ID

45632

Description

Principal Investigator: Peter Schmidt, MD, National Institutes of Health, Bethesda, MD, USA MeSH: Premenstrual Dysphoric Disorder https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001344 In this study, lymphoblastoid cell line cultures (LCLs) from women with premenstrual dysphoric disorder (PMDD) and asymptomatic controls were compared via whole-transcriptome sequencing (RNA-seq) during untreated (ovarian steroid-free) conditions and after estradiol and progesterone treatment. In untreated LCLs, pathway analysis of the LCL transcriptome revealed, among others, over-expression of ESC/E(Z) complex genes (an ovarian steroid-regulated gene silencing complex) with significant overexpression of MTF2, PHF19, and SIRT1 (P0.05) in cells from women with PMDD compared with controls. Finally, mRNA expression of several ESC/E(Z) complex genes were increased by progesterone in controls only, and decreased by estradiol in PMDD LCLs.

Link

dbGaP study = phs001344

Keywords

Versions (1)
  1. 3/6/23 3/6/23 - Simon Heim
Copyright Holder

Peter Schmidt, MD, National Institutes of Health, Bethesda, MD, USA

Uploaded on

March 6, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs001344 GnRH Agonist-Induced Ovarian Suppression and Ovarian Steroids in PMDD and Controls

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Participant Selection:*
Description

*Participant Selection:*

Data type

boolean

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1707391
Women between the ages of 18 and 48 years who were medication-free, with regular menstrual cycles (range, 21 to 35 days), not medically ill and not pregnant were included in the clinical study.
Description

Women between the ages of 18 and 48 years who were medication-free, with regular menstrual cycles (range, 21 to 35 days), not medically ill and not pregnant were included in the clinical study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C2229012
UMLS CUI [1,6]
C3898900
UMLS CUI [1,7]
C0232973
UMLS CUI [1,8]
C0008972
Women with PMDD were self-referred in response to newspaper advertisements or were referred by their physician. The diagnosis of PMDD was confirmed prospectively prior to enter into this study by self-administered symptom ratings (a 100mm visual analog scale) completed daily over three consecutive menstrual cycles. In addition to meeting DSM IV criteria for PMDD, each woman had an increase of at least 30 percent (relative to the range of the scale she used) in average self-ratings of negative moods (irritability, depression, anxiety, and mood stability) in the seven days before menses compared with the ratings for the seven days after the end of menses, in at least two of the three baseline cycles. These are more stringent criteria than those of DSM-IV or V.
Description

Women with PMDD were self-referred in response to newspaper advertisements or were referred by their physician. The diagnosis of PMDD was confirmed prospectively prior to enter into this study by self-administered symptom ratings (a 100mm visual analog scale) completed daily over three consecutive menstrual cycles. In addition to meeting DSM IV criteria for PMDD, each woman had an increase of at least 30 percent (relative to the range of the scale she used) in average self-ratings of negative moods (irritability, depression, anxiety, and mood stability) in the seven days before menses compared with the ratings for the seven days after the end of menses, in at least two of the three baseline cycles. These are more stringent criteria than those of DSM-IV or V.

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0520676
UMLS CUI [1,3]
C3266254
UMLS CUI [1,4]
C0949214
UMLS CUI [1,5]
C2911692
UMLS CUI [1,6]
C3266257
UMLS CUI [1,7]
C0521091
UMLS CUI [1,8]
C0011900
UMLS CUI [1,9]
C5421123
UMLS CUI [1,10]
C0429688
UMLS CUI [1,11]
C0025329
UMLS CUI [1,12]
C0220952
UMLS CUI [1,13]
C0243161
UMLS CUI [1,14]
C0205217
UMLS CUI [1,15]
C1510992
UMLS CUI [1,16]
C0026516
UMLS CUI [1,17]
C0022107
UMLS CUI [1,18]
C0011570
UMLS CUI [1,19]
C0003467
UMLS CUI [1,20]
C0558224
UMLS CUI [1,21]
C0332152
UMLS CUI [1,22]
C0025344
UMLS CUI [1,23]
C0231290
Women without PMDD (control women) were recruited, and studied, in parallel. Absence of premenstrual mood symptoms was confirmed using the same daily rating scales during a two-month baseline period.
Description

Women without PMDD (control women) were recruited, and studied, in parallel. Absence of premenstrual mood symptoms was confirmed using the same daily rating scales during a two-month baseline period.

