A Phase 4 interventional study of fluoxetine in Premenstrual Dysphoric Disorder and Premenstrual Syndrome, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.
This study's enrollment of 45 is below the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months
Drug: fluoxetine
Fluoxetine 20 mg daily by mouth for 2-3 months.
Also known as: Prozac, Sarafem
Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment
GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
Time frame: 2-3 months post-treatment w/ fluoxetine.
45 subjects were recruited at an outpatient practice at Yale University, CT.
| Milestone | PMDD | Healthy Controls |
|---|---|---|
| Started | 18 | 27 |
| Completed | 18 | 27 |
| Not completed | 0 | 0 |
GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
No measurements were reported for this outcome.
Collected over Adverse event data was collected throughout the course of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluoxetine | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| No Treatment | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | PMDD Group | Healthy Controls | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 27 | 45 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | PMDD Group | Healthy Controls | Total |
|---|---|---|---|
| Female | 18 | 27 | 45 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | PMDD Group | Healthy Controls | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania