The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia
Information source: University of Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: risperidone (Drug); Sertindole (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Birte Glenthoj Official(s) and/or principal investigator(s): Birte Y Glenthoj, PhD, Study Director, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Bob Oranje, PhD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Birgitte Fagerlund, PhD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Rita S Godske, MD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Summary
This comparison is made between the effects of sertindole and risperidone on vulnerability
indicators in schizophrenia. More specifically: the effects of these two antipsychotic
compounds on basic processing of incoming information is studied. The investigators expect
that the newer antipsychotic sertindole to be more effective in restoring information
processing in schizophrenia patients than risperidone.
Clinical Details
Official title: The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia, a Comparative Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Psychophysiological parameters sensory gating
Secondary outcome: Psychophysiological parameters of selective attentionNeurocognitive parameters of amongst others executive functioning, attention, and reaction time
Detailed description:
The study is has a so-called double blind, randomized - yet balanced - cross-over design, in
which 24 male patients with schizophrenia are included. After inclusion in the study,
patients will be assessed in a test-battery, in which psychophysiological parameters of
their basic information capabilities are quantified. Following this, the patients will be
treated with either risperidone or sertindole for a period of 10 weeks, after which they
will cross-over to the other treatment (the order of treatments is randomized (and
balanced)). The battery of tests is repeated after the first and second treatment period. In
addition, a second test-battery will be performed at these follow-up intervals, to assess
neuropsychological parameters of information processing. To evaluate the extend of the
treatment effects, the patients will be matched (age, gender, parental socioeconomic status)
to 24 healthy controls.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
Healthy controls:
- matched by age (+/- 2 years), gender and parental socioeconomic status to patients
with schizophrenia.
- age between 18-55 years
- male
- physically and mentally healthy and no daily intake of medicine
- no current substance abuse
Patients:
- patients who fulfill both ICD-10 and DSM IV diagnostic criteria for schizophrenia.
- age between 18-55 years
- male
- patients who need a change in their medication
- diagnosed with schizophrenia within the last 10 years
- not formerly treated with risperidone (Risperdal) or sertindole (Serdolect) where
treatment was stopped because of side effects or lack of effect
- physically healthy
- no current substance abuse
Exclusion Criteria:
Controls:
- a history of mental illness in the first degree relatives
- hearing disabilities
- head injury accompanied by unconsciousness for more than 5 min.
- physical illness with a need of daily intake of medicine
- positive screening for drugs of abuse at baseline.
Patients:
- head injury accompanied by unconsciousness for more than 5 min.
- serious medical conditions (more specific: brain diseases and diseases which cause a
daily intake of medicine, heart, liver or kidney diseases, diabetes and prolongation
of the QTc-interval (or a family history of such) and patients with phenylketonuri)
- abuse of alcohol or medication/ narcotics during the last 6 months or positive
screening for drugs of abuse at baseline.
- former treatment with risperidone (Risperdal) or sertindole (Serdolect) where
treatment was stopped because of side effects or lack of effect
- hearing disability
- allergy towards the content in the medicine used in the study
- bradycardia (pulse under 50 beats per minute) and QTc>450 ms
Locations and Contacts
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup, Glostrup DK-2600, Denmark
Additional Information
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Starting date: July 2008
Last updated: December 19, 2013
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