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0520676
UMLS CUI [1,4]
C0009932
UMLS CUI [1,5]
C2826345
UMLS CUI [1,6]
C0332197
UMLS CUI [1,7]
C0521091
UMLS CUI [1,8]
C0232959
UMLS CUI [1,9]
C2232697
UMLS CUI [1,10]
C0681889
UMLS CUI [1,11]
C1442488
Women with PMDD had no other current Axis I psychiatric diagnosis within the past two years per Structured Clinical Interview for DSM-IV (SCID), while control women had neither current nor past Axis I diagnosis as confirmed by SCID.
Description

Women with PMDD had no other current Axis I psychiatric diagnosis within the past two years per Structured Clinical Interview for DSM-IV (SCID), while control women had neither current nor past Axis I diagnosis as confirmed by SCID.

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0520676
UMLS CUI [1,3]
C0270287
UMLS CUI [1,4]
C0935589
UMLS CUI [1,5]
C0220952
UMLS CUI [1,6]
C0009932
UMLS CUI [1,7]
C0332122
UMLS CUI [1,8]
C1537054
All women received remuneration according to guidelines from the NIH Healthy Volunteer Office. The study protocol was reviewed and approved by the National Institute of Mental Health Institutional Review Board, and all women gave written informed consent.
Description

All women received remuneration according to guidelines from the NIH Healthy Volunteer Office. The study protocol was reviewed and approved by the National Institute of Mental Health Institutional Review Board, and all women gave written informed consent.

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0162369
UMLS CUI [1,3]
C0162791
UMLS CUI [1,4]
C1708335
UMLS CUI [1,5]
C0027468
UMLS CUI [1,6]
C2348563
UMLS CUI [1,7]
C0027466
UMLS CUI [1,8]
C2347584
UMLS CUI [1,9]
C0811741
*Clinical Hormone Manipulation Protocol:* The hormone manipulation protocol has been previously described (Schmidt et al, NEJM, 1998) and is briefly presented here. All participants received six monthly injections of the GnRH agonist leuprolide acetate, Lupron (3.75 mg IM q monthly). After three months of leuprolide alone, all participants (while continuing to receive monthly leuprolide injections for an additional three months) were randomly assigned in double-blind, crossover fashion to receive either estradiol or progesterone replacement lasting for five weeks each (with a two-week washout between hormone administration periods).
Description

*Clinical Hormone Manipulation Protocol:* The hormone manipulation protocol has been previously described (Schmidt et al, NEJM, 1998) and is briefly presented here. All participants received six monthly injections of the GnRH agonist leuprolide acetate, Lupron (3.75 mg IM q monthly). After three months of leuprolide alone, all participants (while continuing to receive monthly leuprolide injections for an additional three months) were randomly assigned in double-blind, crossover fashion to receive either estradiol or progesterone replacement lasting for five weeks each (with a two-week washout between hormone administration periods).

