Research Center: The University of Texas Southwestern Medical Center
Location: 1440 Empire Central Drive, Ste LD4.100, Dallas, TX 75247
Lead Researchers: Sherwood Brown, MD, PhD, MBA and Marlene Freeman, MD
IRB: This study has been reviewed and approved by the UT Southwestern Medical Center Institutional Review Board

A number of women grapple with depression symptoms during perimenopause and menopause, yet current treatments often fall short in alleviating these challenging conditions. In response, researchers from the University of Texas Southwestern Medical Center are spearheading an innovative study to explore alternative treatments.

Researchers hope that the information learned from this research study will benefit other women with menopausal depression in the future, and are hopeful that the Information gained from this research could lead to better treatment for women experiencing depression during the menopausal transition. If you find yourself dealing with depression symptoms linked to menopause or perimenopause, consider joining this study! It is an opportunity to contribute to a future where women’s well-being takes center stage. Your participation could pave the way for enhanced understanding and support for women everywhere!

• Participants will receive a new potential treatment for depression related to menopause or perimenopause at no cost.
• Participants will be compensated up to $650 for participating in this study. 
• Participants may potentially experience improvements in symptoms associated with depression caused by menopause or perimenopause. 
• Participants will be contributing valuable information that may benefit those with women in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Women aged 40-67 who are experiencing menopause or perimenopause
• Must be experiencing depression
• Must not have a history of non-response to electroconvulsive therapy
• Must not have a history of treatment-resistant depression. Note:
• This means that at least 2 medications have been tried and neither of the 2 medications provided improvement in depression symptoms
• Must not have any of the following medical conditions: Untreated hypertension, active coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis, pulmonary embolism, or a blood clotting disorder
• Must not have a history or first-degree family history of known hormone-sensitive tumors (ie, breast cancer or uterine cancer)
• Must not have experienced any allergic reactions or side effects to pregnenolone
• Must be able and willing to participate in the study for approximately 16 weeks

The study team will explain the research in its entirety but some details are:

• Participants will take part in procedures and evaluations during the research study (Most visits will be conducted virtually, and 3 visits will be in-person).
• Participants will be asked to take the study medication. They may be taking pregnenolone or placebo capsules.
• Participation in this study will last 16 weeks, with a safety follow-up phone call (non-data collection) at Week 17.

The University of Texas Southwestern Medical Center
UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty includes many distinguished members, including six who have been awarded Nobel Prizes since 1985. The faculty of more than 2,800 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in about 80 specialties to more than 105,000 hospitalized patients, and nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.