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NCT00100360 · ClinicalTrials.gov registry record
Hormonal Causes of Menstrual-Related Mood Disorders
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 22
- Enrollment target
NCT00100360: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT00100360 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00100360 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study Summary
This study will explore possible hormonal causes of menstrual-related mood disorders (MRMD) by stopping the menstrual cycle with a drug called Lupron and then giving in sequence two menstrual cycle hormones, progesterone and estrogen. The study will first evaluate Lupron's effectiveness in treating MRMD and will then examine the effects of giving estrogen and progesterone on mood and behavior. In addition, positron emission tomography (PET) and magnetic resonance imaging (MRI) will be used to study serotonin receptors and transporters - molecules in the brain that are thought to play a major role in mood changes related to the menstrual cycle. Menstruating women between 18 and 50 years of age who are in good health, not pregnant, and not taking medications may be eligible for this study. Women with MRMD must have had at least moderately severe MRMD or behavioral disturbances for at least 6 months within 2 years of entering the study. Healthy controls must have no history of MRMD or behavioral disturbances. Candidates undergo physical and neurological examinations, chest x-ray, electrocardiogram, and blood and urine tests. Results of a recent Pap smear (no longer than 12 months before beginning the study) must be available. Participants undergo the following tests and procedures: * Drug treatment: Lupron is injected into a muscle once a month for 5 months. After the second month, participants receive estrogen or progesterone, or both, daily. Estrogen is delivered through a skin patch (20 micrograms per day) and the progesterone is taken as a rectal or vaginal suppository twice a day for the remaining 12 weeks of the study. Every day, all participants wear a skin patch and insert two suppositories, but at some point during the 12 weeks, active medication is replaced with placebo to allow the drugs to wash out of the body. * Physical examination and blood draw: A physical examination and blood tests are done at the start of the study and several times during the stu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2004-12-22 |
| Est. Completion | 2016-12-15 |
What the finished NCT00100360 record still lists
NCT00100360 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00100360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00100360 about?
NCT00100360 is a clinical study titled "Hormonal Causes of Menstrual-Related Mood Disorders". This study will explore possible hormonal causes of menstrual-related mood disorders (MRMD) by stopping the menstrual cycle with a drug called Lupron and then giving in sequence two menstrual cycle hormones, progesterone and estrogen. The study will first evaluate Lupron's effectiveness in treating ...
What is the current status of trial NCT00100360?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2004-12-22. Estimated completion is 2016-12-15.
Who is sponsoring clinical trial NCT00100360?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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