Data type

boolean

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0586971
UMLS CUI [1,3]
C0678257
UMLS CUI [1,4]
C4554048
UMLS CUI [1,5]
C1272883
UMLS CUI [1,6]
C0700596
UMLS CUI [1,7]
C0034656
UMLS CUI [1,8]
C0013072
UMLS CUI [1,9]
C0014912
UMLS CUI [1,10]
C0033308
UMLS CUI [1,11]
C0444921
UMLS CUI [1,12]
C1710661
We employed this GnRH agonist, ovarian suppression protocol to first confirm the ovarian steroid phenotypes that were the focus of this study; i.e., women with GnRH agonist-induced remission and ovarian steroid-triggered recurrence of PMDD symptoms and those with no mood symptoms during the same hormone manipulation (i.e. control women).
Description

We employed this GnRH agonist, ovarian suppression protocol to first confirm the ovarian steroid phenotypes that were the focus of this study; i.e., women with GnRH agonist-induced remission and ovarian steroid-triggered recurrence of PMDD symptoms and those with no mood symptoms during the same hormone manipulation (i.e. control women).

Data type

boolean

Alias
UMLS CUI [1,1]
C4728041
UMLS CUI [1,2]
C2012324
UMLS CUI [1,3]
C0521091
UMLS CUI [1,4]
C0031437
UMLS CUI [1,5]
C2985879
UMLS CUI [1,6]
C0043210
UMLS CUI [1,7]
C2012324
UMLS CUI [1,8]
C0544452
UMLS CUI [1,9]
C2825055
UMLS CUI [1,10]
C0520676
UMLS CUI [1,11]
C2232697
UMLS CUI [1,12]
C0347984
UMLS CUI [1,13]
C0586971
*Symptom ratings and criteria for response: *Symptom-rating forms were completed daily by all women prior to the study and during the six-month Lupron protocol. Significant recurrence of PMDD symptoms was defined by a weekly average score of greater than three (moderate severity) in irritability, anxiety, or sadness. Controls were defined by absence of affective symptoms throughout the 6 month hormone manipulation protocol (i.e., no weekly average score >2).
Description

*Symptom ratings and criteria for response: *Symptom-rating forms were completed daily by all women prior to the study and during the six-month Lupron protocol. Significant recurrence of PMDD symptoms was defined by a weekly average score of greater than three (moderate severity) in irritability, anxiety, or sadness. Controls were defined by absence of affective symptoms throughout the 6 month hormone manipulation protocol (i.e., no weekly average score >2).

Data type

boolean

Alias
UMLS CUI [1,1]
C0429688
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C4531465
UMLS CUI [1,4]
C1556116
UMLS CUI [1,5]
C0332173
UMLS CUI [1,6]
C0043210
UMLS CUI [1,7]
C5421123
UMLS CUI [1,8]
C0701459
UMLS CUI [1,9]
C2348563
UMLS CUI [1,10]
C2825055
UMLS CUI [1,11]
C0520676
UMLS CUI [1,12]
C1510992
UMLS CUI [1,13]
C0449820
UMLS CUI [1,14]
C4740652
UMLS CUI [1,15]
C0022107
UMLS CUI [1,16]
C0003467
UMLS CUI [1,17]
C3536794
UMLS CUI [1,18]
C0009932
UMLS CUI [1,19]
C0332197
UMLS CUI [1,20]
C0001726
UMLS CUI [1,21]
C0586971
*Selection of participants for generation of lymphoblastoid cell lines (LCLs): *Two main sets of lymphoblastoid cell lines were created for this study: a focus set and a larger replication set. For the focus set, we selected from participants who completed participation in the GnRH agonist-induced hormone manipulation protocol. Group 1 (n=10) consisted of women with PMDD based on suppression of PMDD symptoms during leuprolide treatment and recurrence of symptoms during either the E or P add-back conditions. Group 2 (n=9) consisted of women without PMDD (controls) based on absence of symptoms throughout the entire protocol. Group 1 and Group 2 were matched for age and ethnicity and compared against each other within experimental protocols (no significant differences in Age (t17 =1.3, p=0.03) or BMI (t17=0.2, p=0.8).
Description

*Selection of participants for generation of lymphoblastoid cell lines (LCLs): *Two main sets of lymphoblastoid cell lines were created for this study: a focus set and a larger replication set. For the focus set, we selected from participants who completed participation in the GnRH agonist-induced hormone manipulation protocol. Group 1 (n=10) consisted of women with PMDD based on suppression of PMDD symptoms during leuprolide treatment and recurrence of symptoms during either the E or P add-back conditions. Group 2 (n=9) consisted of women without PMDD (controls) based on absence of symptoms throughout the entire protocol. Group 1 and Group 2 were matched for age and ethnicity and compared against each other within experimental protocols (no significant differences in Age (t17 =1.3, p=0.03) or BMI (t17=0.2, p=0.8).

