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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 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 45 participants.

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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

FieldValue
Enrollment Target 45 participants
Start Date 2006-08
Est. Completion 2008-06

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT00472615

The ClinicalTrials.gov registry entry for NCT00472615 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00472615 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.