Trial Outcomes & Findings for The Role of Hormones in Postpartum Mood Disorders (NCT NCT00001481)
NCT ID: NCT00001481
Last Updated: 2025-12-05
Results Overview
The Edinburgh Postnatal Depression Scale (EPDS) is a self-reported 10 item questionnaire to asses a participant's mood over the past week. Each question has four possible answers, scored from 0 to 3 with total score ranging from 0 to 30. Higher scores indicate more severe mood symptoms. EPDS was administered once every 2 weeks for the duration of the study. Analysis was calculated as the mean of scores for baseline (week 16) and weeks 18 and 20.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Weeks 16, 18, and 20
Results posted on
2025-12-05
Participant Flow
74 participants were consented: * 21 participants were screen failure * 2 participants withdrew after signing consent * 4 participants dropped out prior to randomization * 1 participant dropped out after randomization and prior to start of intervention * 46 participants were randomized and received study intervention
Participant milestones
| Measure |
Arm 1a - Postpartum Depression: Hormone Withdrawal
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1b - Depression, Non-reproductive: Hormone Withdrawal
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1c - Healthy Volunteer: Hormone Withdrawal
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 2a - Postpartum Depression: Hormone Continuation
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2b - Depression, Non-reproductive: Hormone Continuation
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2c - Healthy Volunteer: Hormone Continuation
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
|---|---|---|---|---|---|---|
|
Study 1
STARTED
|
7
|
0
|
8
|
0
|
0
|
0
|
|
Study 1
COMPLETED
|
7
|
0
|
8
|
0
|
0
|
0
|
|
Study 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Study 2
STARTED
|
9
|
1
|
5
|
7
|
2
|
7
|
|
Study 2
COMPLETED
|
9
|
1
|
5
|
7
|
2
|
7
|
|
Study 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Hormones in Postpartum Mood Disorders
Baseline characteristics by cohort
| Measure |
Arm 1a - Postpartum Depression: Hormone Withdrawal Group
n=16 Participants
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1b - Depression, Non-reproductive: Hormone Withdrawal Group
n=1 Participants
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1c- Healthy Volunteer: Hormone Withdrawal Group
n=13 Participants
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 2a: Postpartum Depression; Hormone Continuation Group
n=7 Participants
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2b - Depression, Non-reproductive: Hormone Continuation Group
n=2 Participants
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2c- Healthy Volunteer: Hormone Continuation Group
n=7 Participants
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
13 Participants
n=74 Participants
|
5 Participants
n=267 Participants
|
2 Participants
n=272 Participants
|
7 Participants
n=6 Participants
|
41 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
13 Participants
n=74 Participants
|
7 Participants
n=267 Participants
|
2 Participants
n=272 Participants
|
7 Participants
n=6 Participants
|
46 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
6 Participants
n=267 Participants
|
2 Participants
n=272 Participants
|
7 Participants
n=6 Participants
|
43 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
7 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=272 Participants
|
4 Participants
n=6 Participants
|
16 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
4 Participants
n=267 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=6 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Weeks 16, 18, and 20Population: Analysis applies to participants in study 2. Two participants did not complete rating in week 16. One participant did not complete rating in week 18. Two participants did not complete rating in week 20.
The Edinburgh Postnatal Depression Scale (EPDS) is a self-reported 10 item questionnaire to asses a participant's mood over the past week. Each question has four possible answers, scored from 0 to 3 with total score ranging from 0 to 30. Higher scores indicate more severe mood symptoms. EPDS was administered once every 2 weeks for the duration of the study. Analysis was calculated as the mean of scores for baseline (week 16) and weeks 18 and 20.
