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

This study has been terminated.
(Due to recruitment problems)
Sponsor:
Collaborators:
Aalborg Psychiatric Hospital
Malmö University
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00885690
First received: April 20, 2009
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention
Schizophrenia
Drug: Sertindole
Drug: Olanzapine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Double-blinded Randomized Head-to-head Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • CANTAB cognitive test battery [ Time Frame: Baseline - 6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [ Time Frame: Baseline - 6 and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885690

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

No publications provided

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
Study First Received: April 20, 2009
Last Updated: September 3, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Schizophrenia
Antipsychotic
Cognition

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Sertindole
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 30, 2014