NCT00885690TerminatedNot Applicable
A Multicentre Double-blinded Randomized Head-to-head Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Aarhus
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- CANTAB cognitive test battery
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Sertindole
Active Comparator
Sertindole 16-24 mg
Intervention: Sertindole (Drug)
Olanzapine
Active Comparator
Olanzapine 10-20 mg
Intervention: Olanzapine (Drug)
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)
Investigators
Study Sites (2)
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