Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)

A Multicentre Double-blinded Randomized Head-to-head Study

Cognition is one of the core symptoms of schizophrenia. This study is a head-to-head trial between olanzapine and sertindole with cognition as primary outcome. The design is a 12-week double-blinded randomized controlled flexible dose study.

Inclusion Criteria:

• AnICD-10 schizophrenia diagnosis F20.0-F20.9.
• Contraception.
• A negative pregnancy test for women.
• No known allergy to any of the substances in the study medication
• Baseline QTc < 450 milliseconds for men and < 470 milliseconds for women
• S-potassium and s-magnesium within normal reference range.
• Suboptimally treated on current antipsychotic medication
• Stable dosage of antidepressants and mood stabilizers one month before the inclusion
• Signed informed consent and power of attorney

Exclusion Criteria:

• Withdrawal of consent
• QTc prolongation >500 milliseconds during the study
• Patients with known clinical important cardiovascular disease
• Significant substance abuse
• Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine.
• Calgary Depression Scale score ≥ 7
• Treatment that interferes with the metabolism of sertindole or olanzapine,
• Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing
• Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period
• Treatment with an anticholinergic after the first three weeks of the study
• Somatic illness, as judged by investigator, interfering with cognition
• Known risk of narrow angle glaucoma
• Treatment with electroconvulsive therapy (ECT) the last three months before inclusion, or treatment with ECT in the study period
• Treatment with clozapine or depot antipsychotics before inclusion