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Combined Hormone Replacement in Menstrually-Related Mood Disorders
This study is currenly Recruiting patients.
Sponsored by:
National Institute of Mental Health (NIMH)
Purpose
This study investigates the effects on symptoms of combined treatment with estrogen and
progesterone in women with severe premenstrual syndrome (PMDD).
Studies indicate that women with PMS experience improvement in symptoms following treatment
with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but
not women without the disorder, experience a return of symptoms within approximately a week
after re-exposure to either estrogen or progesterone. The cause of this hormone-induced
depression remains unclear. It is not known whether this depressed mood is due simply to the
change in the levels of estrogen and progesterone and whether it would remit following
continued exposure to stable levels of estrogen and progesterone. This study will determine
whether the maintenance of stable hormone levels will prevent mood disturbances in women
with PMS.
Participants in this study will receive leuprolide acetate injections once a month for up to
6 months. After 2 months, women whose symptoms have improved will receive a skin patch
containing either estrogen or placebo (an inactive substance) and will be asked to take
daily suppositories containing either progesterone or placebo. Women whose symptoms of PMS
do not respond to leuprolide treatment after 2 months will end the study and be offered
other treatment. Participants will be seen by a nurse in the clinic every two weeks and will
fill out ratings and have blood drawn to measure hormone levels.
...
Study Type: Treatment
| Condition | Treatment | Phase |
|
Premenstrual Syndrome Depression |
None | N/A |
Study Design:N/A
Official Title: The Treatment of Menstrually-Related Mood Disorders With Continuous Gonadal Steroid Replacement
Further Study Details:
Expected Total Enrollment:
Study Dates:March 2000 -
Results from previous protocols (#90-M-0088 and 92-M-0174) have demonstrated that women
with menstrually-related mood disorder (MRMD), but not women lacking this disorder,
experience mood deterioration within approximately a week after exposure to either estradiol
or progesterone in the context of gonadal suppression (induced by use of the depot
gonadotropin releasing hormone agonist, leuprolide acetate). It is unknown whether this
hormone-induced depression occurs consequent to changes in gonadal steroid levels or to
simple exposure to levels above a critical threshold. Additionally, since the symptoms of
depression stimulated by hormone addback appeared to remit by the fourth week of hormone
administration, it is unclear whether continued administration of hormone would result in
continued or repeated experience of depression or whether no further symptoms would appear
subsequent to the initial precipitated episode. To address these points of uncertainty, we
first will establish the efficacy of gonadal suppression in our MRMD subjects by
administering depot leuprolide acetate for three months and then will administer both
estradiol and progesterone in a continuous fashion for three months to determine whether
maintenance of stable gonadal steroid levels will prevent the characteristic cyclic mood
disorder.
Eligibility
Ages Eligible for Study- Min: 18 Years Max: 50 Years
Gender: Female
Criteria
INCLUSION CRITERIA:
The subjects of this study will be women who meet the criteria for MRMD as described in
Protocol # 81-M-0126, The Phenomenology and Biophysiology of Menstrually-related Mood and
Behavioral Disorders. In brief, these criteria include the following:
1. History within the last two years of at least six months with menstrually-related
mood or behavioral disturbances of at least moderate severity--i.e., disturbances
that are distinct in appearance and associated with a notable degree of subjective
distress and interference with life activities;
2. Symptoms with a sudden offset and absence of significant symptomatology during the
follicular phase;
3. Age 18-50;
4. Regular menstrual cycles (21-35 days in length), not pregnant, and in good medical
health;
5. Not pregnant;
6. In good medical health;
5) Medication free.
All patients participating in this protocol will have already participated in Protocol No.
81-M-0126 and will have a prospectively confirmed and predictable relationship between
their mood disorder and the premenstrual phase of the menstrual cycle; i.e., a 30% change
in severity of symptom self rating scales, relative to the range of the scale employed,
during the seven days premenstrually compared with the seven days post-menstrually in two
out of three months of study. This method formed the basis of the NIMH PMS Workgroup
diagnostic guidelines and produces results that are highly convergent with the effect size
method for diagnosing PMS.
All subjects will be required to use non-hormonal forms of birth control (e.g. barrier
methods with the exception of IUD's) to avoid pregnancy during this study.
EXLUSION CRITERIA:
The following conditions, also, will constitute contraindications to treatment with
hormonal therapy and will preclude a patient's participating in this protocol:
1. Current Axis I psychiatric diagnosis
2. History of endometriosis;
3. Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian
enlargement;
4. Hepatic disease as manifested by abnormal liver function tests;
5. History of mammary carcinoma;
6. History of pulmonary embolism or phlebothrombosis;
7. Undiagnosed vaginal bleeding;
8. Porphyries;
9. Diabetes mellitus;
10. History of malignant melanoma;
11. Cholecystitis or pancreatitis;
12. Cardiovascular or renal disease;
13. Pregnancy;
14. Significant clinical or laboratory abnormalities
The subjects of this study will be women who meet the criteria for MRMD as described in
Protocol # 81-M-0126, The Phenomenology and Biophysiology of Menstrually-related Mood and
Behavioral Disorders. In brief, these criteria include the following:
1. History within the last two years of at least six months with menstrually-related
mood or behavioral disturbances of at least moderate severity--i.e., disturbances
that are distinct in appearance and associated with a notable degree of subjective
distress and interference with life activities;
2. Symptoms with a sudden offset and absence of significant symptomatology during the
follicular phase;
3. Age 18-50;
4. Regular menstrual cycles (21-35 days in length), not pregnant, and in good medical
health;
5. Not pregnant;
6. In good medical health;
5) Medication free.
All patients participating in this protocol will have already participated in Protocol No.
81-M-0126 and will have a prospectively confirmed and predictable relationship between
their mood disorder and the premenstrual phase of the menstrual cycle; i.e., a 30% change
in severity of symptom self rating scales, relative to the range of the scale employed,
during the seven days premenstrually compared with the seven days post-menstrually in two
out of three months of study. This method formed the basis of the NIMH PMS Workgroup
diagnostic guidelines and produces results that are highly convergent with the effect size
method for diagnosing PMS.
All subjects will be required to use non-hormonal forms of birth control (e.g. barrier
methods with the exception of IUD's) to avoid pregnancy during this study.
EXLUSION CRITERIA:
The following conditions, also, will constitute contraindications to treatment with
hormonal therapy and will preclude a patient's participating in this protocol:
1. Current Axis I psychiatric diagnosis
2. History of endometriosis;
3. Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian
enlargement;
4. Hepatic disease as manifested by abnormal liver function tests;
5. History of mammary carcinoma;
6. History of pulmonary embolism or phlebothrombosis;
7. Undiagnosed vaginal bleeding;
8. Porphyries;
9. Diabetes mellitus;
10. History of malignant melanoma;
11. Cholecystitis or pancreatitis;
12. Cardiovascular or renal disease;
13. Pregnancy;
14. Significant clinical or laboratory abnormalities
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00005011
More Information
Record Last Reviewed:December 2009
Last Updated:June 16, 2010
Record First Recieved:March 29, 2000
ClinicalTrials.gov Identifier:NCT00005011
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 08, 2010
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