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

Schizophrenia Clinical Trial

— SEROLA  

Official title:

A Multicentre Double-blinded Randomized Head-to-head Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00885690
• Other study ID #: 3.1 - 01-25-09
• Secondary ID: Eudra CT nr: 200
• Status: Terminated
• Phase: N/A
• First received: April 20, 2009
• Last updated: September 3, 2013
• Start date: April 2009
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Sertindole
Sertindole 16-24 mg once daily
• Olanzapine
Olanzapine 10-20 mg

Locations

Country	Name	City	State
Denmark	Aalborg Psychiatric Hospital	Aalborg
Sweden	Universitets Allmänna Sjukhuset, Malmø UMAS	Malmø

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Psychiatric Hospital, Malmö University

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CANTAB cognitive test battery		Baseline - 6 and 12 weeks	No
Secondary	Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure		Baseline - 6 and 12 weeks	No
Secondary	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)		Baseline, 6 and 12 weeks	No