View clinical trials related to Premenstrual Dysphoric Disorder.
Filter by:This research study will look at differences among women with severe premenstrual mood symptoms. One goal of this study is to look at how the brains of two groups of these women respond to emotional information. The two groups are women who were abused early in life and women who were not. The study will use a brain scan to look at how certain areas of the brain respond to the viewing of words and pictures. Another goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on those same brain areas during the viewing of words and pictures. Also, the investigators will look at whether oxytocin given in the nose improves premenstrual mood symptoms.
Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are limited, with 40% non-responders. Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is based on modulating neural activity by inducing an electric field in the brain. To date, dTMS was found to be an effective treatment for depression, which is highly comorbid with PMDD. The investigators propose to study the effect of dTMS on PMDD patients in a prospective treatment study.
Purpose: Using transcranial alternating current stimulation (tACS), we will study whether tACS induces changes in prefrontal alpha oscillatory frequencies in women with premenstrual dysphoric disorder (PMDD) and whether tACS effects on alpha oscillations varies by menstrual cycle phase. An exploratory objective is to assess whether there are any changes in symptom severity during the menstrual cycle phase in which tACS is delivered relative to their baseline symptom levels (determined in a diagnostic feeder study, see below). Participants: Women between ages 18-52 with a diagnosis of PMDD confirmed by participation in a PMDD diagnostic study (IRB# 05-3000). Procedures (methods): After a re-screening and consent appointment, eligible participants will alert the study staff when they begin menstruating. Participants will have their first session in either the follicular phase or luteal phase (determined by ovulation testing) of their menstrual cycle and the second session in the other cycle phase. The order of phase at first testing will be counterbalanced across participants. Each session will consist of 40 minutes of tACS with by an EEG recording before and after stimulation. Patients' symptoms will be assessed at the end of each session and with the daily mood ratings collected throughout the menstrual cycle that coincides with tACS sessions (approximately 26 - 32 days).
Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, ~40% do not respond to conventional treatment options. In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives.
The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1. In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.
The primary aim of this study is to examine the effects of co-administered wake therapy followed by light treatment on mood, and secondarily on circadian rhythms, to test the hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances in melatonin and sleep in women with Premenstrual Dysphoric Disorder.
The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.
The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD).
The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given every day for three months). The primary hypothesis is that continuous OC will be significantly more effective in reducing premenstrual symptoms compared with either the interrupted OC or continuous placebo.
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.