This will be a double-blind, placebo-controlled, randomized multicenter phase II clinical study to assess safety and efficiency of the investigational drug which is nasal drops in patients with adjustment disorder with anxiety.
The main objective of this clinical trial is to prove therapeutic effect in respect to the changes in the patient’s condition at the end of the study in comparison to the beginning of therapy.
The study’s additional objectives include comparison of the efficiency of the investigational nasal drops in comparison to placebo against the CGI-I scale, and against the Sheehan Disability Scale (SDS), as well as assessment of the pharmacokinetic parameters and the safety of the drug under investigation.
Adaptive design of the current study presupposes that all the initially included patients will go through the introductory course of placebo treatment in order to exclude those patients who are responsive to placebo.
Thus, the study will include 233 patients diagnosed with adjustment disorder with predominance of anxiety symptoms, 198 of which will be randomized into the four therapy groups.
For this study, OCT is providing full support starting from preparation of the Study Essential Documents (Study Protocol, Investigators’ Brochure, Informed Consent Form, Case Report Form, Monitoring and other study manuals) and submission of the package of documents to the ministry of Healthcare of the Russian Federation in order to obtain approval for the study conduct, to project management, clinical monitoring, data management and statistics.
OCT has serious expertise in conducting clinical trials in a huge number of therapeutic areas, and CNS and psychiatry diseases are not an exception. Owing to the years of collaboration with a number of medicinal centers all over Russia and other countries of OCT operation (Ukraine, Belarus, Baltic States, Bulgaria, Georgia, Germany and the United States), OCT has a data base of medicinal sites which will ensure timely enrollment of patients with adjustment disorder with anxiety for the described study.
In addition to that, OCT has been cooperating with a variety of bioanalytical laboratories in different countries, and is always able to choose the most efficient partner in terms of both geographical location and costs for conducting different kinds of analysis, including pharmacokinetic tests. All the vendors involved in OCT projects undergo audits in order to ensure compliance with both local and international standards and the high quality of services provided.