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The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

risperidone

Sertindole

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Psychophysiological parameters sensory gating

Secondary Outcome Measures

Psychophysiological parameters of selective attention

Neurocognitive parameters of amongst others executive functioning, attention, and reaction time

Full Information

NCT ID

NCT02021201

First Posted

September 19, 2011

Last Updated

March 24, 2020

Sponsor

Birte Glenthoj

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02021201

Brief Title

The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

No suitable patients could be recruited in the available time period

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Birte Glenthoj

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

risperidone

Other Intervention Name(s)

Risperdal

Intervention Description

Patients with schizophrenia will be treated for 10 weeks treatment with risperidone

Intervention Type

Drug

Intervention Name(s)

Sertindole

Other Intervention Name(s)

Serdolect

Intervention Description

Patients with schizophrenia will be treated for 10 weeks treatment with serindole

Primary Outcome Measure Information:

Title

Psychophysiological parameters sensory gating

Time Frame

baseline, after ten weeks and after 20 weeks

Secondary Outcome Measure Information:

Title

Psychophysiological parameters of selective attention

Time Frame

Baseline, 10 weeks and 20 weeks after treatment

Title

Neurocognitive parameters of amongst others executive functioning, attention, and reaction time

Time Frame

10 weeks and 20 weeks after treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Birte Y Glenthoj, PhD

Organizational Affiliation