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:
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

January 21, 2008
September 14, 2012
February 2008
August 2012   (final data collection date for primary outcome measure)
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [ Time Frame: Before and six weeks after antipsychotic treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629252 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Schizophrenia
  • Drug: Sertindole
    oral 12-20 mg/day
  • Drug: Risperidone
    oral 2-6mg / day
  • Experimental: 1
    Schizophrenic patients treated with sertindole
    Intervention: Drug: Sertindole
  • Active Comparator: 2
    Schizophrenic patients treated with risperidone
    Intervention: Drug: Risperidone
  • No Intervention: 3
    Healthy controls without any treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00629252
98_PPI-P50, E-11/2007, 2007DR1253
No
University of Zurich
University of Zurich
  • University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
  • H. Lundbeck A/S
Principal Investigator: Franz X. Vollenweider, Prof. Dr. med. University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
University of Zurich
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP