The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia, a Comparative Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: risperidone
* Drug: Sertindole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound | Drug: risperidone<br>* Patients with schizophrenia will be treated for 10 weeks treatment with risperidone<br>* Other names: Risperdal;Drug: Sertindole<br>* Patients with schizophrenia will be treated for 10 weeks treatment with serindole<br>* Other names: Serdolect;|
| Experimental: 2<br>Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound | Drug: risperidone<br>* Patients with schizophrenia will be treated for 10 weeks treatment with risperidone<br>* Other names: Risperdal;Drug: Sertindole<br>* Patients with schizophrenia will be treated for 10 weeks treatment with serindole<br>* Other names: Serdolect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysiological parameters sensory gating |  | baseline, after ten weeks and after 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysiological parameters of selective attention |  | Baseline, 10 weeks and 20 weeks after treatment | 
| Neurocognitive parameters of amongst others executive functioning, attention, and reaction time |  | 10 weeks and 20 weeks after treatment |