The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers

September 14, 2012 updated by: University of Zurich
This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, CH-8032
        • University of Psychiatry Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age: 18-40
  • Gender: male

Exclusion Criteria:

  • Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
  • Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
  • Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
  • ECG: QTc-interval >450 msec.
  • Systolic blood pressure <100 mmHg
  • Bradycardia (Hf < 50/Min) und Arrhythmias
  • Hypokalemia or Hypomagnesemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Healthy volunteers with high sensory gating levels.
Drug: Sertindole
oral 3 x 4mg
Drug: Placebo
3 x 4mg Placebo
Experimental: 1
Healthy volunteers with low sensory gating levels.
Drug: Sertindole
oral 3 x 4mg
Drug: Placebo
3 x 4mg Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time Frame: after placebo and and after medical treatment
after placebo and and after medical treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive performances
Time Frame: after placebo and and after medical treatment
after placebo and and after medical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

H. Lundbeck A/S
Psychiatric University Hospital, Zurich

Investigators

  • Principal Investigator: Franz X. Vollenweider, Prof. Dr. med., University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 14, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97_PPI-P50
  • E-07/2007
  • 2007DR1251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Sertindole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe