NCT02021201

The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Birte Glenthoj · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	risperidone	Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
DRUG	Sertindole	Patients with schizophrenia will be treated for 10 weeks treatment with serindole

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-12-27
• Last updated: 2020-03-26

Locations

1 site across 1 country: Denmark