Data type

boolean

Alias
UMLS CUI [1,1]
C4554048
UMLS CUI [1,2]
C0682526
UMLS CUI [1,3]
C0242802
UMLS CUI [1,4]
C0679823
UMLS CUI [1,5]
C0586971
UMLS CUI [1,6]
C2267072
UMLS CUI [1,7]
C2348563
UMLS CUI [1,8]
C0043210
UMLS CUI [1,9]
C0520676
UMLS CUI [1,10]
C0085272
UMLS CUI [1,11]
C1457887
UMLS CUI [1,12]
C4524105
UMLS CUI [1,13]
C0231221
UMLS CUI [1,14]
C0150103
UMLS CUI [1,15]
C0001779
UMLS CUI [1,16]
C0015031
UMLS CUI [1,17]
C1305855
For the larger replication set, we selected 29 PMDD women (Group 3) and 30 control women (Group 4) who did not necessarily participate in the hormone manipulation protocol. Some women in groups 3 and 4 had participated in the GnRH agonist study, but their participation was not an inclusion criterion. These women underwent the same screening as those in Groups 1 and 2, and completed the DRF to confirm the diagnosis or absence of PMDD according to the DSM V. Thus, Group 3 represents an expanded PMDD phenotype, not necessarily confirmed as hormone-triggered. Nonetheless, we predict based on clinical studies, and observation, that approximately 70% of the women ascertained as PMDD will experience symptom remission with GnRH agonist treatment, and 90% of control women would not develop clinically significant mood symptoms on leuprolide (Lupron). They were also matched for ethnicity, although there was a significant difference in age (t57=4.4, p<0.0001), but not BMI (t57=1.8, p=0.08).
Description

For the larger replication set, we selected 29 PMDD women (Group 3) and 30 control women (Group 4) who did not necessarily participate in the hormone manipulation protocol. Some women in groups 3 and 4 had participated in the GnRH agonist study, but their participation was not an inclusion criterion. These women underwent the same screening as those in Groups 1 and 2, and completed the DRF to confirm the diagnosis or absence of PMDD according to the DSM V. Thus, Group 3 represents an expanded PMDD phenotype, not necessarily confirmed as hormone-triggered. Nonetheless, we predict based on clinical studies, and observation, that approximately 70% of the women ascertained as PMDD will experience symptom remission with GnRH agonist treatment, and 90% of control women would not develop clinically significant mood symptoms on leuprolide (Lupron). They were also matched for ethnicity, although there was a significant difference in age (t57=4.4, p<0.0001), but not BMI (t57=1.8, p=0.08).

Data type

boolean

Alias
UMLS CUI [1,1]
C1883725
UMLS CUI [1,2]
C0520676
UMLS CUI [1,3]
C0043210
UMLS CUI [1,4]
C0009932
UMLS CUI [1,5]
C1706256
UMLS CUI [1,6]
C0586971
UMLS CUI [1,7]
C2348563
UMLS CUI [1,8]
C2267072
UMLS CUI [1,9]
C5418626
UMLS CUI [1,10]
C0220908
UMLS CUI [1,11]
C0521091
UMLS CUI [1,12]
C0011900
UMLS CUI [1,13]
C1137105
UMLS CUI [1,14]
C0031437
UMLS CUI [1,15]
C0681842
UMLS CUI [1,16]
C0008972
UMLS CUI [1,17]
C0700325
UMLS CUI [1,18]
C2985739
UMLS CUI [1,19]
C2232697
UMLS CUI [1,20]
C0150103
UMLS CUI [1,21]
C0015031
UMLS CUI [1,22]
C0001779
UMLS CUI [1,23]
C1305855
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Similar models

