25.Jan.2016

Clinical study in patients with acute exacerbation of schizophrenia completed

This was a multinational, multicentre, double-blind, placebo-controlled, randomized study conducted in Latvia, Russia, Hungary and Romania.

The primary objective of this study was 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 included the assessment of safety of the investigated product and description of its pharmacokinetics.

OCT was responsible for conducting this study in Latvia and Russia. Patients were enrolled within 2 periods. OCT has randomized over 60 patients in total, 11 patients were not included in the trial after the screening.

Country # of sites Patients
randomized
Romania 13 48
Russia 10 45
Hungary 6 13
Latvia 3 17

Latvian investigational sites were the first ones to start the enrollment in August 2014. Russian investigational sites were included into the study in March 2015 and managed to randomize 23 patients within 5 weeks. Therefore, about 58% of patients were randomized in Russia and Latvia during the first enrollment period. In August 2015, after completion of the interim analysis, the second period of enrollment started. The average enrollment rate in Russia and Latvia was 5-10 patients per month. The enrollment was completed one month earlier than it was initially expected.

This is not the first clinical trial in psychiatry successfully conducted by OCT team. For the last three years OCT conducted seven studies in this field (among which three studies were in patients with schizophrenia). Such clinical trials (especially placebo-controlled ones in patients with exacerbation) are always subjected to detailed ethical and pharmacological review prior to submission of applications for their approval. An appropriate justification of the study and a full set of documents is a cornerstone of a successful regulatory submission. OCT can guarantee that due to its sound expertise.

With its extensive national and international presence OCT provides its partners with high enrollment rate for clinical trials in a variety of therapeutic areas. Our team of clinical experts are always keen to provide a quick project analysis on an individual basis and to develop a unique strategy that meets your goals and objectives.