Nctid:
NCT00001481
Payload:
{"FullStudy"=>{"Rank"=>474191, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019052", "ConditionMeshTerm"=>"Depression, Postpartum"}, {"ConditionMeshId"=>"D000003863", "ConditionMeshTerm"=>"Depression"}, {"ConditionMeshId"=>"D000019964", "ConditionMeshTerm"=>"Mood Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001526", "ConditionAncestorTerm"=>"Behavioral Symptoms"}, {"ConditionAncestorId"=>"D000003866", "ConditionAncestorTerm"=>"Depressive Disorder"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000011644", "ConditionAncestorTerm"=>"Puerperal Disorders"}, {"ConditionAncestorId"=>"D000011248", "ConditionAncestorTerm"=>"Pregnancy Complications"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6748", "ConditionBrowseLeafName"=>"Depression", "ConditionBrowseLeafAsFound"=>"Depression", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6751", "ConditionBrowseLeafName"=>"Depressive Disorder", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20766", "ConditionBrowseLeafName"=>"Depression, Postpartum", "ConditionBrowseLeafAsFound"=>"Postpartum Depression", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21525", "ConditionBrowseLeafName"=>"Mood Disorders", "ConditionBrowseLeafAsFound"=>"Mood Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14189", "ConditionBrowseLeafName"=>"Puerperal Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4508", "ConditionBrowseLeafName"=>"Behavioral Symptoms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26783", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8089", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004958", "InterventionMeshTerm"=>"Estradiol"}, {"InterventionMeshId"=>"D000011374", "InterventionMeshTerm"=>"Progesterone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000004967", "InterventionAncestorTerm"=>"Estrogens"}, {"InterventionAncestorId"=>"D000006728", "InterventionAncestorTerm"=>"Hormones"}, {"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000011372", "InterventionAncestorTerm"=>"Progestins"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M13935", "InterventionBrowseLeafName"=>"Progesterone", "InterventionBrowseLeafAsFound"=>"Mechanical", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7798", "InterventionBrowseLeafName"=>"Estradiol", "InterventionBrowseLeafAsFound"=>"Cell lymphoma", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M266250", "InterventionBrowseLeafName"=>"Estradiol 17 beta-cypionate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M266251", "InterventionBrowseLeafName"=>"Estradiol 3-benzoate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M234895", "InterventionBrowseLeafName"=>"Polyestradiol phosphate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7806", "InterventionBrowseLeafName"=>"Estrogens", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9478", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M13934", "InterventionBrowseLeafName"=>"Progestins", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Reproductive Control Agents", "InterventionBrowseBranchAbbrev"=>"Repr"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Non-Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Investigator"]}}, "DesignPrimaryPurpose"=>"Basic Science", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"100"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"April 26, 1996", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 28, 2023", "CompletionDateStruct"=>{"CompletionDate"=>"June 13, 2025", "CompletionDateType"=>"Anticipated"}, "LastUpdateSubmitDate"=>"December 7, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 8, 2023", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"May 13, 2025", "PrimaryCompletionDateType"=>"Anticipated"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH.", "PrimaryOutcomeTimeFrame"=>"ongoing", "PrimaryOutcomeDescription"=>"Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"Yes", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Postpartum Disorders", "Mood", "Hormones", "GnRH Agonist", "Postpartum Depression"]}, "ConditionList"=>{"Condition"=>["Postpartum Depression"]}}, "ReferencesModule"=>{"SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1995-M-0097.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone.\n\nThe appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a \"scaled-down\" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).", "DetailedDescription"=>"The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a scaled-down hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major affective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estradiol and progesterone for an additional month. Outcome measures will include mood, behavioral, and hormonal parameters."}, "EligibilityModule"=>{"Gender"=>"Female", "MaximumAge"=>"50 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nA. Group 1: Women with a history of postpartum depression:\n\nA history of DSM-IV major depression or hypomanic/manic episode that occurred within three months of childbirth (as determined by a SCID interview);\nhas been well for a minimum of one year;\na regular menstrual cycle for at least three months;\nage 18-50;\nnot pregnant, not lactating and in good medical health;\nmedication free (including birth control pills);\nno history of puerperal suicide attempts or psychotic episodes requiring hospitalization.\n\nGroup 2: Women with a history of Major Depressive Disorder\n\nA history of DSM-IV major depression episode(s) occurring outside of pregnancy and not within three months postpartum;\nhas been well for a minimum of one year;\na regular menstrual cycle for at least three months;\nage 18-50;\nnot pregnant, not lactating and in good medical health;\nmedication free (including birth control pills);\nno history of suicide attempts or psychotic episodes requiring hospitalization.\n\nGroup 3; Normal Controls\n\nControls will meet all criteria specified except they must not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders.\n\nEXCLUSION CRITERIA:\n\nPatients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any history of the following:\n\nendometriosis;\n\nundiagnosed enlargement of the ovaries;\n\nliver disease;\n\nbreast cancer;\n\na history of blood clots in the legs or lungs;\n\nundiagnosed vaginal bleeding;\n\nporphyria;\n\ndiabetes mellitus;\n\nmalignant melanoma;\n\ngallbladder or pancreatic disease;\n\nheart or kidney disease;\n\ncerebrovascular disease (stroke);\n\ncigarette smoking;\n\na history of suicide attempts or psychotic episodes requiring hospitalization;\n\nrecurrent migraine headaches;\n\npregnancy (patients will be warned not to become pregnant during the study and will be advised to employ barrier contraceptive methods;\n\npregnancy-related medical conditions such as hyperemesis gravidarum, pretoxemia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis;\n\nAny woman with a first degree relative (immediate family) with premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol;\n\nAny woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause will be excluded from participation. Specifically, we will exclude any woman with an elevated plasma FSH level (greater than or equal to 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length;\n\nSubjects who are unable to provide informed consent;\n\nNIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy."}, "IdentificationModule"=>{"NCTId"=>"NCT00001481", "BriefTitle"=>"The Role of Hormones in Postpartum Mood Disorders", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"An Endocrine Model for Postpartum Mood Disorders", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950097"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-M-0097"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Group 1, Hormone and Placebo Group", "ArmGroupDescription"=>"8 weeks of hormonal addback plus 4 weeks of placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Estradiol", "Other: Placebo", "Drug: Progesterone"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Group 2, Continued Replacement Group", "ArmGroupDescription"=>"12 weeks of hormone addback", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Estradiol", "Drug: Progesterone"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Estradiol", "InterventionType"=>"Drug", "InterventionDescription"=>"To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Group 1, Hormone and Placebo Group", "Group 2, Continued Replacement Group"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Other", "InterventionDescription"=>"To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Group 1, Hormone and Placebo Group"]}}, {"InterventionName"=>"Progesterone", "InterventionType"=>"Drug", "InterventionDescription"=>"To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Group 1, Hormone and Placebo Group", "Group 2, Continued Replacement Group"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center"}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"Peter J Schmidt, M.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"peterschmidt@mail.nih.gov", "CentralContactPhone"=>"(301) 496-6120"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Peter J Schmidt, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Mental Health (NIMH)"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"Yes", "IPDSharingTimeFrame"=>"Starting 24 months after final publication", "IPDSharingDescription"=>".Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.", "IPDSharingInfoTypeList"=>{"IPDSharingInfoType"=>["Study Protocol", "Statistical Analysis Plan (SAP)", "Informed Consent Form (ICF)", "Clinical Study Report (CSR)"]}, "IPDSharingAccessCriteria"=>"Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator."}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Mental Health (NIMH)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}