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

This study has been terminated.

(Due to recruitment problems)

Sponsor:

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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

Drug Information available for: Olanzapine Olanzapine pamoate

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 ]

Secondary Outcome Measures:

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 ]


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)
Sexes Eligible for Study:	All
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

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

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 July 21, 2017

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