Depressive DisorderNCT00001770
Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)
An observational study of Depressive Disorder and Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause. Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Mood Disorder, Psychomotor Agitation
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Mar 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The subjects in this study will be women who meet the following criteria:
- history of mood and/or behavioral symptoms associated with hormone replacement therapy;
- age 40 to 65;
- in good medical health.
Who cannot join
- Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not participate in this protocol. Additionally prior to participation all subjects will be examined for any contradictions to estrogen therapy (as determined by a pelvic exam and mammogram) within the past year by a gynecologist of their choice. In those patients who are unable to independently arrange this exam, we have arranged for a consultant gynecologist to be available through our collaboration with NICHD.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: The Phenomenology and Biophysiology of Progestin-Induced Dysphoria
Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause.
Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk of uterine cancer. The progesterone component of the HRT (progestin) works to prevent the increased risk of uterine cancer.
Read more
There is evidence that some women experience unpleasant mood symptoms (such as irritability, depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking the progestin / progesterone component of the HRT.
This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women. Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home.
This research will attempt to answer the following questions:
- Are progestins associated with changes in mood during hormone replacement therapy?
- If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
Read the detailed description
There is evidence in the literature that some women experience dysphoric symptoms while receiving hormone replacement therapy (HRT) and that this disturbance in mood is related to the progestin component of the HRT. The bulk of this evidence is anecdotal. While some authors have attempted to examine this putative problem in a more systematic fashion, there are no controlled studies that attempt to identify the mechanism through which the perturbation in mood occurs. Adverse effects of progestins might be mediated directly through the progesterone or androgen receptor. Alternatively, the effects of progestins might be consequent to the antiestrogen effects of progesterone. This latter possibility is in part supported by our observation in previous studies of the beneficial effects of estradiol on mood and the possible precipitation of mood disturbance following acute estrogen withdrawal. Finally, despite the popular lore that progesterone causes mood disturbances, a placebo effect cannot be ruled out, since women taking HRT know when they are receiving the progestin component of the regimen. Our research questions therefore are as follows: 1) Are progestins associated with changes in mood during HRT, and 2) If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
- Conditions
- Depressive Disorder, Mood Disorder, Psychomotor Agitation
- Keywords
- Depression, Estrogen, Hormone Replacement Therapy, Mood, Progestin, Progesterone, Anxiety
- Medical subject headings
- Depressive Disorder, Mood Disorders, Psychomotor Agitation, Depression, Anxiety Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMar 1998
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001770
- Sponsor's protocol ID
- 980079
- Other IDs
- 98-M-0079
- Status last verified
- Mar 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry. 1996 Apr;57(4):152-7.
PubMed 8601550Smith RN, Holland EF, Studd JW. The symptomatology of progestogen intolerance. Maturitas. 1994 Feb;18(2):87-91. doi: 10.1016/0378-5122(94)90046-9.
PubMed 8177097Magos AL, Brewster E, Singh R, O'Dowd T, Brincat M, Studd JW. The effects of norethisterone in postmenopausal women on oestrogen replacement therapy: a model for the premenstrual syndrome. Br J Obstet Gynaecol. 1986 Dec;93(12):1290-6. doi: 10.1111/j.1471-0528.1986.tb07868.x.
PubMed 3801360
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phenomenology and Biophysiology of Progestin-Induced Dysphoria
- ClinicalTrials.gov ID
- NCT00001770
- Acronym / sponsor ID
- 980079
- Conditions
- Depressive Disorder, Mood Disorder, Psychomotor Agitation
- Keywords
- Depression, Estrogen, Hormone Replacement Therapy, Mood, Progestin, Progesterone, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Mar 1998
- Study completion
- Mar 2003
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause.
Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk of uterine cancer. The progesterone component of the HRT (progestin) works to prevent the increased risk of uterine cancer.
There is evidence that some women experience unpleasant mood symptoms (such as irritability, depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking the progestin / progesterone component of the HRT.
This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women. Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home.
This research will attempt to answer the following questions:
- Are progestins associated with changes in mood during hormone replacement therapy?
- If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
Detailed description
There is evidence in the literature that some women experience dysphoric symptoms while receiving hormone replacement therapy (HRT) and that this disturbance in mood is related to the progestin component of the HRT. The bulk of this evidence is anecdotal. While some authors have attempted to examine this putative problem in a more systematic fashion, there are no controlled studies that attempt to identify the mechanism through which the perturbation in mood occurs. Adverse effects of progestins might be mediated directly through the progesterone or androgen receptor. Alternatively, the effects of progestins might be consequent to the antiestrogen effects of progesterone. This latter possibility is in part supported by our observation in previous studies of the beneficial effects of estradiol on mood and the possible precipitation of mood disturbance following acute estrogen withdrawal. Finally, despite the popular lore that progesterone causes mood disturbances, a placebo effect cannot be ruled out, since women taking HRT know when they are receiving the progestin component of the regimen. Our research questions therefore are as follows: 1) Are progestins associated with changes in mood during HRT, and 2) If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- history of mood and/or behavioral symptoms associated with hormone replacement therapy;
- age 40 to 65;
- in good medical health.
Key exclusion criteria (1 listed)
- Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not participate in this protocol. Additionally prior to participation all subjects will be examined for any contradictions to estrogen therapy (as determined by a pelvic exam and mammogram) within the past year by a gynecologist of their choice. In those patients who are unable to independently arrange this exam, we have arranged for a consultant gynecologist to be available through our collaboration with NICHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8601550Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry. 1996 Apr;57(4):152-7.
- Background: PubMed 8177097Smith RN, Holland EF, Studd JW. The symptomatology of progestogen intolerance. Maturitas. 1994 Feb;18(2):87-91. doi: 10.1016/0378-5122(94)90046-9.
- Background: PubMed 3801360Magos AL, Brewster E, Singh R, O'Dowd T, Brincat M, Studd JW. The effects of norethisterone in postmenopausal women on oestrogen replacement therapy: a model for the premenstrual syndrome. Br J Obstet Gynaecol. 1986 Dec;93(12):1290-6. doi: 10.1111/j.1471-0528.1986.tb07868.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001770, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.