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

University of Aarhus

Status

Terminated

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Drug: Sertindole

Study type

Interventional

Funder types

Other

Identifiers

NCT00885690

3.1 - 01-25-09

Eudra CT nr: 2008-008366-13

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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