Eligibility Criteria

5 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
*Participant Selection:*
Item
*Participant Selection:*
boolean
C0679646 (UMLS CUI [1,1])
C1707391 (UMLS CUI [1,2])
Women between the ages of 18 and 48 years who were medication-free, with regular menstrual cycles (range, 21 to 35 days), not medically ill and not pregnant were included in the clinical study.
Item
Women between the ages of 18 and 48 years who were medication-free, with regular menstrual cycles (range, 21 to 35 days), not medically ill and not pregnant were included in the clinical study.
boolean
C0043210 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C2229012 (UMLS CUI [1,5])
C3898900 (UMLS CUI [1,6])
C0232973 (UMLS CUI [1,7])
C0008972 (UMLS CUI [1,8])
Women with PMDD were self-referred in response to newspaper advertisements or were referred by their physician. The diagnosis of PMDD was confirmed prospectively prior to enter into this study by self-administered symptom ratings (a 100mm visual analog scale) completed daily over three consecutive menstrual cycles. In addition to meeting DSM IV criteria for PMDD, each woman had an increase of at least 30 percent (relative to the range of the scale she used) in average self-ratings of negative moods (irritability, depression, anxiety, and mood stability) in the seven days before menses compared with the ratings for the seven days after the end of menses, in at least two of the three baseline cycles. These are more stringent criteria than those of DSM-IV or V.
Item
Women with PMDD were self-referred in response to newspaper advertisements or were referred by their physician. The diagnosis of PMDD was confirmed prospectively prior to enter into this study by self-administered symptom ratings (a 100mm visual analog scale) completed daily over three consecutive menstrual cycles. In addition to meeting DSM IV criteria for PMDD, each woman had an increase of at least 30 percent (relative to the range of the scale she used) in average self-ratings of negative moods (irritability, depression, anxiety, and mood stability) in the seven days before menses compared with the ratings for the seven days after the end of menses, in at least two of the three baseline cycles. These are more stringent criteria than those of DSM-IV or V.
boolean
C0043210 (UMLS CUI [1,1])
C0520676 (UMLS CUI [1,2])
C3266254 (UMLS CUI [1,3])
C0949214 (UMLS CUI [1,4])
C2911692 (UMLS CUI [1,5])
C3266257 (UMLS CUI [1,6])
C0521091 (UMLS CUI [1,7])
C0011900 (UMLS CUI [1,8])
C5421123 (UMLS CUI [1,9])
C0429688 (UMLS CUI [1,10])
C0025329 (UMLS CUI [1,11])
C0220952 (UMLS CUI [1,12])
C0243161 (UMLS CUI [1,13])
C0205217 (UMLS CUI [1,14])
C1510992 (UMLS CUI [1,15])
C0026516 (UMLS CUI [1,16])
C0022107 (UMLS CUI [1,17])
C0011570 (UMLS CUI [1,18])
C0003467 (UMLS CUI [1,19])
C0558224 (UMLS CUI [1,20])
C0332152 (UMLS CUI [1,21])
C0025344 (UMLS CUI [1,22])
C0231290 (UMLS CUI [1,23])
Women without PMDD (control women) were recruited, and studied, in parallel. Absence of premenstrual mood symptoms was confirmed using the same daily rating scales during a two-month baseline period.
Item
Women without PMDD (control women) were recruited, and studied, in parallel. Absence of premenstrual mood symptoms was confirmed using the same daily rating scales during a two-month baseline period.
boolean
C0043210 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0520676 (UMLS CUI [1,3])
C0009932 (UMLS CUI [1,4])
C2826345 (UMLS CUI [1,5])
C0332197 (UMLS CUI [1,6])
