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

This study is ongoing, but not recruiting participants.

First Received: April 20, 2009 Last Updated: April 21, 2009 History of Changes

Sponsors and Collaborators:	University of Aarhus Aalborg Psychiatric Hospital University of Malmo
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00885690

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicentre Double-Blinded Randomized Head-to-Head Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Sertindole Olanzapine

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 ] [ 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:	100
Study Start Date:	April 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sertindole: Active Comparator Sertindole 16-24 mg	Drug: Sertindole Sertindole 16-24 mg once daily
Olanzapine: Active Comparator Olanzapine 10-20 mg	Drug: Olanzapine Olanzapine 10-20 mg

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

University of Malmo

More Information

No publications provided

Responsible Party:	Aalborg Psychiatric Hospital ( Jimmi Nielsen )
Study ID Numbers:	3.1 - 01-25-09, Eudra CT nr: 2008-008366-13
Study First Received:	April 20, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00885690 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Schizophrenia
Antipsychotic
Cognition

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors

Serotonin
Schizophrenia
Mental Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Sertindole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Sertindole
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 24, 2009