The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Zurich
• Collaborators: H. Lundbeck A/S; University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
• Treatments: Risperidone; Sertindole

Criteria

Inclusion Criteria:

• Schizophrenia according to DSM IV

• Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)

Exclusion Criteria:

• DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.

• DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.

• ECG: QTc-interval >450 msec.

• Systolic blood pressure <100 mmHg

• Bradycardia (Hf < 50/Min) und Arrhythmias

• Hypokalemia or Hypomagnesemia