C0521091 (UMLS CUI [1,7])
C0232959 (UMLS CUI [1,8])
C2232697 (UMLS CUI [1,9])
C0681889 (UMLS CUI [1,10])
C1442488 (UMLS CUI [1,11])
Women with PMDD had no other current Axis I psychiatric diagnosis within the past two years per Structured Clinical Interview for DSM-IV (SCID), while control women had neither current nor past Axis I diagnosis as confirmed by SCID.
Item
Women with PMDD had no other current Axis I psychiatric diagnosis within the past two years per Structured Clinical Interview for DSM-IV (SCID), while control women had neither current nor past Axis I diagnosis as confirmed by SCID.
boolean
C0043210 (UMLS CUI [1,1])
C0520676 (UMLS CUI [1,2])
C0270287 (UMLS CUI [1,3])
C0935589 (UMLS CUI [1,4])
C0220952 (UMLS CUI [1,5])
C0009932 (UMLS CUI [1,6])
C0332122 (UMLS CUI [1,7])
C1537054 (UMLS CUI [1,8])
All women received remuneration according to guidelines from the NIH Healthy Volunteer Office. The study protocol was reviewed and approved by the National Institute of Mental Health Institutional Review Board, and all women gave written informed consent.
Item
All women received remuneration according to guidelines from the NIH Healthy Volunteer Office. The study protocol was reviewed and approved by the National Institute of Mental Health Institutional Review Board, and all women gave written informed consent.
boolean
C0043210 (UMLS CUI [1,1])
C0162369 (UMLS CUI [1,2])
C0162791 (UMLS CUI [1,3])
C1708335 (UMLS CUI [1,4])
C0027468 (UMLS CUI [1,5])
C2348563 (UMLS CUI [1,6])
C0027466 (UMLS CUI [1,7])
C2347584 (UMLS CUI [1,8])
C0811741 (UMLS CUI [1,9])
*Clinical Hormone Manipulation Protocol:* The hormone manipulation protocol has been previously described (Schmidt et al, NEJM, 1998) and is briefly presented here. All participants received six monthly injections of the GnRH agonist leuprolide acetate, Lupron (3.75 mg IM q monthly). After three months of leuprolide alone, all participants (while continuing to receive monthly leuprolide injections for an additional three months) were randomly assigned in double-blind, crossover fashion to receive either estradiol or progesterone replacement lasting for five weeks each (with a two-week washout between hormone administration periods).
Item
*Clinical Hormone Manipulation Protocol:* The hormone manipulation protocol has been previously described (Schmidt et al, NEJM, 1998) and is briefly presented here. All participants received six monthly injections of the GnRH agonist leuprolide acetate, Lupron (3.75 mg IM q monthly). After three months of leuprolide alone, all participants (while continuing to receive monthly leuprolide injections for an additional three months) were randomly assigned in double-blind, crossover fashion to receive either estradiol or progesterone replacement lasting for five weeks each (with a two-week washout between hormone administration periods).
boolean
C0008971 (UMLS CUI [1,1])
C0586971 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C4554048 (UMLS CUI [1,4])
C1272883 (UMLS CUI [1,5])
C0700596 (UMLS CUI [1,6])
C0034656 (UMLS CUI [1,7])
C0013072 (UMLS CUI [1,8])
C0014912 (UMLS CUI [1,9])
C0033308 (UMLS CUI [1,10])
C0444921 (UMLS CUI [1,11])
C1710661 (UMLS CUI [1,12])
We employed this GnRH agonist, ovarian suppression protocol to first confirm the ovarian steroid phenotypes that were the focus of this study; i.e., women with GnRH agonist-induced remission and ovarian steroid-triggered recurrence of PMDD symptoms and those with no mood symptoms during the same hormone manipulation (i.e. control women).
