Back to resultsThe Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sertindole
Risperidone
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV
Eligibility 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
Sites / Locations
- University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
1
2
3
Arm Description
Schizophrenic patients treated with sertindole
Schizophrenic patients treated with risperidone
Healthy controls without any treatment.
Outcomes
Primary Outcome Measures
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Secondary Outcome Measures
Cognitive performances
Psychopathology (PANSS rating)
Full Information
NCT ID
NCT00629252
First Posted
January 21, 2008
Last Updated
September 14, 2012
Sponsor
University of Zurich
Collaborators
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging, H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00629252
Brief Title
The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Not enough subjects have been recruited in the expected period.
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging, H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Schizophrenic patients treated with sertindole
Arm Title
2
Arm Type
Active Comparator
Arm Description
Schizophrenic patients treated with risperidone
Arm Title
3
Arm Type
No Intervention
Arm Description
Healthy controls without any treatment.
Intervention Type
Drug
Intervention Name(s)
Sertindole
Intervention Description
oral 12-20 mg/day
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
oral 2-6mg / day
Primary Outcome Measure Information:
Title
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time Frame
Before and six weeks after antipsychotic treatment
Secondary Outcome Measure Information:
Title
Cognitive performances
Time Frame
Before and six weeks after antipsychotic treatment
Title
Psychopathology (PANSS rating)
Time Frame
Before and six weeks after antipsychotic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz X. Vollenweider, Prof. Dr. med.
Organizational Affiliation
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
City
Zurich
State/Province
ZH
ZIP/Postal Code
CH-8032
Country
Switzerland
12. IPD Sharing Statement
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The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
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