks 2 and 4), and adverse events were recorded using the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale.

At visit 3, a significant reduction in depression severity (MADRS), an improvement in the quality of life of patients with depressive disorder (SASS), and a decrease in adverse events (UKU) were observed, with significant differences between the groups (p=0.001). By the end of the study, a significantly larger proportion of patients in the main group rated the improvement from therapy as «significant» and «substantial» (p=0.001).

The use of Cortexin as an additional therapy in patients with depressive disorder is effective and safe. Combined antidepressant therapy with Cortexin is superior to antidepressant monotherapy in terms of response rate and health-related quality of life. A more favorable safety profile was also demonstrated for the combination of antidepressants and Cortexin.