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

This study is ongoing, but not recruiting participants.

First Received: January 23, 2008 Last Updated: September 8, 2008 History of Changes

Sponsors and Collaborators:	University of Zurich Psychiatric University Hospital, Zurich Lundbeck (Switzerland)
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00612079

Purpose

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.

Condition	Intervention
Healthy	Drug: Sertindole Drug: Placebo

Drug Information available for: Sertindole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) [ Time Frame: after placebo and and after medical treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognitive performances [ Time Frame: after placebo and and after medical treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Healthy volunteers with high sensory gating levels.	Drug: Sertindole oral 3 x 4mg Drug: Placebo 3 x 4mg Placebo
1: Experimental Healthy volunteers with low sensory gating levels.	Drug: Sertindole oral 3 x 4mg Drug: Placebo 3 x 4mg Placebo

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612079

Locations

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

Sponsors and Collaborators

University of Zurich

Psychiatric University Hospital, Zurich

Lundbeck (Switzerland)

Investigators

Study Chair:	Franz X. Vollenweider, Prof. Dr. med.	University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Principal Investigator:	Dominique H. Holstein, lic. phil.	University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Principal Investigator:	Nicole Brugger, cand. phil.	University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

More Information

No publications provided

Responsible Party:	Head of the Department Neuropsychopharmacology and Brain Imaging ( Prof. Dr. med. F. X. Vollenweider )
Study ID Numbers:	97_PPI-P50, E-07/2007, 2007DR1251
Study First Received:	January 23, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00612079 History of Changes
Health Authority:	Switzerland: Swissmedic and; Switzerland: Ethikkommission

Keywords provided by University of Zurich:

Sertindole
sensory gating
PPI
P50 suppression

CANTAB
Effect of Sertindole on sensory gating (P50 suppression)
on sensorimotor gating (PPI)
and cognition (CANTAB)

Study placed in the following topic categories:

Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants

Sertindole
Healthy
Antipsychotic Agents

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Sertindole
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009