Clinical trial NCT02021201: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-12-27
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Psychophysiological parameters sensory gating
timeFrame: baseline, after ten weeks and after 20 weeks
Secondary outcomes:
measure: Psychophysiological parameters of selective attention
timeFrame: Baseline, 10 weeks and 20 weeks after treatment
measure: Neurocognitive parameters of amongst others executive functioning, attention, and reaction time
timeFrame: 10 weeks and 20 weeks after treatment
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Study officials:
affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
name: Birte Y Glenthoj, PhD
role: STUDY_DIRECTOR
affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
name: Bob Oranje, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
name: Birgitte Fagerlund, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
name: Rita S Godske, MD
role: PRINCIPAL_INVESTIGATOR
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