PMDD Clinical Trials 2023

What Are PMDD Clinical Trials?

PMDD, or Premenstrual Dysphoric Disorder (PMDD), is a more severe form of Premenstrual Syndrome (PMS). It triggers symptoms like anxiety attacks, anger, panic attacks, and suicidal thoughts a week or two before the period starts, along with the usual PMS symptoms like bloating, headaches, and mood swings.

PMDD clinical trials are a way to better understand the condition, its potential treatments, and its association with other physiological and psychological conditions.

Why Is PMDD Being Studied Through Clinical Trials?

About 5% of women of childbearing age suffer from PMDD. That's equivalent to about 3.2 million women in the US alone. Severe PMDD symptoms can have adverse psychological and social implications for women with this condition.

There is a dire need for safe medical interventions to help with the treatment, mitigation, or control of PMDD symptoms. Therefore, most PMDD clinical trials focus on the safe and efficient treatment of PMDD.

What Are The Types of Treatments Available For PMDD?

Drug therapy/medicine is the most common type of treatment available for PMDD. Different drug therapies that are found useful, efficient, and relatively safe are:

• Selective Serotonin Reuptake Inhibitors (SSRIs) are antidepressants that are quite effective for many individuals suffering from PMDD. They have helped alleviate the symptoms in 60% to 75% of the samples studied for their effect.
• Continuous use of contraceptives has also been found useful in treating PMDD symptoms. However, only one contraceptive has been approved by the FDA for this treatment - YAZ.

Hormone therapies are considered the second-line treatment, and dietary changes and vitamins might be mildly successful in alleviating PMDD symptoms. Psychological therapies, counseling, and self-help are useful in treating psychological symptoms associated with PMDD.

What Are Some Recent Breakthrough Clinical Trials For PMDD?

The clinical trials on PMDD are highly concentrated on certain treatment avenues, which has resulted in a severe lack of breakthroughs regarding alternative treatments in the last decade.

2017: Randomized Controlled Trial For PMDD Treatment With Sepranolone (UC1010) - A group of 106 women completed phase II of the clinical trial, out of which 60 were classified as pure PMDD patients. The DRSP scores were 75% lower for women receiving UC1010 compared to 47% receiving placebo. No side effects were found, and it's expected to become a viable alternative to SSRIs and contraceptives.

2017: Dysregulation of ESC/E(Z) complex May Contribute To PMDD - Women suffering from PMDD may have abnormal responsiveness to ovarian steroids compared to their healthy peers. A clinical trial of a control group of 24 women suffering from PMDD, compared against a similar-sized sample, revealed that irregularities in the ESC/E(Z) complex function may contribute to PMDD.

Who Are Some Of The Key Opinion Leaders / Researchers / Institutions Conducting PMDD Clinical Trial Research?

University of North Carolina, Chapel Hill - The University of North Carolina has sponsored and conducted three out of 35 clinical trials currently in the Clinical Trial registry. Two of them were in collaboration with the National Institute of Mental Health (NIMH).

Peter Schmidt - Peter Schmidt leads the Behavioral Endocrinology Branch of the NIMH, which has sponsored or contributed to ten out of 35 clinical trials on PMDD. He leads a workgroup on PMDD and has at least three major publications on the subject.