Clinical trial NCT00885690: Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)
Official title: A Multicentre Double-blinded Randomized Head-to-head Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic
Cognition
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg Psychiatric Hospital
name: Malmö University
First posted: 2009-04-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: CANTAB cognitive test battery
timeFrame: Baseline - 6 and 12 weeks
Secondary outcomes:
measure: Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
timeFrame: Baseline - 6 and 12 weeks
measure: 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)
timeFrame: Baseline, 6 and 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Psychiatric Hospital
city: Malmø
country: Sweden
facility: Universitets Allmänna Sjukhuset, Malmø UMAS
Study officials:
affiliation: Aalborg Psychiatric Hospital, Aarhus University Hospital
name: René Nielsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: