The Sertindole Cohort Prospective (SCoP) study: rationale, design and methodology

Area of Science:

• Pharmacology
• Clinical Trials
• Psychiatry

Background:

• Antipsychotic medications are crucial for schizophrenia management.
• Assessing real-world drug safety is essential for clinical decision-making.
• Sertindole's safety profile requires thorough investigation under typical usage conditions.

Purpose of the Study:

• To outline the rationale and methodology of the Sertindole Cohort Prospective (SCoP) study.
• To evaluate the safety of sertindole in schizophrenia patients during routine clinical practice.
• To compare sertindole's safety against risperidone, a common antipsychotic.

Main Methods:

• Prospective, randomized, partially blinded, active-controlled, multinational trial design.
• Inclusion criteria were broad to maximize external validity and real-world applicability.
• Primary endpoints included all-cause mortality and hospitalization for arrhythmia; secondary endpoints covered various safety events.

Main Results:

• The study design focused on collecting high-quality data for safety evaluation.
• A total of 3800 person-years of exposure in each arm was required for 80% power.
• This represents one of the largest post-authorization studies in schizophrenia research.

Conclusions:

• Naturalistic safety data are vital for prescribing antipsychotics.
• The SCoP study's prospective, randomized, and controlled design ensures robust 'real-world' safety evaluation of sertindole.
• High-quality data collection under normal conditions of use supports informed clinical practice.