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

University of Zurich (UZH)

Status: Terminated

Conditions: Schizophrenia

Treatments: Drug: Sertindole; Drug: Risperidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00629252

98_PPI-P50

2007DR1253

E-11/2007

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 3 patient groups

1

Experimental group

Description:

Schizophrenic patients treated with sertindole

Treatment:

Drug: Sertindole

2

Active Comparator group

Description:

Schizophrenic patients treated with risperidone

Treatment:

Drug: Risperidone

3

No Intervention group

Description:

Healthy controls without any treatment.