Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA) (SEROLA)
This study has been terminated.
(Due to recruitment problems)
Sponsor:
University of Aarhus
Collaborators:
Aalborg Psychiatric Hospital
Malmö University
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00885690
First received: April 20, 2009
Last updated: September 3, 2013
Last verified: September 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: Sertindole Drug: Olanzapine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicentre Double-blinded Randomized Head-to-head Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- CANTAB cognitive test battery [ Time Frame: Baseline - 6 and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [ Time Frame: Baseline - 6 and 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | April 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885690
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885690
Locations
| Denmark | |
| Aalborg Psychiatric Hospital | |
| Aalborg, Denmark, 9000 | |
| Sweden | |
| Universitets Allmänna Sjukhuset, Malmø UMAS | |
| Malmø, Sweden | |
Sponsors and Collaborators
University of Aarhus
Aalborg Psychiatric Hospital
Malmö University
Investigators
| Principal Investigator: | René Nielsen, M.D. | Aalborg Psychiatric Hospital, Aarhus University Hospital |
More Information
| 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 |
| Study First Received: | April 20, 2009 |
| Last Updated: | September 3, 2013 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics |
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 |
ClinicalTrials.gov processed this record on September 26, 2016