The approval has been received in the framework of double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multinational multicenter clinical trial that has been started last summer.
6 countries including France, Hungary, Romania, Lithuania, Latvia and Russia have been involved in the study. OCT is responsible for the three countries from the list: Russia, Latvia and Lithuania. Medical centers in three more countries (France, Hungary and Romania) are managed by Sponsor which is a world-wide known international pharmaceutical company.
Because of the fact that the regulatory timelines are a bit shorter in Baltic States in comparison with Russia (60 days to get an approval for a clinical study conduct in Latvia and Lithuania versus 90 days in Russia), medical sites in Baltic States have already been initiated and the first patients was randomized into the study late august 2014.
Now that the approval to conduct this study in Russia has been obtained, once the selected medical sites will be initiated, patients’ enrollment will start in Russia and the total number of 142 patients suffering from schizophrenia will be included into the study in good time.
Schizophrenia is a chronic psychiatric disorder affecting between 0.5% and 1.1% of adults worldwide. The main characteristics of this illness such as onset in early adulthood, the persistence of symptoms despite treatment, and the disabling nature of those symptoms, often impair patients’ social and vocational functioning, including the ability to live independently. Although improvement is noted over time for some patients, the majority of patients experience at least some persisting symptoms despite treatment. Research and investigations conducted by the Sponsor of the described study will help find safe but effective treatment for patients suffering from this serious disease.
This is not the first study in psychiatry in OCT proven track record. Seven studies in this therapeutic area have been conducted by OCT team within the last three years, and 3 of those were in patients with schizophrenia. As a result of such experience, OCT has formed good relationships with principal investigators in this indication - qualified psychiatrists with strong expertise who used to manage schizophrenic patients according to national regulations, and we hope to proof to be the top-recruiter in this multinational clinical study.