The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02021201
• Other study ID #: H-A-2008-062
• Status: Terminated
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: July 2013

Study information

• Verified date: March 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• risperidone
Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
• Sertindole
Patients with schizophrenia will be treated for 10 weeks treatment with serindole

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Birte Glenthoj	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychophysiological parameters sensory gating		baseline, after ten weeks and after 20 weeks
Secondary	Psychophysiological parameters of selective attention		Baseline, 10 weeks and 20 weeks after treatment
Secondary	Neurocognitive parameters of amongst others executive functioning, attention, and reaction time		10 weeks and 20 weeks after treatment

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