Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	04-M-0139
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Female Min Age: 30 Max Age: 50
Referral Letter Required	No
Population Exclusion(s)	Male; Children
Special Instructions	Currently Not Provided
Keywords	Neurosteroids; 5 Alpha-Reductase Inhibitor; Depression; Menstrual Cycle; Gonadal Steroids
Recruitment Keyword(s)	Menstrual Cycle; Depression; Menstrual Cycle Related Mood Disorder; MRMD; Healthy Volunteer
Condition(s)	Premenstrual Syndrome; PMS; Healthy; Depression
Investigational Drug(s)	Dutasteride
Investigational Device(s)	None
Intervention(s)	Drug: Dutasteride Drug: Placebo oral capsule
Supporting Site	National Institute of Mental Health

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.

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Eligibility

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 30-50 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 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:

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 or drug abuse or dependence;

6) 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);

7) Male gender;

8) Age less than 30 years; and

9) 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.

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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.

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.

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

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Contacts:

Principal Investigator	Referral Contact	For more information:
Pedro E. Martinez, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room 4C436 10 Center Drive Bethesda, Maryland 20892 (301) 402-0615 martinep@mail.nih.gov	Pedro E. Martinez, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room 4C436 10 Center Drive Bethesda, Maryland 20892 (301) 496-5831 martinep@mail.nih.gov	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 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00082043

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