For this a double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multinational multicenter clinical trial, OCT has initiated investigational sites in Russia and in Baltic States – 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.
This first patient has been screened a week ago, and was randomized in the study yesterday, while not a single patient has been screened by the sites out of OCT responsibility.
The primary objective of the trial 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.
The sampling size of 142 patients has been statistically confirmed to be sufficient to meet the objectives of the study and adequately assess the superiority of the tested drug over placebo.
After the first 50% (71) of patients complete treatment, interim analysis will be performed in order to evaluate the criteria to stop for futility or decide on the continuation of the trial.
This is not the first study in psychiatry in OCT statement of service. 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. Owing to such experience, OCT has formed good relationships with principal investigators in this indication - qualified psychiatrist with strong expertise who used to manage schizophrenic patients and according to national regulations, and hopes to proof to be the top-recruiter in this multinational clinical study.Slow enrollment rates in clinical sites and low quality of the services provided by the CRO are the main problems that any Sponsor may face while conducting a trial. Choosing the right partner is essential for the sponsors to reduce risks and secure themselves when conducting any clinical trial. OCT geography gives us a large pool of drug-naive patients in many therapeutic areas, which is the reason why often pharmaceutical and biotechnology companies address OCT with a request for a rescue study when speedy enrollment is needed in order to save the trial. The highly-qualified and skilled OCT clinical team can always quickly analyze the situation and work out options to improve it.