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

September 14, 2012 updated by: University of Zurich
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, CH-8032
        • University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Schizophrenic patients treated with sertindole
Drug: Sertindole
oral 12-20 mg/day
Active Comparator: 2
Schizophrenic patients treated with risperidone
Drug: Risperidone
oral 2-6mg / day
No Intervention: 3
Healthy controls without any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time Frame: Before and six weeks after antipsychotic treatment
Before and six weeks after antipsychotic treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive performances
Time Frame: Before and six weeks after antipsychotic treatment
Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)
Time Frame: Before and six weeks after antipsychotic treatment
Before and six weeks after antipsychotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

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

Investigators

  • Principal Investigator: Franz X. Vollenweider, Prof. Dr. med., University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 14, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98_PPI-P50
  • E-11/2007
  • 2007DR1253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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