Item
We employed this GnRH agonist, ovarian suppression protocol to first confirm the ovarian steroid phenotypes that were the focus of this study; i.e., women with GnRH agonist-induced remission and ovarian steroid-triggered recurrence of PMDD symptoms and those with no mood symptoms during the same hormone manipulation (i.e. control women).
boolean
C4728041 (UMLS CUI [1,1])
C2012324 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,3])
C0031437 (UMLS CUI [1,4])
C2985879 (UMLS CUI [1,5])
C0043210 (UMLS CUI [1,6])
C2012324 (UMLS CUI [1,7])
C0544452 (UMLS CUI [1,8])
C2825055 (UMLS CUI [1,9])
C0520676 (UMLS CUI [1,10])
C2232697 (UMLS CUI [1,11])
C0347984 (UMLS CUI [1,12])
C0586971 (UMLS CUI [1,13])
*Symptom ratings and criteria for response: *Symptom-rating forms were completed daily by all women prior to the study and during the six-month Lupron protocol. Significant recurrence of PMDD symptoms was defined by a weekly average score of greater than three (moderate severity) in irritability, anxiety, or sadness. Controls were defined by absence of affective symptoms throughout the 6 month hormone manipulation protocol (i.e., no weekly average score >2).
Item
*Symptom ratings and criteria for response: *Symptom-rating forms were completed daily by all women prior to the study and during the six-month Lupron protocol. Significant recurrence of PMDD symptoms was defined by a weekly average score of greater than three (moderate severity) in irritability, anxiety, or sadness. Controls were defined by absence of affective symptoms throughout the 6 month hormone manipulation protocol (i.e., no weekly average score >2).
boolean
C0429688 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C4531465 (UMLS CUI [1,3])
C1556116 (UMLS CUI [1,4])
C0332173 (UMLS CUI [1,5])
C0043210 (UMLS CUI [1,6])
C5421123 (UMLS CUI [1,7])
C0701459 (UMLS CUI [1,8])
C2348563 (UMLS CUI [1,9])
C2825055 (UMLS CUI [1,10])
C0520676 (UMLS CUI [1,11])
C1510992 (UMLS CUI [1,12])
C0449820 (UMLS CUI [1,13])
C4740652 (UMLS CUI [1,14])
C0022107 (UMLS CUI [1,15])
C0003467 (UMLS CUI [1,16])
C3536794 (UMLS CUI [1,17])
C0009932 (UMLS CUI [1,18])
C0332197 (UMLS CUI [1,19])
C0001726 (UMLS CUI [1,20])
C0586971 (UMLS CUI [1,21])
*Selection of participants for generation of lymphoblastoid cell lines (LCLs): *Two main sets of lymphoblastoid cell lines were created for this study: a focus set and a larger replication set. For the focus set, we selected from participants who completed participation in the GnRH agonist-induced hormone manipulation protocol. Group 1 (n=10) consisted of women with PMDD based on suppression of PMDD symptoms during leuprolide treatment and recurrence of symptoms during either the E or P add-back conditions. Group 2 (n=9) consisted of women without PMDD (controls) based on absence of symptoms throughout the entire protocol. Group 1 and Group 2 were matched for age and ethnicity and compared against each other within experimental protocols (no significant differences in Age (t17 =1.3, p=0.03) or BMI (t17=0.2, p=0.8).
Item
*Selection of participants for generation of lymphoblastoid cell lines (LCLs): *Two main sets of lymphoblastoid cell lines were created for this study: a focus set and a larger replication set. For the focus set, we selected from participants who completed participation in the GnRH agonist-induced hormone manipulation protocol. Group 1 (n=10) consisted of women with PMDD based on suppression of PMDD symptoms during leuprolide treatment and recurrence of symptoms during either the E or P add-back conditions. Group 2 (n=9) consisted of women without PMDD (controls) based on absence of symptoms throughout the entire protocol. Group 1 and Group 2 were matched for age and ethnicity and compared against each other within experimental protocols (no significant differences in Age (t17 =1.3, p=0.03) or BMI (t17=0.2, p=0.8).
