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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00885690

Acronym

SEROLA

Enrollment

Registered

2009-04-22

Start date

2009-04-30

Completion date

2012-11-30

Last updated

2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Antipsychotic, Cognition

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.

Interventions

DRUGSertindole

Sertindole 16-24 mg once daily

DRUGOlanzapine

Olanzapine 10-20 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
CANTAB cognitive test battery	Baseline - 6 and 12 weeks

Secondary

Measure	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

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026