Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 7:43 AM
Study NCT ID:
NCT00229450
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estrogen and Perimenopausal Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2005-09-28', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood', 'timeFrame': '6 weeks', 'description': '17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Memory', 'timeFrame': '6 weeks', 'description': 'The Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.'}]}, 'conditionsModule': {'keywords': ['depression', 'menopause', 'perimenopause', 'mood', 'memory', 'perimenopausal', 'antidepressant', 'estrogen'], 'conditions': ['Depressive Disorder, Major', 'Menopause']}, 'referencesModule': {'references': [{'pmid': '15960574', 'type': 'BACKGROUND', 'citation': 'Morgan ML, Cook IA, Rapkin AJ, Leuchter AF. Estrogen augmentation of antidepressants in perimenopausal depression: a pilot study. J Clin Psychiatry. 2005 Jun;66(6):774-80. doi: 10.4088/jcp.v66n0617.'}, {'pmid': '12112157', 'type': 'BACKGROUND', 'citation': 'Cook IA, Morgan ML, Dunkin JJ, David S, Witte E, Lufkin R, Abrams M, Rosenberg S, Leuchter AF. Estrogen replacement therapy is associated with less progression of subclinical structural brain disease in normal elderly women: a pilot study. Int J Geriatr Psychiatry. 2002 Jul;17(7):610-8. doi: 10.1002/gps.644.'}]}, 'descriptionModule': {'briefSummary': 'During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants\n* HAM-D between 10 and 17\n\nExclusion Criteria:\n\n* History of Psychosis, breast cancer, smoking, dementia, clotting disorders\n* Current substance abuse'}, 'identificationModule': {'nctId': 'NCT00229450', 'briefTitle': 'Estrogen and Perimenopausal Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression', 'orgStudyIdInfo': {'id': 'NARSAD06806-001'}, 'secondaryIdInfos': [{'id': '06806-001'}, {'id': '04-05-088'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '0.625 mg/day of conjugated estrogen', 'interventionNames': ['Drug: Estrogen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily placebo for conjugated estrogen', 'interventionNames': ['Drug: Estrogen']}], 'interventions': [{'name': 'Estrogen', 'type': 'DRUG', 'description': '0.625 mg/day of conjugated Estrogen', 'armGroupLabels': ['Placebo', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Neuropsychiatric Institute & Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Melinda L. Morgan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Alliance for Research on Schizophrenia and Depression', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}