Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 5:54 PM
Study NCT ID:
NCT00666068
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2008-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007018', 'term': 'Hypopituitarism'}], 'ancestors': [{'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003346', 'term': 'Corticotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep-EEG variables, conventionally and quantitatively analyzed', 'timeFrame': 'within the first month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with hypopituitarism'], 'conditions': ['Hypopituitarism']}, 'descriptionModule': {'briefSummary': 'In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.\n\nIt is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.\n\nTo date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with hypopituitarism\n\nInclusion Criteria:\n\n* Age 18-75 years\n* Complete insufficiency of the anterior pituitary\n* Stable hormone substitution for at least 3 months\n\nExclusion Criteria:\n\n* Hormone excess in the past\n* Sleep disorder, e.g. sleep apnea syndrome\n\nHealthy controls\n\nInclusion Criteria:\n\n* Age 18-75 years\n\nExclusion Criteria:\n\n* Any medication during 6 week prior to study entry\n* Shift work'}, 'identificationModule': {'nctId': 'NCT00666068', 'briefTitle': 'Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism', 'organization': {'class': 'OTHER', 'fullName': 'Max-Planck-Institute of Psychiatry'}, 'officialTitle': 'Effects of CRH on the Sleep in Patients With Hypopituitarism', 'orgStudyIdInfo': {'id': 'L2/2003A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients with hypopituitarism\n\nCross over design: see interventions 1-2', 'interventionNames': ['Other: corticotropin releasing hormone (CRH)', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Parallel design:\n\nHealthy controls to be compared with placebo condition in patients with hypopituitarism', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'corticotropin releasing hormone (CRH)', 'type': 'OTHER', 'description': '50 µg injected at 2200, 2300, 0000, and 0100', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'injected at 2200, 2300, 0000, and 0100', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'injected at 2200, 2300, 0000, and 0100', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80804', 'city': 'Munich', 'country': 'Germany', 'facility': 'Max Planck Institute of Psychiatry', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max-Planck-Institute of Psychiatry', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Axel Steiger', 'oldOrganization': 'Max-Planck-Institute of Psychiatry'}}}}