This is a multinational, randomized, double-blind, placebo-controlled, parallel-groups, fixed-dose design and multicenter study conducted in France, Latvia, Romania, Hungary and Russia.
The primary objective of this study is to evaluate the potential efficacy of the study treatment in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. The secondary objectives include the assessment of safety of the tested product and description of its pharmacokinetics.
After completion of the interim analysis in August 2015 a decision was made to continue the ongoing clinical trial.
It is expected that Latvian and Russian sites will resume their activities by the end of September; it is also expected that additional sites will be opened in Russia by that time. Currently, one site in Latvia and another one in Russia have resumed their participation in the study with the first patient enrolled on August 26 in the Russian investigational site.
This is far not the first clinical trial in psychiatry successfully conducted by OCT team. Seven studies in this filed have been conducted by OCT for the last three years, among which three studies were in patients with schizophrenia. Owing to our expertise, we have managed to build up long-term and strong relationships with principal investigators in this area.
We understand that choosing the right partner is crucial and requires great care. Our clients may rely on us and feel more confident knowing that all associated risks are minimized. With its extensive national and international presence OCT provides its partners with high enrollment rates for clinical trials in variety of therapeutic areas. Our team of clinical experts always keen to provide a quick project analysis on an individual basis and to develop a strategy unique to your goals and objectives.