Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT04745494
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies of Mothers With Postnatal Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maternal mood', 'timeFrame': 'Baseline, 35-45 minutes after intervention administration', 'description': 'Change in maternal mood will be assessed using the PANAS questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in maternal mindmindedness', 'timeFrame': 'Baseline, 35-45 minutes after intervention administration', 'description': "Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual"}, {'measure': 'Change in mother-infant interactional style', 'timeFrame': 'Baseline, 35-45 minutes after intervention administration', 'description': "Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual"}, {'measure': 'Change in maternal OT', 'timeFrame': 'Baseline, 35-45 minutes after intervention administration', 'description': 'Change in maternal salivary and breast milk OT will be assayed'}, {'measure': 'Change in infant OT', 'timeFrame': 'Baseline, 35-45 minutes after intervention administration', 'description': 'Change in infant salivary OT will be assayed'}, {'measure': 'Maternal gaze during interaction with her infant', 'timeFrame': '35-45 minutes after intervention administration', 'description': 'Maternal gaze will be assessed using a Tobii X2-30 eye tracker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxytocin'], 'conditions': ['Postnatal Depression']}, 'referencesModule': {'references': [{'pmid': '34843839', 'type': 'DERIVED', 'citation': 'Lindley Baron-Cohen K, Feldman R, Fearon P, Fonagy P. Intranasal oxytocin administration improves mood in new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression: A randomised controlled trial. J Affect Disord. 2022 Mar 1;300:358-365. doi: 10.1016/j.jad.2021.11.062. Epub 2021 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).', 'detailedDescription': 'A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.\n\nParticipants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.\n\nAll participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All mothers will be aged ≥18 years old.\n* Mothers in the clinical group will score above the clinical cut-off point on the EPDS.\n* Mothers in the control group will score below the clinical cut-off point on the EPDS.\n* Mothers must be able to read and write English at a level sufficient to complete study related assessments.\n\nExclusion Criteria:\n\n* If the mother is younger than 18 or post-menopausal\n* If the pregnancy was a result of fertility treatment\n* If the mother is pregnant\n* If the mother has history of psychotic illness\n* If the mother is at risk of self-harm\n* If the mother is involved in other active drug trials'}, 'identificationModule': {'nctId': 'NCT04745494', 'briefTitle': 'Studies of Mothers With Postnatal Depression', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Studies of Mothers With Postnatal Depression', 'orgStudyIdInfo': {'id': '16/0679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OT administration', 'description': 'All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.', 'interventionNames': ['Other: OT administration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo administration', 'description': 'All participants will receive a single dose of a placebo delivered via a nasal spray.', 'interventionNames': ['Other: Placebo administration']}], 'interventions': [{'name': 'OT administration', 'type': 'OTHER', 'description': 'OT nasal administration', 'armGroupLabels': ['OT administration']}, {'name': 'Placebo administration', 'type': 'OTHER', 'description': 'Placebo nasal administration', 'armGroupLabels': ['Placebo administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1E 7HB', 'city': 'London', 'state': 'UK', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}