Home Women Health Recruiting for Research Study: Pregnenolone Neurosteroid for Menopausal Depression

Recruiting for Research Study: Pregnenolone Neurosteroid for Menopausal Depression

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Recruiting for Research Study: Pregnenolone Neurosteroid for Menopausal Depression

Over the previous few years we’ve heard an important deal about neurosteroids, also often called neuroactive steroids.  This class of compounds are steroid hormones produced within the brain and endocrine tissues which may modulate neurotransmission.  Animal studies have demonstrated that neurosteroids have a broad range of activities, including antidepressant, anxiolytic, sedative, analgesic, anticonvulsant, neuroprotective, and neuroproliferative effects.  

While we’ve known about neuroactive effects of steroids for the reason that Nineteen Forties, it has been difficult to copy the useful effects of naturally produced neurosteroids with similar compounds synthesized within the laboratory.  Several different neurosteroids have been tested as anticonvulsants and anaesthetic agents; nevertheless, we’ve seen probably the most  robust clinical findings with several different derivatives of allopregnanolone used as antidepressants.   Certainly one of these allopregnanolone analogues, brexanolone, was approved last yr by the FDA for the treatment of severe postpartum depression and is now being marketed as Zulresso (Sage Therapeutics).

Allopregnanolone is produced by the human body as a byproduct of progesterone.  Some have speculated that shifting levels of allopregnanolone may play a job within the pathophysiology of reproductive hormone-associated mood disorders, including premenstrual dysphoric disorder (PMDD) and menopausal depression.  Given the positive results of brexanolone for postpartum depression, there was considerable interest in exploring the effectiveness of comparable neurosteroids in women with other forms of reproductive hormone-associated mood disorders.  

In a brand new study, Dr. Marlene Freeman and colleagues on the Center for Women’s Mental Health will investigate the effectiveness of pregnenolone, a neurosteroid which is a derivative of progesterone, for the treatment of depression in the course of the menopausal transition.  Pregnenolone is produced within the body and is involved within the synthesis and metabolism of other steroid hormones, including progestogens and estrogens.  Pregnenolone is biologically lively and modulates various neurotransmitter systems, including the endocannabinoid system. Its metabolite pregnenolone sulfate is analogous to brexanolone and acts as a negative allosteric modulator of the GABA-A receptor and can also be a positive allosteric modulator of the NMDA receptor.

Each preclinical and human data suggest that pregnenolone could also be a promising treatment for depression. Dr. Freeman’s study will test the effectiveness of pregnenolone in women with menopausal depression.  


Eligibility: This study is recruiting women between the ages of 40 and 67 who’re perimenopausal (changes in menstrual cycle and/or physical symptoms of menopause) OR early postmenopausal (inside 5 years of the last menstrual period).

Study Participation: Participants can be randomized into one among two treatment groups (placebo or pregnenolone) and can be asked to finish questionnaires about mood, cognitive function, demographic and medical history, psychiatric history, and menopausal symptoms.  All evaluations and medications included as a part of this study could be provided without charge.  

Time Commitment: 16 weeks with 3 in-person visits at MGH and 6 virtual visits. 

Compensation: As much as $390 for participating within the 16-week study.

For information, you may contact Lauren at LKOBYLSKI@mgh.harvard.edu.  You can even read more about this study HERE.

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