Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety) - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001770

Purpose

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?

Condition
Depressive Disorder Mood Disorder Psychomotor Agitation

MedlinePlus related topics: Anxiety Depression Hormone Replacement Therapy

Drug Information available for: Progesterone

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Phenomenology and Biophysiology of Progestin-Induced Dysphoria

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	50
Study Start Date:	March 1998
Estimated Study Completion Date:	March 2003

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?

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001770

Locations

United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Publications:

Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry. 1996 Apr;57(4):152-7.

Smith RN, Holland EF, Studd JW. The symptomatology of progestogen intolerance. Maturitas. 1994 Feb;18(2):87-91.

Magos 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.

Study ID Numbers:	980079, 98-M-0079
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001770
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Depression
Estrogen
Hormone Replacement Therapy
Mood

Progestin
Progesterone
Anxiety

Study placed in the following topic categories:

Signs and Symptoms
Depression
Progesterone
Mental Disorders
Mood Disorders
Neurologic Manifestations

Psychomotor Agitation
Depressive Disorder
Neurobehavioral Manifestations
Dyskinesias
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Progestins
Physiological Effects of Drugs
Nervous System Diseases

Hormones, Hormone Substitutes, and Hormone Antagonists
Psychomotor Disorders
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009