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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Sertindole; Drug: Olanzapine	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	11 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multicentre Double-blinded Randomized Head-to-head Study
Study Start Date :	April 2009
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	November 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. CANTAB cognitive test battery [ Time Frame: Baseline - 6 and 12 weeks ]

Secondary Outcome Measures :

1. Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [ Time Frame: Baseline - 6 and 12 weeks ]
2. 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 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	April 22, 2009
Last Update Posted:	September 4, 2013
Last Verified:	September 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