Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT00206934
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Increased Central Serotonergic Activity on Information Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PPI (Prepulse Inhibition of the Startle Response) task', 'timeFrame': 'Once, 3.5 hrs after intake of capsule'}, {'measure': 'The P50 Suppression task', 'timeFrame': 'Once, 3.5 hrs after intake of capsule'}, {'measure': 'The P300 ERP task', 'timeFrame': 'Once, 3.5 hrs after intake of capsule'}, {'measure': 'The mismatch negativity (MMN) task', 'timeFrame': 'Once, 3.5 hrs after intake of capsule'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PPI', 'P50 suppression', 'P300', 'mismatch negativity', 'escitalopram'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cnsr.dk', 'label': 'Center for Neuropsychiatric Schizophrenia Research (CNSR)'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects\n* Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist, ECG\n* Non smokers\n\nExclusion Criteria:\n\n* Current use of any medication\n* Any subject who has received any investigational medication within 30 days prior to the start of this study\n* History of neurologic illness\n* History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria\n* History of alcohol and drug abuse. Positive urine screening for amphetamine, cocaine, cannabis, or esctacy.'}, 'identificationModule': {'nctId': 'NCT00206934', 'briefTitle': 'The Effects of Increased Central Serotonergic Activity on Information Processing', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing', 'orgStudyIdInfo': {'id': '363037-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: escitaolpram']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Cipralex'], 'description': 'Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers', 'armGroupLabels': ['1']}, {'name': 'escitaolpram', 'type': 'DRUG', 'otherNames': ['Cipralex'], 'description': 'Either 15 mg of escitalopram or placebo will be administered to healthy volunteers', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Birte Glenthoj, MD, DMSc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Birte Glenthoj, Professor of Psychopharmacology and Neuropsychiatry', 'oldOrganization': 'Danish Center for Neuropsychiatric Schizophrenia Research'}}}}