The Effects of Increased Central Serotonergic Activity on Information Processing
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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 |
- 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 |
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| Denmark | |
| Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | |
| Glostrup, Denmark, DK-2600 | |
| 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013