Comparison of the effects of Sertindole and Olanzapine on Cognition - SEROLA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Both genders
2.Between 18 and 65 years of age
3.The ICD-10 schizophrenia diagnosis F20.0-F20.3 and F20.9 (paranoid, hebephrenic, catatonic, undifferentiated and unspecified)
4.That all fertile women must use a safe form of birth control (birth control pills, spiral, gestagen depot injection, sub dermal implantation, hormonal vaginal ring and transdermal depot patch)
5.A negative pregnancy test for women
6.No known allergy to any of the substances in the study medication
7.Baseline QTc < 450 milliseconds for men and < 470 milliseconds for women
8.S-potassium and s-magnesium within normal reference range.
9.Sub optimally treated on current antipsychotic medication
10.Stable dosage of antidepressants and mood stabilizers one month before the inclusion
11.Signed informed consent and power of attorney

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Withdrawal of consent
2.QTc prolongation >500 milliseconds
3.Patients with known clinical important cardiovascular disease e.g., heart insufficiency, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
4.Significant addictions interfering with outcome and compliance
5.Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine.
6.Calgary Depression Scale score = 7
7.Treatment that interferes with the metabolism of sertindole or olanzapine, e.g. potent inhibitors of CYP1A2, CYP3A4 and CYP2D6, e.g. ketoconazole, fluvoxamine and fluoxetine as described in the SPC of Serdolect
8.Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing
9.Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period
10.Treatment with an anticholinergic after the first three weeks of the study
11.Somatic illness, as judged by investigator, interfering with cognition, e.g. delirium
12.Treatment with electroconvulsive therapy (ECT) the last three months before inclusion, or treatment with ECT in the study period
13.Treatment with clozapine or depot antipsychotics before inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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