The Effect of Sertindole on Sensory Gating and Cognition... | NCT00629252

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

NCT00629252

Sponsor

University of Zurich

Status

Terminated

Last Update Posted

Sep 17, 2012Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Sertindole
Risperidone

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough subjects have been recruited in the expected period.

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Feb 26, 2008

First Posted Date

Mar 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2012

Last Update Posted Date

Sep 17, 2012Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sertindole	Drug	oral 12-20 mg/day	1
Risperidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)		Before and six weeks after antipsychotic treatment

Secondary Outcomes

Measure	Description	Time Frame
Cognitive performances		Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)		Before and six weeks after antipsychotic treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franz X. Vollenweider, Prof. Dr. med.	University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging		Zurich	Canton of Zurich	CH-8032	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C066304	sertindole
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
E-11/2007
2007DR1253