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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aalborg Psychiatric Hospital; Malmö University
• Treatments: Olanzapine; Sertindole

Criteria

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