SchizophreniaSEROLANCT00885690
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)
A study testing Sertindole and Olanzapine in people with Schizophrenia, run by University of Aarhus at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sertindole and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- Sertindole, Olanzapine
- Keywords
- Schizophrenia, Antipsychotic, Cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertindoleDrug
Also called Serdolect
Sertindole 16-24 mg once daily
OlanzapineDrug
Also called Zyprexa
Olanzapine 10-20 mg
| Study group | Role | What they receive |
|---|---|---|
| Sertindole | Active comparator | Sertindole 16-24 mg Receives: Drug: Sertindole |
| Olanzapine | Active comparator | Olanzapine 10-20 mg Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTAB cognitive test battery
Measured: Baseline - 6 and 12 weeks
Secondary outcomes (2)
Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
Measured: 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)
Measured: Baseline, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital, Malmö University
- Responsible party
- Sponsor
- Investigators
- René Nielsen, M.D., Principal investigator, Aalborg Psychiatric Hospital, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885690
- Sponsor's protocol ID
- 3.1 - 01-25-09
- Other IDs
- Eudra CT nr: 2008-008366-13
- Acronym
- SEROLA
- Status last verified
- Sep 2013
- First submitted
- 20 Apr 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Double-blinded Randomized Head-to-head Study
- ClinicalTrials.gov ID
- NCT00885690
- Acronym / sponsor ID
- SEROLA / 3.1 - 01-25-09
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic, Cognition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment problems
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital, Malmö University
- Study start
- Apr 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertindole | Active comparator | Drug: SertindoleSertindole 16-24 mg |
| Olanzapine | Active comparator | Drug: OlanzapineOlanzapine 10-20 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertindoleAlso: SerdolectSertindole 16-24 mg once daily | Drug | Sertindole |
| OlanzapineAlso: ZyprexaOlanzapine 10-20 mg | Drug | Olanzapine |
Primary outcome
CANTAB cognitive test battery
Time frame: Baseline - 6 and 12 weeks
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Due to recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Nielsen, M.D. principal investigator
Aalborg Psychiatric Hospital, Aarhus University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertindole and Olanzapine in people with Schizophrenia, run by University of Aarhus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CANTAB cognitive test battery (time frame: Baseline - 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.