Psychiatry Clinical Trials: Therapeutic Expertise in Psychiatric Disorders

Worldwide Clinical Trials operational staff and clinical assessment teams are exceptionally familiar with the use of appropriate diagnostic and outcome measures to evaluate a variety of psychiatric disorders. We have worked with various proprietary and commercial rater response systems and have utilized several systems in our psychiatry clinical trials to assess rater agreement with patients’ self reports on various scales, including the SCID-CT, MINI, HAM-D, YMRS, MADRS, BPRS, and PANSS. We also recognize the importance of choosing the appropriate assessment battery to measure cognitive deficits in CNS disorders and the correct application of test instruments when assessing cognition in psychiatric disorders such as schizophrenia. Worldwide teams have extensive experience working with the CANTAB, CogState, and CDR computerized cognitive batteries (among others) on numerous psychiatric trials.

Our Strengths in Psychiatric Studies Include:

  • Extensive experience and expertise across various psychiatric disorders
  • Experience in conducting clinical trials in psychiatry with >4,200 patients enrolled since 2008
  • Established network of over 100 highly qualified investigators
  • State-of-the-art international rater training and clinical assessment team
  • Exceptional operational capabilities in the Central and Eastern Europe, with outstanding enrollment/retention metrics in the region
  • Expertise in medical aspects and outcome measures most widely utilized in psychiatryic clinical trials

Operational Excellence in Emerging Regions for Psychiatric Studies

Central and Eastern Europe have a long tradition of successfully conducting psychiatric research studies. This region has an established network of highly qualified psychiatrists and has a large number of psychiatric patients available across disease stages, as well as unprecedented access to an untapped pool of treatment-naïve patients eager to enroll in psychiatry clinical studies. Given the unique treatment practices, sites in this region often boast very high enrollment numbers with exceptionally low attrition rates of less than 5% (even in bipolar and schizophrenia outpatient studies where attrition rates have exceeded 50% in western countries).

Recent data from our clinical assessment team shows that Principal Investigator (PI) raters from this region have similar measures of dispersion and bias from gold standards as their western counterparts, suggesting highly capable site raters. Another unique characteristic of conducting clinical trials in psychiatry in this region is the fact that the majority of Worldwide Clinical Trials CRAs working in the CEE region are medical doctors and have positive relationships with investigative sites.

Indication Experience in Psychiatry

  • Addiction/Drug Dependencies
  • Attention Deficit Hyperactivity Disorder (pediatric and adult)
  • Bipolar Disorders
  • Generalized Anxiety Disorder
  • Major Depressive Disorder
  • Mixed Depression
  • Schizophrenia (acute, chronic, negative symptoms, cognition)
  • Smoking Cessation