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

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ClinicalTrials.gov Identifier: NCT00885690
Recruitment Status : Terminated (Due to recruitment problems)
First Posted : April 22, 2009
Last Update Posted : September 4, 2013
Sponsor:
Collaborators:
Aalborg Psychiatric Hospital
Malmö University
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. CANTAB cognitive test battery [ Time Frame: Baseline - 6 and 12 weeks ]

Secondary Outcome Measures :
  1. Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure [ Time Frame: Baseline - 6 and 12 weeks ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by University of Aarhus:
Schizophrenia
Antipsychotic
Cognition

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Sertindole
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents