- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00885690
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA) (SEROLA)
September 3, 2013 updated by: University of Aarhus
A Multicentre Double-blinded Randomized Head-to-head Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sertindole
Sertindole 16-24 mg
|
Sertindole 16-24 mg once daily
Other Names:
|
Active Comparator: Olanzapine
Olanzapine 10-20 mg
|
Olanzapine 10-20 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CANTAB cognitive test battery
Time Frame: Baseline - 6 and 12 weeks
|
Baseline - 6 and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
Time Frame: Baseline - 6 and 12 weeks
|
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
|
Baseline, 6 and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: René Nielsen, M.D., Aalborg Psychiatric Hospital, Aarhus University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
April 20, 2009
First Submitted That Met QC Criteria
April 21, 2009
First Posted (Estimate)
April 22, 2009
Study Record Updates
Last Update Posted (Estimate)
September 4, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
- Sertindole
Other Study ID Numbers
- 3.1 - 01-25-09
- Eudra CT nr: 2008-008366-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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