Protocol Number: 04-M-0139

Title:

The Effects of Dutasteride on Mood, HPA Axis, and Serum Allopregnanolone Levels in Women with Menstrual-Related Mood Disorders and Controls

Number:

04-M-0139

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 response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men.

Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up.

Participants undergo the following tests and procedures:

- Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo.

- Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings.

- Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

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:

1) 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;

2) 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;

3) Age 30-45 years;

4) In good physical health;

5) 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 45, 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:

1) Pregnancy or any intent to become pregnant;

2) Medical illness, in particular diabetes, cardiac or renal disease;

3) Use of psychotropic or hormonal medications within three months prior to the study;

4) Current prescription medication use;

5) History of or current alcohol abuse or dependence;

6) A history of (within the past two years) or current psychiatric disorder determined by administration of the Schedule for Affective Disorders and Schizophrenia-Lifetime Version (SCID);

7) Male gender; and

8) Age less than 30 years.

9) Subjects who abuse drugs other than alcohol.

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.

Special Instructions: Currently Not Provided

Keywords:

Neurosteroids

5 Alpha-Reductase Inhibitor

Depression

Menstrual Cycle

Gonadal Steroids

Recruitment Keywords:

Menstrual Cycle

Depression

Menstrual Cycle Related Mood Disorder

MRMD

Healthy Volunteer

Conditions:

Premenstrual Syndrome

Investigational Drug(s):

Dutasteride

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Halbreich U, Borenstein J, Pearlstein T, Kahn LS. The prevalence, impairment, impact, and burden of premenstrual dysphoric disorder (PMS/PMDD). Psychoneuroendocrinology. 2003 Aug;28 Suppl 3:1-23. Review. PMID: 12892987

Wittchen HU, Becker E, Lieb R, Krause P. Prevalence, incidence and stability of premenstrual dysphoric disorder in the community. Psychol Med. 2002 Jan;32(1):119-32. PMID: 11883723

Rubinow DR, Roy-Byrne P. Premenstrual syndromes: overview from a methodologic perspective. Am J Psychiatry. 1984 Feb;141(2):163-72. Review. PMID: 6362441

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