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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Sertindole
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertindole<br>Sertindole 16-24 mg | Drug: Sertindole<br>* Sertindole 16-24 mg once daily<br>* Other names: Serdolect;|
| Active Comparator: Olanzapine<br>Olanzapine 10-20 mg | Drug: Olanzapine<br>* Olanzapine 10-20 mg<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CANTAB cognitive test battery |  | Baseline - 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Antipsychotic, Cognition