Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-07-23 @ 9:54 PM
Study NCT ID:
NCT03426202
Status:
UNKNOWN
Last Update Posted:
2019-06-17
First Post:
2018-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Modafinil on Affective and Cognitive Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neural processing during the interference processing', 'timeFrame': '4h after treatment', 'description': 'fMRI BOLD indices of neural processing in interference related brain regions will be compared between the treatment and placebo group.'}, {'measure': 'Neural processing during feedback based learning', 'timeFrame': '4h after treatment', 'description': 'fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group.'}], 'secondaryOutcomes': [{'measure': 'Behavioral interference performance - Response Time', 'timeFrame': '4h after treatment', 'description': 'Behavioral performance of interference performance for congruent and incongruent stimuli (picture vs word) will be compared between the treatment and placebo group.'}, {'measure': 'Behavioral interference performance - Accuracy', 'timeFrame': '4h after treatment', 'description': 'Behavioral performance of interference in terms of accuracy for congruent and incongruent trials (picture vs word) will be compared between the treatment and placebo group.'}, {'measure': 'Behavioral learning performance - Reaction time', 'timeFrame': '4h after treatment', 'description': 'Learning performance in terms of reaction times will be compared between the treatment and placebo group.'}, {'measure': 'Behavioral learning performance - Accuracy', 'timeFrame': '4h after treatment', 'description': 'Learning performance in terms of accuracy (learning curve, trials to reach plateau) will be compared between the treatment and placebo group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['modafinil', 'emotion', 'cognitive processing'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect feedback-based learning and interference processing in healthy male subjects.', 'detailedDescription': 'Based on previous animal and human research suggesting a catecholamine-mediated, potentially pro-cognitive, mechanism of action of modafinil, the present study seeks to explore effects of modafinil on feedback-based learning and interference processing in healthy subjects. To this end, the present randomized double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment plans to determine the behavioral and neural effects of a single dose of p.o.modafinil (200mg) versus placebo on validated feedback-based learning and emotional/non-emotional cognitive conflict paradigms. To control for potential effects of pre-medication personality traits as well as effects of modafinil on subjective task performance, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of meta-cognitive confidence estimation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects without past or current psychiatric or neurological disorders\n* Non-smokers\n* Right-handedness\n\nExclusion Criteria:\n\n* Medical or psychiatric illness\n* Allergy against medications or general strong allergies\n* Sleep disorders\n* High blood pressure, general cardio-vascular alterations\n* History of head injury\n* Visual or motor impairments'}, 'identificationModule': {'nctId': 'NCT03426202', 'briefTitle': 'The Effect of Modafinil on Affective and Cognitive Processing', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modafinil group', 'description': 'a single dose of p.o. modafinil (200mg)', 'interventionNames': ['Drug: Modafinil Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'placebo group', 'description': 'a single dose of p.o. placebo (200mg)', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Modafinil Oral Tablet', 'type': 'DRUG', 'description': 'modafinil 200mg', 'armGroupLabels': ['modafinil group']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'placebo 200mg', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Zhao', 'role': 'CONTACT', 'email': 'zarazhao.uestc@outlook.com', 'phone': '18780247797'}], 'facility': 'School of Life Science and Technology', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Electronic Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin Becker', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}