The current study is a double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicenter clinical trial.
The primary objective of this study is to evaluate the potential efficacy of the investigational drug in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Secondary objectives include assessment of safety of the tested product and the genotype-efficacy relationship, as well as description of its pharmacokinetics of the product.
Taking into consideration the objective of the study and the proof of concept design, the study sample size with 142 included patients is considered sufficient to adequately assess the superiority of the tested drug over placebo.
The study design implicates that interim analysis will be performed on the first 50% (71) of patients having completed the study in order to evaluate the criteria to stop for futility and decide on the continuation of the trial.
All patients will be recruited by multiple centres by qualified psychiatrist who used to manage schizophrenic patients and according to national regulations.
About 29 centres in about 6 countries (France, Hungary, Romania, Lithuania, Latvia, Russia) will be involved in the study. OCT is responsible for the three countries from the list: Russia, Latvia and Lithuania. Study documents were prepared and reviewed, and regulatory submissions have been made in the Ministries of Healthcare of the listed countries, and now we are awaiting approvals from the regulatory bodies.
OCT has in-depth experience in psychiatry studies: 7 studies have been conducted by our team within the last three years, and 6 of those were phase II studies, three of those were in patients with schizophrenia.
Schizophrenia is a chronic, debilitating psychiatric disorder affecting between 0.5% and 1.1% of adults worldwide. Several illness characteristics contribute to the substantial personal and socioeconomic burden imposed by schizophrenia, including onset in early adulthood, the persistence of symptoms despite treatment, and the disabling nature of those symptoms, which 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 studies (an international world-wide known pharmaceutical company) will help find safe but effective treatment for patients suffering from this serious disease.