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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sertindole
Olanzapine
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic, Cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aalborg Psychiatric Hospital
  • Universitets Allmänna Sjukhuset, Malmø UMAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sertindole

Olanzapine

Arm Description

Sertindole 16-24 mg

Olanzapine 10-20 mg

Outcomes

Primary Outcome Measures

CANTAB cognitive test battery

Secondary Outcome Measures

Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
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)

Full Information

First Posted
April 20, 2009
Last Updated
September 3, 2013
Sponsor
University of Aarhus
Collaborators
Aalborg Psychiatric Hospital, Malmö University
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1. Study Identification

Unique Protocol Identification Number
NCT00885690
Brief Title
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)
Acronym
SEROLA
Official Title
A Multicentre Double-blinded Randomized Head-to-head Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to recruitment problems
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg Psychiatric Hospital, Malmö University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertindole
Arm Type
Active Comparator
Arm Description
Sertindole 16-24 mg
Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Description
Olanzapine 10-20 mg
Intervention Type
Drug
Intervention Name(s)
Sertindole
Other Intervention Name(s)
Serdolect
Intervention Description
Sertindole 16-24 mg once daily
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
Olanzapine 10-20 mg
Primary Outcome Measure Information:
Title
CANTAB cognitive test battery
Time Frame
Baseline - 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure
Time Frame
Baseline - 6 and 12 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Nielsen, M.D.
Organizational Affiliation
Aalborg Psychiatric Hospital, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Psychiatric Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Universitets Allmänna Sjukhuset, Malmø UMAS
City
Malmø
Country
Sweden

12. IPD Sharing Statement

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