Study of Premenstrual Syndrome and Premenstrual Dysphoria

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Nctid: NCT00001177

Payload: {"FullStudy"=>{"Rank"=>474448, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000011293", "ConditionMeshTerm"=>"Premenstrual Syndrome"}, {"ConditionMeshId"=>"D000019964", "ConditionMeshTerm"=>"Mood Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000008599", "ConditionAncestorTerm"=>"Menstruation Disturbances"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13857", "ConditionBrowseLeafName"=>"Premenstrual Syndrome", "ConditionBrowseLeafAsFound"=>"Premenstrual Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21525", "ConditionBrowseLeafName"=>"Mood Disorders", "ConditionBrowseLeafAsFound"=>"Mood Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11272", "ConditionBrowseLeafName"=>"Menstruation Disturbances", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"1600"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"March 9, 1984", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 31, 2023", "LastUpdateSubmitDate"=>"October 18, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 19, 2023", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including...", "PrimaryOutcomeTimeFrame"=>"Ongoing", "PrimaryOutcomeDescription"=>"Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels)."}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression).", "SecondaryOutcomeTimeFrame"=>"ongoing", "SecondaryOutcomeDescription"=>"Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression)."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Cognition", "Neuroendocrine", "PMS Premenstrual Syndrome", "MRMD Menstrually Related Mood Disorder", "Menstrual"]}, "ConditionList"=>{"Condition"=>["Mood Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1404717", "ReferenceType"=>"background", "ReferenceCitation"=>"Rubinow DR. The premenstrual syndrome. New views. JAMA. 1992 Oct 14;268(14):1908-12. No abstract available."}, {"ReferencePMID"=>"9435325", "ReferenceType"=>"background", "ReferenceCitation"=>"Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401."}, {"ReferencePMID"=>"7906420", "ReferenceType"=>"background", "ReferenceCitation"=>"Bancroft J. The premenstrual syndrome--a reappraisal of the concept and the evidence. Psychol Med. 1993;Suppl 24:1-47. doi: 10.1017/s0264180100001272."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1981-M-0126.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).\n\nWomen who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.", "DetailedDescription"=>"The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses. This will be accomplished by means of clinical interviews, self-rating scales, and periodic evaluation of mood and endocrine function. We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrine/neurophysiologic studies (companion protocols) in an attempt to identify endocrinologic or physiologic measures that might: 1) be associated with the discrete changes in mood and behavior; 2) distinguish this group from a group of age-matched controls; 3) allow for further subgroup definition on the basis of predicted response to pharmacological intervention. Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders."}, "EligibilityModule"=>{"Gender"=>"Female", "MaximumAge"=>"50 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "SamplingMethod"=>"Non-Probability Sample", "StudyPopulation"=>"This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.", "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nThe subjects of this study will be women who meet the following criteria:\n\nhistory within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress;\na 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles;\nage 18 to 50;\nnot pregnant and in good medical health;\nregular menses.\n\nFor subjects with recurrent brief depression:\n\ndysphoric mood or loss of interest or pleasure;\nduration less than two weeks;\nfour of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness;\nimpairment in usual occupational activities;\nat least one-two episodes per month over one year.\n\nAge-matched women without mood and behavioral disorders will be recruited.\n\nEXCLUSION CRITERIA for all study participants:\n\nSubjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);\nCurrent antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them;\nCurrent alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).\nPregnant or lactating women\nSubjects who are unable to provide informed consent\nNIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy."}, "IdentificationModule"=>{"NCTId"=>"NCT00001177", "BriefTitle"=>"Study of Premenstrual Syndrome and Premenstrual Dysphoria", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders", "OrgStudyIdInfo"=>{"OrgStudyId"=>"810126"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"81-M-0126"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"healthy volunteers", "ArmGroupDescription"=>"healthy females"}, {"ArmGroupLabel"=>"patients", "ArmGroupDescription"=>"females with menstrually-related mood or behavioral difficulties"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center", "LocationContactList"=>{"LocationContact"=>[{"LocationContactName"=>"NIH Clinical Center Office of Patient Recruitment (OPR)", "LocationContactRole"=>"Contact", "LocationContactEMail"=>"ccopr@nih.gov", "LocationContactPhone"=>"800-411-1222", "LocationContactPhoneExt"=>"TTY dial 711"}]}}]}, "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"}}}}}}