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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Sertindole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014