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

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ClinicalTrials.gov Identifier: NCT00629252
Recruitment Status : Terminated (Not enough subjects have been recruited in the expected period.)
First Posted : March 5, 2008
Last Update Posted : September 17, 2012
Sponsor:
Collaborators:
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment
Schizophrenia Drug: Sertindole Drug: Risperidone

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : February 2008
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [ Time Frame: Before and six weeks after antipsychotic treatment ]

Secondary Outcome Measures :
  1. Cognitive performances [ Time Frame: Before and six weeks after antipsychotic treatment ]
  2. Psychopathology (PANSS rating) [ Time Frame: Before and six weeks after antipsychotic treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00629252     History of Changes
Other Study ID Numbers: 98_PPI-P50
E-11/2007
2007DR1253
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by University of Zurich:
Schizophrenia
PPI
P50
CANTAB
sensory gating
Schizophrenic patients according to DSM-IV

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Sertindole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents