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

University of Aarhus2 sites in 2 countries11 target enrollmentApril 2009

ConditionsSchizophrenia

InterventionsSertindole Olanzapine

DrugsSertindole Olanzapine

Overview

Phase: Not Applicable
Intervention: Sertindole
Conditions: Schizophrenia
Sponsor: University of Aarhus
Enrollment: 11
Locations: 2
Primary Endpoint: CANTAB cognitive test battery
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

November 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•AnICD-10 schizophrenia diagnosis F20.0-F20.
•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

Arms & Interventions

Sertindole

Sertindole 16-24 mg

Intervention: Sertindole

Olanzapine

Olanzapine 10-20 mg

Intervention: Olanzapine

Outcomes

Primary Outcomes

CANTAB cognitive test battery

Time Frame: Baseline - 6 and 12 weeks

Secondary Outcomes

Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure(Baseline - 6 and 12 weeks)
PANSS, CGI, Sf-36 (quality of life), GAF (social function), UKU (side effects), DAI (attitude towards medicine), Beck's insight scale, Specific Level of Functioning (SLOF)(Baseline, 6 and 12 weeks)