Status:
TERMINATED
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aalborg Psychiatric Hospital
Malmö University
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00885690
Start Date
April 1 2009
End Date
November 1 2012
Last Update
September 4 2013
Active Locations (2)
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1
Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000
2
Universitets Allmänna Sjukhuset, Malmø UMAS
Malmo, Sweden