Status:
COMPLETED
Dutasteride to Treat Women With Menstrually Related Mood Disorders
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Premenstrual Syndrome
PMS
Eligibility:
FEMALE
30-50 years
Phase:
PHASE1
Brief Summary
This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress res...
Detailed Description
Studies of premenstrual syndrome (PMS) to date have demonstrated that the syndrome represents an abnormal response to normal physiological events. Specifically patients with PMS experience a dysphoric...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy controls and women who meet the criteria for MRMD.
- The criteria for MRMD, from Protocol 81-M-126, "The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders," briefly are as follows:
- History within the last two years of at least six months with menstrually-related mood or behavioral disturbances of a severity sufficient to cause at least moderate subjective distress;
- Symptoms should have a sudden onset and offset, with symptoms most severe during the week prior to menstruation and tending to disappear abruptly on or about the first day menstruation;
- Age 30-50 years;
- In good physical health;
- To qualify for study inclusion, women with MRMD will have prospectively demonstrated in at least two of three menstrual cycles a 30% worsening of mean negative mood symptoms in the premenstrual period compared to the week following menses, corrected for the range of the scales employed.
- Healthy controls will have no symptoms of MRMD (confirmed prospectively), be between the ages of 30 and 50, and be in good physical health.
- In addition all subjects will have a normal clinical breast exam prior to study entry.
- EXCLUSION CRITERIA:
- Subjects will be excluded from the study for the following reasons:
- Pregnancy or any intent to become pregnant;
- Medical illness, in particular diabetes, cardiac or renal disease;
- Use of psychotropic or hormonal medications within three months prior to the study;
- Current prescription medication use;
- History of or current alcohol or drug abuse or dependence;
- A history of (within the past two years) or current psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID);
- Male gender;
- Age less than 30 years; and
- Women with a history of carcinoma of the breast, or women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with a history of postmenopausal breast cancer.
- In addition to the above, due to the long half life of dutasteride and its teratogenic effects on male fetuses, only women who have already decided to discontinue child-bearing and are willing to continue barrier contraception for 6 months after the study will be included in the protocol.
Exclusion
Key Trial Info
Start Date :
March 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00082043
Start Date
March 31 2004
End Date
March 6 2014
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892