Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 3:19 PM
Study NCT ID:
NCT03577457
Status:
UNKNOWN
Last Update Posted:
2018-07-12
First Post:
2018-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Interaction Between Oxytocin and Serotonin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in brain neural activity during the social reward processing as assessed via fMRI', 'timeFrame': 'approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo', 'description': 'Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in response to social reward task in different treatment groups.'}, {'measure': 'Changes in the resting state as assessed via fMRI', 'timeFrame': 'Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo', 'description': 'Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups'}], 'secondaryOutcomes': [{'measure': 'Associations with Personalities of subjects', 'timeFrame': 'before 30mins ATD or placebo administration', 'description': "Personalities of subjects will be measured by a series of scales related to decision making and social reward, such as the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), which measures participants' sensitivity to reward and punishment. SPSRQ is a self-reported instrument that includes 48 yes/no questions divided into two subscales: Sensitivity to Reward (SR, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to reward) and Sensitivity to Punishment (SP, 24 items, ranging from 0 (insensitive) to 24 (sensitive) to punishment). Associations between individual differences in personalities of subjects and differences in behaviors will be measured."}, {'measure': 'Behavioral performance in decision making task', 'timeFrame': 'approximately 4h after administration of ATD, or placebo, before nasal spray', 'description': 'Behavioral performance in reversal learning task will be measured and compared between treatment groups.'}, {'measure': 'Behavioral performance in social reward related task', 'timeFrame': 'approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo', 'description': 'Behavioral performance will be measured and compared between treatment groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxytocin', 'serotonin', 'social reward', 'decision making'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design', 'detailedDescription': 'Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.'}, '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* Right-handedness\n\nExclusion Criteria:\n\n* History of head injury;\n* Medical or psychiatric illness.\n* High blood pressure, general cardio-vascular alterations\n* History of drug or alcohol abuse or addiction.\n* Allergy against medications or general strong allergies\n* Sleep disorders.\n* Visual or motor impairments'}, 'identificationModule': {'nctId': 'NCT03577457', 'briefTitle': 'The Interaction Between Oxytocin and Serotonin', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'The Interaction Between Oxytocin and Serotonin on the Social-reward Brain Networks and Decision Making', 'orgStudyIdInfo': {'id': 'SANP-2017-3-ATD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'male oxytocin and ATD group', 'description': 'male subjects receiving oxytocin and ATD treatment', 'interventionNames': ['Drug: oxytocin nasal spray', 'Drug: ATD treatment']}, {'type': 'EXPERIMENTAL', 'label': 'male oxytocin and placebo group', 'description': 'male subjects receiving oxytocin and ATD-placebo treatment', 'interventionNames': ['Drug: oxytocin nasal spray', 'Drug: oral placebo treatment (placebo-control for ATD)']}, {'type': 'EXPERIMENTAL', 'label': 'male placebo and ATD group', 'description': 'male subjects receiving oxytocin placebo and ATD treatment', 'interventionNames': ['Drug: ATD treatment', 'Drug: intranasal placebo treatment (placebo-control for oxytocin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'male placebo group', 'description': 'male subjects receiving oxytocin placebo and ATD placebo treatment', 'interventionNames': ['Drug: intranasal placebo treatment (placebo-control for oxytocin)', 'Drug: oral placebo treatment (placebo-control for ATD)']}], 'interventions': [{'name': 'oxytocin nasal spray', 'type': 'DRUG', 'description': 'intranasal administration of oxytocin (24 IU)', 'armGroupLabels': ['male oxytocin and ATD group', 'male oxytocin and placebo group']}, {'name': 'ATD treatment', 'type': 'DRUG', 'description': 'oral administration of ATD (75.2g) (Acute Tryptophan Depletion)', 'armGroupLabels': ['male oxytocin and ATD group', 'male placebo and ATD group']}, {'name': 'intranasal placebo treatment (placebo-control for oxytocin)', 'type': 'DRUG', 'description': 'intranasal administration of placebo nasal spray', 'armGroupLabels': ['male placebo and ATD group', 'male placebo group']}, {'name': 'oral placebo treatment (placebo-control for ATD)', 'type': 'DRUG', 'description': 'oral administration of a tryptophan-balanced mixture (78.2g)', 'armGroupLabels': ['male oxytocin and placebo group', 'male placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100875', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Normal University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yina Ma, Dr.', 'role': 'CONTACT', 'email': 'yma@bnu.edu.cn', 'phone': '+86-15221877059'}]}, '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'}}}}