The prevalence and incidence of mood disorders is projected to rise globally presenting significant health, social and economic consequences.

The ICON CNS-focused Global Site Network includes 22 psychiatry experienced sites, located across the globe with a proven track-record of studies in mood disorders, ensuring a rapid start-up, access to patients and a competent study execution.

Managing adherence to experimental treatment

Poor compliance to medication is a major risk for a failed study in psychiatric disorders. ICON established a set of cost-effective measures, ranging from informative MedicPlans for patients and caregivers, dispensing aids and regular and customised reminders to intermittent pharmacokinetic sampling. ICON also utlises various advanced technical solutions such as face recognition software, blisters and boxes with detectors to capture when medication is used and additto study medication for more meaningful pharmacokinetic (PK) analysis.

Managing placebo response

ICON has developed a unique set of materials to address the key drivers for placebo responses; patient expectations, baseline bias/inflation, and rating inconsistencies. This includes site training materials for site staff, a patient e-workbook, data analytics to manage baseline inflation, and integration of more objective endpoints which are indirectly linked to pain, for inter-scale plausibility assessment. See brochure below for more details.

ICON clinical experience in last five years

  • 50+

    Mood disorder clinical studies
  • 22,300

    Patients involved
  • 3,381

    Sites worldwide

Endpoint quality strategies

ICON has all relevant services for wet, imaging and digital biomarker endpoints in house.

ICON is the leading sponsor of Mapi Research Trust, a non-profit organization and license holder of the largest repository of Clinical Outcomes Assessments (COA) globally (4,360 COAs ) with over 400 scales relevant for the schizophrenia, depression and biploar disorder.. A subset of 143 of these scales are implemented in our electronic clinical database for immediate use: 77 in major depressive disorder, 45 in Schizophrenia and 21 in bipolar disorder.

As the license holder of some of the most commonly used scales in these indications, ICON can achieve optimised start up timelines as that step is removed from the critical path. We support the design or re-validation of scales wherever needed, also to create more patient-relevant outcomes to address authority expectations.