The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: risperidone; Drug: Sertindole

• Registration Number: NCT02021201
• Lead Sponsor: Birte Glenthoj

Brief 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2011-09-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	risperidone	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
1	Sertindole	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
2	risperidone	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
2	Sertindole	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

Primary Outcome Measures

Name	Time	Method
Psychophysiological parameters sensory gating	baseline, after ten weeks and after 20 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup; 🇩🇰 Glostrup, Denmark