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

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Sertindole; Drug: Risperidone

• Registration Number: NCT00629252
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-21
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sertindole	Schizophrenic patients treated with sertindole
2	Risperidone	Schizophrenic patients treated with risperidone

Primary Outcome Measures

Name	Time	Method
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)	Before and six weeks after antipsychotic treatment

Secondary Outcome Measures

Name	Time	Method
Cognitive performances	Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)	Before and six weeks after antipsychotic treatment

Trial Locations

Locations (1)

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging; 🇨🇭 Zurich, ZH, Switzerland