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

NCT00629252 | Terminated

• 3 other identifiers: 98_PPI-P50E-11/20072007DR1253
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; PPI; P50; CANTAB; sensory gating; Schizophrenic patients according to DSM-IV

Outcome Measures

Primary Outcomes (1)

• sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)

  Before and six weeks after antipsychotic treatment

Secondary Outcomes (2)

• Cognitive performances

  Before and six weeks after antipsychotic treatment

• Psychopathology (PANSS rating)

  Before and six weeks after antipsychotic treatment

Study Arms (3)

1

EXPERIMENTAL

Schizophrenic patients treated with sertindole

Drug: Sertindole

2

ACTIVE COMPARATOR

Schizophrenic patients treated with risperidone

Drug: Risperidone

3

NO INTERVENTION

Healthy controls without any treatment.

Interventions

Sertindole DRUG

oral 12-20 mg/day

1

Risperidone DRUG

oral 2-6mg / day

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Schizophrenia according to DSM IV
• Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging: collaborator
• H. Lundbeck A/S: collaborator

Study Sites (1)

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Zurich, Canton of Zurich, CH-8032, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Franz X. Vollenweider, Prof. Dr. med.

  University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

CH (1)