The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: risperidone (Drug); Sertindole (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Birte Glenthoj

Official(s) and/or principal investigator(s):
Birte Y Glenthoj, PhD, Study Director, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Bob Oranje, PhD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Birgitte Fagerlund, PhD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Rita S Godske, MD, Principal Investigator, Affiliation: Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Psychophysiological parameters sensory gating

Secondary outcome:

Psychophysiological parameters of selective attention

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

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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup, Glostrup DK-2600, Denmark

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Starting date: July 2008
Last updated: December 19, 2013