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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629252
• Other study ID #: 98_PPI-P50
• Secondary ID: E-11/20072007DR1
• Status: Terminated
• Phase: N/A
• First received: January 21, 2008
• Last updated: September 14, 2012
• Start date: February 2008
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Sertindole
oral 12-20 mg/day
• Risperidone
oral 2-6mg / day

Locations

Country	Name	City	State
Switzerland	University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging	Zurich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	H. Lundbeck A/S, University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)		Before and six weeks after antipsychotic treatment	No
Secondary	Cognitive performances		Before and six weeks after antipsychotic treatment	No
Secondary	Psychopathology (PANSS rating)		Before and six weeks after antipsychotic treatment	No