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NCT00472615 · ClinicalTrials.gov registry record
Menstrual Effects On Mood Symptoms in Bipolar Disorder
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 45
- Enrollment target
NCT00472615: Completed study, sponsored by University of Pittsburgh.
NCT00472615 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00472615 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking. Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-06 |
What the finished NCT00472615 record still lists
NCT00472615 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00472615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00472615 about?
NCT00472615 is a clinical study titled "Menstrual Effects On Mood Symptoms in Bipolar Disorder". Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfo...
What is the current status of trial NCT00472615?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2006-08. Estimated completion is 2008-06.
Who is sponsoring clinical trial NCT00472615?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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