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

Sponsor

University of Aarhus (Other)

Overall Status

Terminated

CT.gov ID

NCT00885690

Collaborator

Aalborg Psychiatric Hospital (Other), Malmö University (Other)

Enrollment

Locations

Arms

Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Sertindole Drug: Olanzapine	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2009

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Sertindole

Sertindole 16-24 mg

Drug: Sertindole

Sertindole 16-24 mg once daily

Other Names:

Serdolect

Active Comparator: Olanzapine

Olanzapine 10-20 mg

Drug: Olanzapine

Olanzapine 10-20 mg

Other Names:

Zyprexa

Outcome Measures

Primary Outcome Measures

CANTAB cognitive test battery [Baseline - 6 and 12 weeks]

Secondary Outcome Measures

Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [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) [Baseline, 6 and 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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