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No suitable patients could be recruited in the available time period
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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 |
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| 2 | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risperidone | Drug | Patients with schizophrenia will be treated for 10 weeks treatment with risperidone |
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| Measure | Description | Time Frame |
|---|---|---|
| Psychophysiological parameters sensory gating | baseline, after ten weeks and after 20 weeks |
| 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 |
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Inclusion Criteria:
Healthy controls:
Patients:
Exclusion Criteria:
Controls:
Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Birte Y Glenthoj, PhD | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Study Director |
| Bob Oranje, PhD | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Principal Investigator |
| Birgitte Fagerlund, PhD | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Principal Investigator |
| Rita S Godske, MD | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Glostrup Municipality | DK-2600 | Denmark |
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| Label | URL |
|---|---|
| Homepage of our organization | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| C066304 | sertindole |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sertindole | Drug | Patients with schizophrenia will be treated for 10 weeks treatment with serindole |
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