Outcome measures
| Measure |
Arm 1a - Postpartum Depression: Hormone Withdrawal
n=9 Participants
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1b - Depression, Non-reproductive: Hormone Withdrawal
n=1 Participants
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1c - Healthy Volunteer: Hormone Withdrawal
n=5 Participants
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 2a - Postpartum Depression: Hormone Continuation
n=7 Participants
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2b - Depression, Non-reproductive: Hormone Continuation
n=2 Participants
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2c - Healthy Volunteer: Hormone Continuation
n=7 Participants
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
|---|---|---|---|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) Mean Total Score
Week 16
|
3.75 Units on a scale
Standard Deviation 6.32
|
3 Units on a scale
Standard Deviation NA
Standard Deviation is not calculable for one participant
|
0 Units on a scale
Standard Deviation 0
|
1.14 Units on a scale
Standard Deviation 1.07
|
0.5 Units on a scale
Standard Deviation 0.71
|
0.67 Units on a scale
Standard Deviation 1.21
|
|
Edinburgh Postnatal Depression Scale (EPDS) Mean Total Score
Week 18
|
1.22 Units on a scale
Standard Deviation 3.31
|
0 Units on a scale
Standard Deviation NA
Standard Deviation is not calculable for one participant
|
0 Units on a scale
Standard Deviation 0
|
2.29 Units on a scale
Standard Deviation 2.36
|
0 Units on a scale
Standard Deviation NA
Standard Deviation is not calculable for one participant
|
0.29 Units on a scale
Standard Deviation 0.49
|
|
Edinburgh Postnatal Depression Scale (EPDS) Mean Total Score
Week 20
|
1 Units on a scale
Standard Deviation 1.93
|
0 Units on a scale
Standard Deviation NA
Standard Deviation is not calculable for one participant
|
0.2 Units on a scale
Standard Deviation 0.45
|
3.71 Units on a scale
Standard Deviation 4.54
|
0.5 Units on a scale
Standard Deviation 0.71
|
0.67 Units on a scale
Standard Deviation 0.82
|
Adverse Events
Arm 1a - Postpartum Depression: Hormone Withdrawal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1b - Depression, Non-reproductive: Hormone Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 1c - Healthy Volunteer: Hormone Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2a - Postpartum Depression: Hormone Continuation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2b - Depression, Non-reproductive: Hormone Continuation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2c - Healthy Volunteer: Hormone Continuation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1a - Postpartum Depression: Hormone Withdrawal
n=16 participants at risk
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1b - Depression, Non-reproductive: Hormone Withdrawal
n=1 participants at risk
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 1c - Healthy Volunteer: Hormone Withdrawal
n=13 participants at risk
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 15, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily. During weeks 16 through 20, all participants received placebo capsules to be taken twice daily.
|
Arm 2a - Postpartum Depression: Hormone Continuation
n=7 participants at risk
Female participants with history of postpartum depression (PPD) received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2b - Depression, Non-reproductive: Hormone Continuation
n=2 participants at risk
Female participants with history of non-reproductive related depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
Arm 2c - Healthy Volunteer: Hormone Continuation
n=7 participants at risk
Female participants without history of depression received 3.75 mg of gonadotropin releasing hormone (GnRH) agonist leuprolide acetate (Lupron) via intramuscular injection on a monthly basis for five months (20 weeks), administered during visit for weeks 0, 4, 8, 12, \& 16. Participants received oral capsules twice daily under single blind conditions for the same 5 months (20 weeks). During weeks 0 through 7, all participants received placebo via oral capsule twice daily. During weeks 8 through 20, all participants received 2 mg of 17 beta-estradiol via oral capsule twice daily and 200 mg of progesterone via oral capsule twice daily.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
|
General disorders
Fatigue
|
6.2%
1/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
14.3%
1/7 • Up to 28 weeks from start of study
|
|
Infections and infestations
Corona virus infection
|
6.2%
1/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
|
Investigations
Haemoglobin decreased
|
6.2%
1/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
|
Nervous system disorders
Insomnia
|
0.00%
0/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
14.3%
1/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
|
Nervous system disorders
Sedation
|
0.00%
0/16 • Up to 28 weeks from start of study
|
0.00%
0/1 • Up to 28 weeks from start of study
|
0.00%
0/13 • Up to 28 weeks from start of study
|
0.00%
0/7 • Up to 28 weeks from start of study
|
0.00%
0/2 • Up to 28 weeks from start of study
|
14.3%
1/7 • Up to 28 weeks from start of study
|
Additional Information
Dr. Peter Schmidt
National Institute of Mental Health (NIMH)
Phone: +1 301 496 6120
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place