The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

NCT ID: NCT02021201

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

risperidone

Intervention Type: DRUG

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

Sertindole

Intervention Type: DRUG

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

2

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

Group Type: EXPERIMENTAL

risperidone

Intervention Type: DRUG

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

Sertindole

Intervention Type: DRUG

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

Interventions

risperidone

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

Intervention Type: DRUG

Sertindole

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

Intervention Type: DRUG

Other Intervention Names

Risperdal; Serdolect

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Birte Glenthoj

OTHER

Sponsor Role: lead

Responsible Party

Birte Glenthoj

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Birte Y Glenthoj, PhD

Role: STUDY_DIRECTOR

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

Bob Oranje, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Birgitte Fagerlund, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Rita S Godske, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Glostrup Municipality, , Denmark

Countries

Denmark

Related Links

https://www.psykiatri-regionh.dk/cinsr/Pages/default.aspx

Homepage of our organization

Other Identifiers

H-A-2008-062

Identifier Type: -

Identifier Source: org_study_id