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

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Sertindole; Drug: Olanzapine

• Registration Number: NCT00885690
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertindole	Sertindole	Sertindole 16-24 mg
Olanzapine	Olanzapine	Olanzapine 10-20 mg

Primary Outcome Measures

Name	Time	Method
CANTAB cognitive test battery	Baseline - 6 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Aalborg Psychiatric Hospital; 🇩🇰 Aalborg, Denmark

Universitets Allmänna Sjukhuset, Malmø UMAS; 🇸🇪 Malmø, Sweden