MedDataX Logo

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

NCT ID: NCT00629252

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Schizophrenic patients treated with sertindole

Group Type EXPERIMENTAL

Sertindole

Intervention Type DRUG

oral 12-20 mg/day

2

Schizophrenic patients treated with risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

oral 2-6mg / day

3

Healthy controls without any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sertindole

oral 12-20 mg/day

Intervention Type DRUG

Risperidone

oral 2-6mg / day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

OTHER

Sponsor Role collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franz X. Vollenweider, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-11/2007

Identifier Type: -

Identifier Source: secondary_id

2007DR1253

Identifier Type: -

Identifier Source: secondary_id

98_PPI-P50

Identifier Type: -

Identifier Source: org_study_id