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

Sponsor

University of Zurich (Other)

Overall Status

Terminated

CT.gov ID

NCT00629252

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Schizophrenia	Drug: Sertindole Drug: Risperidone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [Before and six weeks after antipsychotic treatment]

Secondary Outcome Measures

Cognitive performances [Before and six weeks after antipsychotic treatment]
Psychopathology (PANSS rating) [Before and six weeks after antipsychotic treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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