boolean
C4554048 (UMLS CUI [1,1])
C0682526 (UMLS CUI [1,2])
C0242802 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0586971 (UMLS CUI [1,5])
C2267072 (UMLS CUI [1,6])
C2348563 (UMLS CUI [1,7])
C0043210 (UMLS CUI [1,8])
C0520676 (UMLS CUI [1,9])
C0085272 (UMLS CUI [1,10])
C1457887 (UMLS CUI [1,11])
C4524105 (UMLS CUI [1,12])
C0231221 (UMLS CUI [1,13])
C0150103 (UMLS CUI [1,14])
C0001779 (UMLS CUI [1,15])
C0015031 (UMLS CUI [1,16])
C1305855 (UMLS CUI [1,17])
For the larger replication set, we selected 29 PMDD women (Group 3) and 30 control women (Group 4) who did not necessarily participate in the hormone manipulation protocol. Some women in groups 3 and 4 had participated in the GnRH agonist study, but their participation was not an inclusion criterion. These women underwent the same screening as those in Groups 1 and 2, and completed the DRF to confirm the diagnosis or absence of PMDD according to the DSM V. Thus, Group 3 represents an expanded PMDD phenotype, not necessarily confirmed as hormone-triggered. Nonetheless, we predict based on clinical studies, and observation, that approximately 70% of the women ascertained as PMDD will experience symptom remission with GnRH agonist treatment, and 90% of control women would not develop clinically significant mood symptoms on leuprolide (Lupron). They were also matched for ethnicity, although there was a significant difference in age (t57=4.4, p<0.0001), but not BMI (t57=1.8, p=0.08).
Item
For the larger replication set, we selected 29 PMDD women (Group 3) and 30 control women (Group 4) who did not necessarily participate in the hormone manipulation protocol. Some women in groups 3 and 4 had participated in the GnRH agonist study, but their participation was not an inclusion criterion. These women underwent the same screening as those in Groups 1 and 2, and completed the DRF to confirm the diagnosis or absence of PMDD according to the DSM V. Thus, Group 3 represents an expanded PMDD phenotype, not necessarily confirmed as hormone-triggered. Nonetheless, we predict based on clinical studies, and observation, that approximately 70% of the women ascertained as PMDD will experience symptom remission with GnRH agonist treatment, and 90% of control women would not develop clinically significant mood symptoms on leuprolide (Lupron). They were also matched for ethnicity, although there was a significant difference in age (t57=4.4, p<0.0001), but not BMI (t57=1.8, p=0.08).
boolean
C1883725 (UMLS CUI [1,1])
C0520676 (UMLS CUI [1,2])
C0043210 (UMLS CUI [1,3])
C0009932 (UMLS CUI [1,4])
C1706256 (UMLS CUI [1,5])
C0586971 (UMLS CUI [1,6])
C2348563 (UMLS CUI [1,7])
C2267072 (UMLS CUI [1,8])
C5418626 (UMLS CUI [1,9])
C0220908 (UMLS CUI [1,10])
C0521091 (UMLS CUI [1,11])
C0011900 (UMLS CUI [1,12])
C1137105 (UMLS CUI [1,13])
C0031437 (UMLS CUI [1,14])
C0681842 (UMLS CUI [1,15])
C0008972 (UMLS CUI [1,16])
C0700325 (UMLS CUI [1,17])
C2985739 (UMLS CUI [1,18])
C2232697 (UMLS CUI [1,19])
C0150103 (UMLS CUI [1,20])
C0015031 (UMLS CUI [1,21])
C0001779 (UMLS CUI [1,22])
C1305855 (UMLS CUI [1,23])
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