Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 11:24 AM
Study NCT ID:
NCT04902235
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-07', 'releaseDate': '2024-08-26'}], 'estimatedResultsFirstSubmitDate': '2024-08-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D020790', 'term': 'Diabetes Insipidus, Neurogenic'}, {'id': 'C580003', 'term': 'Combined Pituitary Hormone Deficiency'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'participants will be blinded to the intervention assignment'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single-blind, randomized, placebo-controlled proof-of-concept studies with a crossover assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in oxytocin concentration', 'timeFrame': 'Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection', 'description': 'Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl)'}], 'secondaryOutcomes': [{'measure': 'Maximal change in oxytocin concentration (pg/mL)', 'timeFrame': 'Within the two hours after the injection', 'description': 'Maximal change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl'}, {'measure': 'Overall oxytocin secretion', 'timeFrame': 'Within the two hours after the injection', 'description': 'Oxytocin area under the curve after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl'}, {'measure': 'Change in cortisol concentration (nmol/L)', 'timeFrame': 'Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection', 'description': 'Change in cortisol concentration (nmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl'}, {'measure': 'Change in adrenocorticotropic hormone (ACTH) values', 'timeFrame': 'Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection', 'description': 'Change in ACTH values (pmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl'}, {'measure': 'Mood assessment', 'timeFrame': 'Baseline', 'description': 'Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Baseline', 'description': 'Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL)'}, {'measure': 'Impulsivity assessment', 'timeFrame': 'Baseline', 'description': 'Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)'}, {'measure': 'Alexithymia assessment', 'timeFrame': 'Baseline', 'description': 'Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxytocin', 'panhypopituitarism', 'central diabetes insipidus', 'hypothalamus-pituitary diseases', 'cortisol', 'ACTH', 'corticorelin hormone'], 'conditions': ['Hypopituitarism', 'Central Diabetes Insipidus', 'Panhypopituitarism', 'Psychological Disorder', 'Social Isolation', 'Hypothalamic Diseases', 'Pituitary Diseases', 'Oxytocin Deficiency']}, 'referencesModule': {'references': [{'pmid': '39824923', 'type': 'DERIVED', 'citation': 'Asla Q, Garrido M, Urgell E, Terzan S, Santos A, Fernandez M, Varghese N, Atila C, Calabrese A, Biagetti B, Plessow F, Gich I, Christ-Crain M, Eckert A, Webb SM, Lawson EA, Aulinas A. Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial. Sci Rep. 2025 Jan 18;15(1):2360. doi: 10.1038/s41598-025-86566-y.'}]}, 'descriptionModule': {'briefSummary': 'Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology, prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, corticorelin hormone (CRH) has shown to increase OT release.\n\nThis study is designed to evaluate oxytocin values after administration of CRH in adults (healthy volunteers and patients with hypopituitarism).\n\nThe investigators hypothesize that OT response will be blunted following CRH in patients with hypopituitarism compared to healthy controls.', 'detailedDescription': 'This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.\n\nThe aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (CRH vs placebo), placebo-control design.\n\nClinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hypopituitarism (HYPO) (\\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months\n* At least one clinical sign of hypothalamic damage\n* Female participants will be done in the early to midfollicular phase\n\nExclusion Criteria:\n\n* uncorrected hormone deficiency\n* creatinine \\>1.5mg/dL\n* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5x upper limit of normal\n* hematocrit less than 30%\n* suicidality or active psychosis\n* participation in a trial with investigational drugs within 30 days\n* using a high glucocorticoid dose\n* vigorous physical exercise\n* alcohol intake within 24 hours before the study participation\n* evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety\n* pregnancy or breastfeeding for last 8 weeks\n* known allergies towards CRH\n* patients refusing or unable to give written informed consent\n* Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.'}, 'identificationModule': {'nctId': 'NCT04902235', 'briefTitle': 'Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept Physiopathological Study (CRH Study)', 'orgStudyIdInfo': {'id': 'IIBSP-OXI-2020-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRH administration', 'description': 'Experimental: CRH administration', 'interventionNames': ['Drug: Experimental: CRH administration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo administration', 'description': 'Control: Placebo administration', 'interventionNames': ['Drug: Control: Placebo administration']}], 'interventions': [{'name': 'Experimental: CRH administration', 'type': 'DRUG', 'description': "CRH at 1.0 µg/kg/body weight will be injected intravenously as a bolus over 30 seconds and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after CRH:placebo administration to assess OT secretory patterns", 'armGroupLabels': ['CRH administration']}, {'name': 'Control: Placebo administration', 'type': 'DRUG', 'description': 'Sodium Chloride 0.9% will be administered intravenously as a bolus over 30 seconds at equivalent volume than CRH administration (1.0 µg/kg/body weight)', 'armGroupLabels': ['Placebo administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Anna Aulinas, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-26', 'type': 'RELEASE'}, {'date': '2024-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}}}}