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The Effects of Increased Central Serotonergic Activity on Information Processing
This study has been completed.
Sponsors and Collaborators: Bispebjerg Hospital
University of Copenhagen
The Lundbeck Foundation
Glostrup University Hospital,Copenhagen
Information provided by: Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00206934
  Purpose

It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect information processing. Our hypothesis was that aspects of information processing would be disturbed whereas others would improve.


Condition Intervention
Healthy Volunters
Drug: Escitalopram

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title: The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • The PPI (Prepulse Inhibition of the Startle Response) task
  • The P50 Suppression task
  • The P300 ERP task
  • The mismatch negativity (MMN) task

Estimated Enrollment: 40
Study Start Date: March 2005
Estimated Study Completion Date: January 2006
Detailed Description:

Numerous studies point to an increased serotoninergic activity in schizophrenia. Additionally, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle refex (PPI). Currently, the reports in literature on the effects of serotonergic agonists on sensory gating in humans are inconclusive. In an initial study performed in our laboratory, however, we found reduced P50 suppression following administration of imipramine (a combined serotonin- and noradrenalin reuptake inhibitor) to healthy volunteers. This result provides evidence for the involvement of either serotonergic, noradrenergic, or a combination of both pathways in sensory gating. In numerous animal studies however, sensory gating is reduced by agonists of 5-HT, which suggests a serotonergic, rather than a noradrenergic, involvement in sensory gating. Therefore, in a follow-up study, the effects of a selective serotonin reuptake inhibitor (escitalopram) will be investigated on sensory gating parameters of healthy volunteers. To further extend the data of our initial study, the subjects will additionally be tested for two more psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will be a double blind, placebo controlled experiment, in which a single dose of escitalopram or placebo will be given to healthy, non-smoking male volunteers on two occasions, separated by at least a week, after which the subjects will be tested in the psychophysiological test battery.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects
  • Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist, ECG
  • Non smokers

Exclusion Criteria:

  • Current use of any medication
  • Any subject who has received any investigational medication within 30 days prior to the start of this study
  • History of neurologic illness
  • History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
  • History of alcohol and drug abuse. Positive urine screening for amphetamine, cocaine, cannabis, or esctacy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206934

Locations
Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
The Lundbeck Foundation
Glostrup University Hospital,Copenhagen
Investigators
Study Director: Birte Glenthoj, MD, DMSc. Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
  More Information

Center for Neuropsychiatric Schizophrenia Research (CNSR)  This link exits the ClinicalTrials.gov site

Study ID Numbers: 363037-1
Study First Received: September 12, 2005
Last Updated: September 11, 2006
ClinicalTrials.gov Identifier: NCT00206934  
Health Authority: Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:
PPI
P50 suppression
P300
mismatch negativity
escitalopram

Study placed in the following topic categories:
Healthy
Dexetimide
Citalopram
Serotonin

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009