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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2008

Last Updated Date

September 14, 2012

Start Date ^ICMJE

February 2008

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [ Time Frame: Before and six weeks after antipsychotic treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00629252 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Sertindole
oral 12-20 mg/day
Drug: Risperidone
oral 2-6mg / day

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00629252

Other Study ID Numbers ^ICMJE

98_PPI-P50, E-11/2007, 2007DR1253

Has Data Monitoring Committee

Responsible Party

University of Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
H. Lundbeck A/S

Investigators ^ICMJE

Principal Investigator:

Franz X. Vollenweider, Prof. Dr. med.

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Information Provided By

University of Zurich

Verification Date

September 2012

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

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