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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612079
First Posted: February 11, 2008
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Psychiatric University Hospital, Zurich
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

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 ]

Secondary Outcome Measures:
  • Cognitive performances [ Time Frame: after placebo and and after medical treatment ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612079


Locations
Switzerland
University of Psychiatry Hospital
Zurich, ZH, Switzerland, CH-8032
Sponsors and Collaborators
University of Zurich
Psychiatric University Hospital, Zurich
H. Lundbeck A/S
Investigators
Principal Investigator: Franz X. Vollenweider, Prof. Dr. med. University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
  More Information

Publications:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00612079     History of Changes
Other Study ID Numbers: 97_PPI-P50
E-07/2007
2007DR1251
First Submitted: January 23, 2008
First Posted: February 11, 2008
Last Update Posted: September 17, 2012
Last Verified: September 2012

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)

Additional relevant MeSH terms:
Sertindole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs