Comparing the Effects of Sertindole and Olanzapine on Cognition (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: February 25, 2013
Last verified: February 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:
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 |
| 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
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
No publications provided
| 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: | February 25, 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 and Disorders with Psychotic Features Mental Disorders Sertindole Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 17, 2013