Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA) (SEROLA)
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ClinicalTrials.gov Identifier: NCT00885690 |
Recruitment Status
:
Terminated
(Due to recruitment problems)
First Posted
: April 22, 2009
Last Update Posted
: September 4, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Sertindole Drug: Olanzapine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicentre Double-blinded Randomized Head-to-head Study |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sertindole
Sertindole 16-24 mg
|
Drug: Sertindole
Sertindole 16-24 mg once daily
Other Name: Serdolect
|
Active Comparator: Olanzapine
Olanzapine 10-20 mg
|
Drug: Olanzapine
Olanzapine 10-20 mg
Other Name: Zyprexa
|
- CANTAB cognitive test battery [ Time Frame: Baseline - 6 and 12 weeks ]
- Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [ Time Frame: 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) [ Time Frame: Baseline, 6 and 12 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885690
Denmark | |
Aalborg Psychiatric Hospital | |
Aalborg, Denmark, 9000 | |
Sweden | |
Universitets Allmänna Sjukhuset, Malmø UMAS | |
Malmø, Sweden |
Principal Investigator: | René Nielsen, M.D. | Aalborg Psychiatric Hospital, Aarhus University Hospital |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00885690 History of Changes |
Other Study ID Numbers: |
3.1 - 01-25-09 Eudra CT nr: 2008-008366-13 |
First Posted: | April 22, 2009 Key Record Dates |
Last Update Posted: | September 4, 2013 |
Last Verified: | September 2013 |
Keywords provided by University of Aarhus:
Schizophrenia Antipsychotic Cognition |
Additional relevant MeSH terms:
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Sertindole Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |