The Effects of Increased Central Serotonergic Activity on Information Processing

This study has been completed.
Sponsor:
Collaborators:
Lundbeck Foundation
Glostrup University Hospital, Copenhagen
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00206934
First received: September 12, 2005
Last updated: September 16, 2011
Last verified: July 2008
  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 Volunteers
Drug: Escitalopram
Drug: escitaolpram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • The PPI (Prepulse Inhibition of the Startle Response) task [ Time Frame: Once, 3.5 hrs after intake of capsule ] [ Designated as safety issue: No ]
  • The P50 Suppression task [ Time Frame: Once, 3.5 hrs after intake of capsule ] [ Designated as safety issue: No ]
  • The P300 ERP task [ Time Frame: Once, 3.5 hrs after intake of capsule ] [ Designated as safety issue: No ]
  • The mismatch negativity (MMN) task [ Time Frame: Once, 3.5 hrs after intake of capsule ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Escitalopram
Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers
Other Name: Cipralex
Placebo Comparator: 2 Drug: escitaolpram
Either 15 mg of escitalopram or placebo will be administered to healthy volunteers
Other Name: Cipralex

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
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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
University of Copenhagen
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

Additional Information:
No publications provided

Responsible Party: Birte Glenthoj, Professor of Psychopharmacology and Neuropsychiatry, Danish Center for Neuropsychiatric Schizophrenia Research
ClinicalTrials.gov Identifier: NCT00206934     History of Changes
Other Study ID Numbers: 363037-1
Study First Received: September 12, 2005
Last Updated: September 16, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by University of Copenhagen:
PPI
P50 suppression
P300
mismatch negativity
escitalopram

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

ClinicalTrials.gov processed this record on August 19, 2014