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

This study has been completed.
Sponsor:
Collaborators:
Psychiatric University Hospital, Zurich
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00612079
First received: January 23, 2008
Last updated: September 14, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 23, 2008
Last Updated: September 14, 2012
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)

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

ClinicalTrials.gov processed this record on July 28, 2014