Schizophrenia
Conditions
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.
Interventions
DRUGrisperidone
Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
DRUGSertindole
Patients with schizophrenia will be treated for 10 weeks treatment with serindole
Sponsors
Icahn School of Medicine at Mount Sinai
Birte Glenthoj
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychophysiological parameters sensory gating | baseline, after ten weeks and after 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed