The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
This study has been terminated.
(Not enough subjects have been recruited in the expected period.)
Sponsor:
University of Zurich
Collaborators:
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00629252
First received: January 21, 2008
Last updated: September 14, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: Sertindole Drug: Risperidone |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [ Time Frame: Before and six weeks after antipsychotic treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cognitive performances [ Time Frame: Before and six weeks after antipsychotic treatment ] [ Designated as safety issue: No ]
- Psychopathology (PANSS rating) [ Time Frame: Before and six weeks after antipsychotic treatment ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | February 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629252
Locations
| Switzerland | |
| University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging | |
| Zurich, ZH, Switzerland, CH-8032 | |
Sponsors and Collaborators
University of Zurich
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
H. Lundbeck A/S
Investigators
| Principal Investigator: | Franz X. Vollenweider, Prof. Dr. med. | University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00629252 History of Changes |
| Other Study ID Numbers: | 98_PPI-P50, E-11/2007, 2007DR1253 |
| Study First Received: | January 21, 2008 |
| Last Updated: | September 14, 2012 |
| Health Authority: | Switzerland: Swissmedic Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
Schizophrenia PPI P50 |
CANTAB sensory gating Schizophrenic patients according to DSM-IV |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Sertindole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013