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

September 3, 2013 updated by: University of Aarhus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark, 9000
        • Aalborg Psychiatric Hospital
      • Malmø, Sweden
        • Universitets Allmänna Sjukhuset, Malmø UMAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sertindole
Sertindole 16-24 mg
Sertindole 16-24 mg once daily
Other Names:
  • Serdolect
Active Comparator: Olanzapine
Olanzapine 10-20 mg
Olanzapine 10-20 mg
Other Names:
  • Zyprexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CANTAB cognitive test battery
Time Frame: Baseline - 6 and 12 weeks
Baseline - 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
Time Frame: Baseline - 6 and 12 weeks
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
Baseline, 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: René Nielsen, M.D., Aalborg Psychiatric Hospital, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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