The Effects of Increased Central Serotonergic Activity on Information Processing

NCT ID: NCT00206934

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-03-31

Brief 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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

Escitalopram

Intervention Type: DRUG

Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers

2

Group Type: PLACEBO_COMPARATOR

escitaolpram

Intervention Type: DRUG

Either 15 mg of escitalopram or placebo will be administered to healthy volunteers

Interventions

Escitalopram

Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers

Intervention Type: DRUG

escitaolpram

Either 15 mg of escitalopram or placebo will be administered to healthy volunteers

Intervention Type: DRUG

Other Intervention Names

Cipralex; Cipralex

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Danish Center for Neuropsychiatric Schizophrenia Research

Principal Investigators

Birte Glenthoj, MD, DMSc.

Role: STUDY_DIRECTOR

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

Locations

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Glostrup Municipality, , Denmark

Countries

Denmark

Related Links

http://www.cnsr.dk

Center for Neuropsychiatric Schizophrenia Research (CNSR)

Other Identifiers

363037-1

Identifier Type: -

Identifier Source: org_study_id