The Effects of Increased Central Serotonergic Activity on Information Processing

Healthy Volunteers Clinical Trial

Official title:

The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206934
• Other study ID #: 363037-1
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 16, 2011
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: July 2008
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Escitalopram
Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers
• escitaolpram
Either 15 mg of escitalopram or placebo will be administered to healthy volunteers

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Glostrup University Hospital, Copenhagen, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The PPI (Prepulse Inhibition of the Startle Response) task		Once, 3.5 hrs after intake of capsule	No
Primary	The P50 Suppression task		Once, 3.5 hrs after intake of capsule	No
Primary	The P300 ERP task		Once, 3.5 hrs after intake of capsule	No
Primary	The mismatch negativity (MMN) task		Once, 3.5 hrs after intake of capsule	No

External Links

•   Center for Neuropsychiatric Schizophrenia Research (CNSR)