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Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)

NCT ID: NCT00885690

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia Antipsychotic Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sertindole

Sertindole 16-24 mg

Group Type ACTIVE_COMPARATOR

Sertindole

Intervention Type DRUG

Sertindole 16-24 mg once daily

Olanzapine

Olanzapine 10-20 mg

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine 10-20 mg

Interventions

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Sertindole

Sertindole 16-24 mg once daily

Intervention Type DRUG

Olanzapine

Olanzapine 10-20 mg

Intervention Type DRUG

Other Intervention Names

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Serdolect Zyprexa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg Psychiatric Hospital

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René Nielsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aalborg Psychiatric Hospital, Aarhus University Hospital

Locations

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Aalborg Psychiatric Hospital

Aalborg, , Denmark

Site Status

Universitets Allmänna Sjukhuset, Malmø UMAS

Malmo, , Sweden

Site Status

Countries

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Denmark Sweden

Other Identifiers

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Eudra CT nr: 2008-008366-13

Identifier Type: -

Identifier Source: secondary_id

3.1 - 01-25-09

Identifier Type: -

Identifier Source: org_study_id